US-FDA and Pharmacy Compounding

Note: Though in the Philippines community pharmacists do not much practice compounding anymore, it is essential to know that compounding medicines in other countries (like USA) is still valid and practiced. In the Philippines it is not totally eradicated as a function of community pharmacists, as a matter of fact some community pharmacies and hospital pharmacies are still compounding medicines but valid only when the treatment calls for a drug preparation that does not occur as pre-manufactured drug.

How to Dispose of Unused Medicines

Is your medicine cabinet filled with expired drugs or medications you no longer use? How should you dispose of them?

Most drugs can be thrown in the household trash, but consumers should take certain precautions before tossing them out, according to the Food and Drug Administration (FDA). A few drugs should be flushed down the toilet. And a growing number of community-based "take-back" programs offer another safe disposal alternative.

Guidelines for Drug Disposal

FDA worked with the White House Office of National Drug Control Policy (ONDCP) to develop the first consumer guidance for proper disposal of prescription drugs. Issued by ONDCP in February 2007 and updated in October 2009, the federal guidelines are summarized here:

• Follow any specific disposal instructions on the drug label or patient information that accompanies the medication. Do not flush prescription drugs down the toilet unless this information specifically instructs you to do so.
• Take advantage of community drug take-back programs that allow the public to bring unused drugs to a central location for proper disposal. Call your city or county government's household trash and recycling service (see blue pages in phone book) to see if a take-back program is available in your community. The Drug Enforcement Administration, working with state and local law enforcement agencies, is sponsoring National Prescription Drug Take Back Days throughout the United States.
• If no instructions are given on the drug label and no take-back program is available in your area, throw the drugs in the household trash, but first:
  • Take them out of their original containers and mix them with an undesirable substance, such as used coffee grounds or kitty litter. The medication will be less appealing to children and pets, and unrecognizable to people who may intentionally go through your trash.
  • Put them in a sealable bag, empty can, or other container to prevent the medication from leaking or breaking out of a garbage bag.

FDA's Deputy Director of the Office of Compliance Ilisa Bernstein, Pharm.D., J.D., offers some additional tips:

• Before throwing out a medicine container, scratch out all identifying information on the prescription label to make it unreadable. This will help protect your identity and the privacy of your personal health information.
• Do not give medications to friends. Doctors prescribe drugs based on a person's specific symptoms and medical history. A drug that works for you could be dangerous for someone else.
• When in doubt about proper disposal, talk to your pharmacist.

Bernstein says the same disposal methods for prescription drugs could apply to over-the-counter drugs as well.

Why the Precautions?

Disposal instructions on the label are part of FDA's "risk mitigation" strategy, says Capt. Jim Hunter, R.Ph., M.P.H., senior program manager on FDA's Controlled Substance Staff. When a drug contains instructions to flush it down the toilet, he says, it's because FDA, working with the manufacturer, has determined this method to be the most appropriate route of disposal that presents the least risk to safety.

Drugs such as powerful narcotic pain relievers and other controlled substances carry instructions for flushing to reduce the danger of unintentional use or overdose and illegal abuse.
For example, the fentanyl patch, an adhesive patch that delivers a potent pain medicine through the skin, comes with instructions to flush used or leftover patches. Too much fentanyl can cause severe breathing problems and lead to death in babies, children, pets, and even adults, especially those who have not been prescribed the drug. "Even after a patch is used, a lot of the drug remains in the patch," says Hunter, "so you wouldn't want to throw something in the trash that contains a powerful and potentially dangerous narcotic that could harm others."

Environmental Concerns

Despite the safety reasons for flushing drugs, some people are questioning the practice because of concerns about trace levels of drug residues found in surface water, such as rivers and lakes, and in some community drinking water supplies. However, the main way drug residues enter water systems is by people taking medications and then naturally passing them through their bodies, says Raanan Bloom, Ph.D., an environmental assessment expert in FDA's Center for Drug Evaluation and Research. "Most drugs are not completely absorbed or metabolized by the body, and enter the environment after passing through waste water treatment plants."

A company that wants FDA to approve its drug must submit an application package to the agency. FDA requires, as part of the application package, an assessment of how the drug's use would affect the environment. Some drug applications are excluded from the assessment requirement, says Bloom, based on previous agency actions.

"For those drugs for which environmental assessments have been required, there has been no indication of environmental effects due to flushing," says Bloom. In addition, according to the Environmental Protection Agency, scientists to date have found no evidence of adverse human health effects from pharmaceutical residues in the environment.

Nonetheless, FDA does not want to add drug residues into water systems unnecessarily, says Hunter. The agency reviewed its drug labels to identify products with disposal directions recommending flushing or disposal down the sink. This continuously revised listing can be found at FDA's Web page on Disposal of Unused Medicines.

Another environmental concern lies with inhalers used by people who have asthma or other breathing problems, such as chronic obstructive pulmonary disease. Traditionally, many inhalers have contained chlorofluorocarbons (CFC's), a propellant that damages the protective ozone layer. The CFC inhalers are being phased out and replaced with more environmentally friendly inhalers.

Depending on the type of product and where you live, inhalers and aerosol products may be thrown into household trash or recyclables, or may be considered hazardous waste and require special handling. Read the handling instructions on the label, as some inhalers should not be punctured or thrown into a fire or incinerator. To ensure safe disposal, contact your local trash and recycling facility.

Pharmacy Compounding and the FDA: Questions and Answers

What is “compounding”? 

Pharmacy compounding is a practice in which a licensed pharmacist combines, mixes, or alters ingredients of a drug in response to a prescription to create a medication tailored to the medical needs of an individual patient.

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Is combining two or more drugs considered compounding?

Yes, if it is done by a pharmacist in response to a licensed practitioner’s prescription and produces a medication tailored to an individual patient’s special medical needs.

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Why do some patients need compounded drugs?

Pharmacy compounding can serve an important public health need if a patient cannot be treated with an FDA-approved medication. Some examples of the need for compounding include:

• If a patient has an allergy and needs a medication to be made without a certain dye.
• If an elderly patient or a child can’t swallow a pill and needs a medicine in a liquid form that is not otherwise available.

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Are compounded drugs approved by the FDA?

Compounded drugs are not FDA-approved. This means that FDA does not verify the quality, safety and effectiveness of compounded drugs. This also means that compounded drugs lack an FDA finding of manufacturing quality. Consumers and health professionals rely on the drug approval process to ensure that drugs are safe and effective.

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Who regulates and inspects compounding pharmacies?

Each compounding pharmacy is licensed by its state’s board of pharmacy, which has primary responsibility for day-to-day oversight. The FDA's regulatory authority over certain compounding pharmacies is more limited than its authority over other drug manufacturers. For example, compounded drugs are not FDA approved.  In addition, compounding pharmacies are not generally required to register with FDA and therefore do not tell FDA what drugs they are making.

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What are the risks associated with compounded drugs?

Compounded drugs can pose both direct and indirect health risks.

• Direct health risks include unsafe compounded products. Compounded drugs made using poor quality compounding practices may be sub- or super‑potent, contaminated, or otherwise adulterated.
• Indirect health risks include the possibility that patients will use ineffective compounded drugs instead of FDA-approved drugs that have been shown to be safe and effective. 

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Does FDA want to prevent traditional pharmacy compounding?

No.  FDA believes that pharmacists engaging in traditional pharmacy compounding provide a valuable medical service that is important to patient health.


Note: Though in the Philippines community pharmacists do not much practice compounding anymore, it is essential to know that compounding medicines in other countries (like USA) is still valid and practiced. In the Philippines it is not totally eradicated as a function of community pharmacists, as a matter of fact some community pharmacies and hospital pharmacies are still compounding medicines but valid only when the treatment calls for a drug preparation that does not occur as pre-manufactured drug.

Don’t Double Up on Acetaminophen (Paracetamol)

You have flu symptoms, so you've been getting some relief for the past two days by taking a cough and flu medicine every few hours. Late in the day, you have a headache and you think about grabbing a couple of acetaminophen tablets to treat the pain.

Stop right there.

What you may not realize is that more than 600 medications, both prescription and over-the-counter (OTC), contain the active ingredient acetaminophen to help relieve pain and reduce fever. Taken carefully and correctly, these medicines can be safe and effective. But taking too much acetaminophen can lead to severe liver damage.

Acetaminophen is a common medication for relieving mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches and to reduce fever. It is also used in combination medicines, which have more than one active ingredient to treat more than one symptom.

'Tis Cold and Flu Season

The National Institutes of Health (NIH) says that Americans catch one billion colds per year and as many as 20% of Americans get the flu. Moreover, 7 in 10 Americans use OTC medicines to treat cold, cough and flu symptoms.

Fathia Gibril, M.D., M.HSc., a supervisory medical officer at the Food and Drug Administration (FDA), explains that consumers looking for relief from a cold or the flu may not know that acetaminophen comes in combination with many other medications used to treat those symptoms. "So if you're taking more than one medicine at a time," she says, "you may be putting yourself at risk for liver damage."

Symptoms of acetaminophen overdose may take many days to appear, and even when they become apparent, they may mimic flu or cold symptoms. The current maximum recommended adult dose of acetaminophen is 4,000 milligrams per day, To avoid exceeding that dose:

• don't take more than one OTC product containing acetaminophen,
• don't take a prescription and an OTC product containing acetaminophen, and
• don't exceed the recommended dose on any product containing acetaminophen.

"When you're at the store deciding which product to buy, check the 'Drug Facts' label of OTC cold, cough and flu products before using two or more products at the same time," Gibril says. If you’re still not sure which to buy, ask the pharmacist for advice.
FDA has an online list of brand names of products containing acetaminophen.

Rely on Health Care Experts

Acetaminophen is used in many commonly prescribed medications in combination with pain relievers such as codeine, oxycodone and hydrocodone. As of January 2011, FDA reported that overdoses from prescription medicines containing acetaminophen accounted for nearly half of all cases of acetaminophen-related liver injury in the U.S. When your health care professionals prescribe a drug, be sure to ask if it contains this active ingredient, and also to inform them of all other medicines (prescription and OTC) and supplements you take.

Even if you still have fever or pain, it's important not to take more than directed on the prescription or package label, notes FDA supervisory medical officer Sharon Hertz, M.D. But be careful, the word "acetaminophen" is not always spelled out in full on the container's prescription label. Abbreviations such as APAP, Acetaminoph, Acetaminop, Acetamin, or Acetam may be used instead.

When buying OTC products, Hertz suggests you make it a habit of telling the pharmacist what other medications and supplements you’re taking and asking if taking acetaminophen in addition is safe.
When the medicine is intended for children, the "Directions" section of the Drug Facts label tells you if the medicine is right for your child and how much to give. If a dose for your child's weight or age is not listed on the label and you can't tell how much to give, ask your pharmacist or doctor what to do.

If you're planning to use a medication containing acetaminophen, you should tell your health care professional if you have or have ever have had liver disease.

Acetaminophen and alcohol may not be a good mix, either, Hertz says. If you drink three or more alcoholic drinks a day, be sure to talk to your health care professional before you use a medicine containing acetaminophen. (USFDA)

Ten Tips to Prevent an Accidental Overdose

For a medicine to work for you—and not against you—you’ve got to take the right dose.

Many over-the-counter liquid medicines—such as pain relievers, cold medicine, cough syrups, and digestion aids—come with spoons, cups, oral droppers, or syringes designed to help consumers measure the proper dose. These “dosage delivery devices” usually have measurement markings on them—such as teaspoons (tsp), tablespoons (tbsp), or milliliters (mL).

But the markings aren’t always clear or consistent with the directions on the medicine’s package. The Food and Drug Administration (FDA) has received numerous reports of accidental overdoses—especially in young children—that were attributed, in part, to the use of dosage delivery devices that were unclear or incompatible with the medicine’s labeled directions for use.

On May 4, 2011, FDA issued a guidance to firms that manufacture, market, or distribute over-the-counter liquid medicines. The guidance calls for them to provide dosage delivery devices with markings that are easy to use and understand.

Parents and caregivers can do their part, too, to avoid giving too much or too little of an over-the-counter medicine. Here are 10 tips:

1. Always follow the directions on the Drug Facts label of your medicine. Read the label every time before you give the medicine.
2. Know the "active ingredient" in the medicine. This is what makes the medicine work and it is always listed at the top of the Drug Facts label. Many medicines used to treat different symptoms have the same active ingredient. So if you're treating a cold and a headache with two different medicines but both have the same active ingredient, you could be giving two times the normal dose. If you're confused, check with a doctor, nurse, or pharmacist.
3. Give the right medicine, in the right amount. Medicines with the same brand name can be sold in different strengths, such as infant, children, and adult formulas. The dose and directions also vary for children of different ages or weights. Always use the right strength and follow the directions exactly. Never use more medicine than directed unless your doctor tells you to do so.
4. Talk to your doctor, pharmacist, or nurse to find out what mixes well and what doesn't. Medicines, vitamins, supplements, foods, and beverages aren’t always compatible.
5. Use the dosage delivery device that comes with the medicine, such as a dropper or a dosing cup. A different device, or a kitchen spoon, could hold the wrong amount of medicine. And never drink liquid medicine from the bottle.
6. Know the difference between a tablespoon (tbsp) and a teaspoon (tsp). A tablespoon holds three times as much medicine as a teaspoon. On measuring tools, a teaspoon (tsp) is equal to "5 mL."
7. Know your child's weight. Dosage amounts for some medicines are based on weight. Never guess how much to give your child or try to figure it out from the adult dose instructions. If a dose is not listed for your child's weight, call your health care professional.
8. Prevent a poison emergency by always using a child-resistant cap. Relock the cap after each use. Be especially careful with any medicines that contain iron; they are the leading cause of poisoning deaths in young children.
9. Store all medicines in a safe place. Some are tasty, colorful, and many can be chewed. Kids may think they’re candy. Store all medicines and vitamins out of your child's (and your pet's) sight and reach. If your child takes too much, call the Poison Center Hotline at 800-222-1222 (open 24 hours a day, 7 days a week) or call 9-1-1.
10. Check the medicine three times before using. For any medicine, it is always good practice to first, check the outside packaging for such things as cuts, slices, or tears. Second, once you’re at home, check the label on the inside package to be sure you have the right medicine and that the lid and seal are not broken. Third, check the color, shape, size, and smell. If you notice anything unusual, talk to a pharmacist or other health care professional before using.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

Know Active Ingredients in Children's Meds

Ah-choo!

If your child is sneezing up a storm, it must be allergy season once more.

And if your child is taking more than one medication at the same time, there could be dangerous health consequences if those medicines have the same active ingredient, according to Hari Cheryl Sachs, M.D., a pediatrician at the Food and Drug Administration (FDA).

A medicine is made of many components. Some are "inactive" and only help it to taste better or dissolve faster, while others are active. An active ingredient in a medicine is the component that makes it pharmaceutically active—it makes the medicine effective against the illness or condition it is treating.
Active ingredients are listed first on a medicine's Drug Facts label for over-the-counter (OTC) products. For prescription medicines, they are listed in a patient package insert or consumer information sheet provided by the pharmacist.

Many medicines have just one active ingredient. But combination medicines, such as those for allergy, cough, or fever and congestion, may have more than one.

Take antihistamines taken for allergies. "Too much antihistamine can cause sedation and—paradoxically—agitation. In rare cases, it can cause breathing problems, including decreased oxygen or increased carbon dioxide in the blood, Sachs says.

"We're just starting allergy season," says Sachs. "Many parents may be giving their children at least one product with an antihistamine in it." Over-the-counter (OTC) antihistamines (with brand name examples) include diphenhydramine (Benadryl), chlorpheniramine (Chlor-Trimeton), clemastine (Tavist), fexofenadine (Allegra), loratadine (Claritin, Alavert), and cetirizine (Zyrtec).

But parents may also be treating their children for a separate ailment, such as a cough or cold. What they need to realize is that more than one combination medicine may be one too many.
"It's important not to inadvertently give your child a double dose," Sachs says.

Other Health Complications

The same goes for other active ingredients, often found in combination products for allergies but also used to treat other symptoms, such as fever, headache or nasal congestion:

• Acetaminophen (in Tylenol and many other products), a pain reliever often used to treat fevers, mild pain or headache. Taking too much can cause liver damage.
• Ibuprofen (for example, Advil or Motrin), another common medicine for relieving mild to moderate pain from headaches, sinus pressure, muscle aches and flu, as well as to reduce fever. Too much ibuprofen can cause nausea, vomiting, diarrhea, severe stomach pain, even kidney failure.
• Decongestants such as pseudoephedrine or phenylephrine (found in brand name drugs such as Actifed and Sudafed) taken in large amounts can cause excessive drowsiness in children. They can also cause heart rhythm disturbances, especially if combined with products and foods containing caffeine. In the form of nasal sprays and nose drops, these products, as well as oxymetazoline (the active ingredients in products such as Afrin), can cause "rebound" congestion, in which the nose remains stuffy or gets even worse.

Any of the above symptoms may indicate a need for immediate medical attention. "The bottom line is that neither you, nor your children, should take multiple combination medicines at the same time without checking the active ingredients and consulting your health care professional first," recommends Sachs.

Furthermore, two different active ingredients may serve the same purpose, Sachs says. For example, both acetaminophen and ibuprofen help reduce pain and fever. So there's generally no need to give your child both medicines for the same symptoms.

Write It All Down

Whether you're treating your child's condition with OTC medicines from the drug store or ones prescribed by your doctor, it's essential that you keep track of every medicine and the active ingredients each contains, Sachs says.

"It's easy to forget which medicines you're giving your child," Sachs says. "And if you have more than one child, it can get even more complicated." She recommends making it a habit to write down the name of any medicine you give your child, whether it's OTC or prescription (download a daily medicine records template).

"It's really a good idea to carry that list with you when you go to see your pediatrician or even when you go to the pharmacy," she adds. You should also note whatever vitamins or supplements your child is taking, as these can interact unfavorably with certain medicines, too.

Most importantly, Sachs says parents should always read the Drug Facts label on OTC products, and the patient package insert or consumer information sheet that comes with prescription medicines, every time they're considering a medication for their child, even if they think they already know the ingredients. They should know that the ingredients can change without an obvious change in the packaging. And they should contact their health care professional with any questions.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products. (Excerpt from USFDA, March 12, 2013)

Know the Risks of Indoor Tanning

Using ultraviolet (UV) tanning lamps, like those used in indoor tanning beds, increases the risk of skin damage, skin cancer and eye injury, according to the Food and Drug Administration (FDA) and numerous other health organizations.

According to the American Cancer Society, melanoma—the deadliest form of skin cancer—accounted for 75,000 cases of skin cancer in 2012. According to the American Academy of Dermatology, indoor tanners are 75 percent more likely to develop melanoma than those who have never tanned indoors, and the risk increases with use.

To help protect consumers from the risks of indoor tanning, FDA is proposing changes in its regulation of sunlamps. The proposals are to enhance oversight of these devices, and to require labeling to include a recommendation designed to warn young people under the age of 18 not to use these devices.

This is due to concerns about long-term effects of exposure to dangerous UV rays. Because the effects add up over a lifetime, UV exposure in children and teenagers puts them at greater risk for skin and eye damage later in life.

Proposed Changes

FDA regulates sunlamp products (including tanning beds and booths) both as medical devices and radiation-emitting products. Manufacturers of sunlamps must comply with FDA regulations regarding these devices.
Based on new risk information and recommendations from experts at an earlier FDA Medical Device Advisory Committee meeting, the agency is proposing to reclassify these devices from Class I to Class II. FDA can exert more regulatory control over Class II devices, notes FDA medical device expert Neil Ogden.

For example, sunlamps would have to undergo premarket review and comply with requirements relating to performance testing, software validation and biocompatibility. "We believe the reclassification will not only strengthen oversight of sunlamp products, but also will ensure that consumers are better informed about and protected from this sort of exposure," he explains.

In addition, FDA is proposing that manufacturers add a label to the sunlamp warning young people not to use these devices. The World Health Organization, the American Academy of Pediatrics, the American Academy of Dermatology, the American Medical Association and other organizations have previously supported what the FDA is now proposing: a recommendation that minors refrain from indoor tanning.
The proposed order will be published in the Federal Register at www.regulations.gov and FDA will take public comments for 90 days.

FDA also is proposing that sunlamp product labeling include a warning that people who are repeatedly exposed to sunlamp products see their health care professional on a regular basis to check for possible skin cancer.

Skin Cancer Risk

"There is increasing evidence that tanning in childhood to early adult life increases the risk of skin cancer, including melanoma," says FDA dermatologist Markham Luke, M.D. In fact, according to an overview of studies recently published in the journal Pediatrics, melanoma is the second most common cancer in women in their 20s and the third most common cancer in men in their 20s in the U.S. Luke adds that many experts believe that at least one cause is the increased use of sunlamp products by U.S. teenagers and young adults.
The overview in Pediatrics suggests that doses of UV-A ultraviolet radiation emitted by high pressure tanning units may be up to 10 to 15 times higher than that of the midday sun, an intense exposure not found in nature. UV-A rays penetrate to the deeper layers of the skin and are often associated with allergic reactions, such as a rash. This is not to say that tanning outdoors is a safe activity. WHO has classified all UV radiation as carcinogenic (cancer causing).

Practices to Avoid

FDA's proposal seeks to provide a reasonable assurance of safety and to make prospective users of sunlamps aware of the risks they face. Certain practices involving sunlamps are especially dangerous. These include:

• failing to wear goggles—this can lead to short- and long-term eye injury.
• starting with long exposures (close to the maximum time for the particular sunlamp), which can lead to burning. Because sunburn takes 6 to 48 hours to develop, you may not realize your skin is burned until it's too late.
• failing to follow manufacturer-recommended exposure times on the label for your skin type (some skin types should not tan with UV radiation at all, for example those with skin that burns easily and doesn't readily tan).
• tanning while using certain medications or cosmetics that may make you more sensitive to UV rays. Talk to your doctor or pharmacist first.

This article appears on FDA's Consumer Update page, which features the latest on all FDA-regulated products. (From USFDA, May 7, 2013)

FDA approves the first non-hormonal treatment for hot flashes associated with menopause

The U.S. Food and Drug Administration today approved Brisdelle (paroxetine)to treat moderate to severe hot flashes (vasomotor symptoms) associated with menopause. Brisdelle, which contains the selective serotonin reuptake inhibitor paroxetine mesylate, is currently the only non-hormonal treatment for hot flashes approved by the FDA.

 

There are a variety of FDA-approved treatments for hot flashes, but all contain either estrogen alone or estrogen plus a progestin.

 

Hot flashes associated with menopause occur in up to 75 percent of women and can persist for up to five years, or even longer in some women. Hot flashes are not life-threatening, but the symptoms can be very bothersome, causing discomfort, embarrassment and disruption of sleep.

 

“There are a significant number of women who suffer from hot flashes associated with menopause and who cannot or do not want to use hormonal treatments,” said Hylton V. Joffe, M.D., M.M.Sc., director of the Division of Bone, Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval provides women with the first FDA-approved, non-hormonal therapeutic option to help ease the hot flashes that are so common in menopause.”

 

The safety and effectiveness of Brisdelle were established in two randomized, double-blind, placebo-controlled studies in a total of 1,175 postmenopausal women with moderate to severe hot flashes (a minimum of seven to eight per day or 50-60 per week). The treatment period lasted 12 weeks in one study and 24 weeks in the other study. The results showed that Brisdelle reduced hot flashes compared to placebo. The mechanism by which Brisdelle reduces hot flashes is unknown.

 

The most common side effects in patients treated with Brisdelle were headache, fatigue, and nausea/vomiting.  

 

Brisdelle contains 7.5 mg of paroxetine and is dosed once daily at bedtime. Other medications such as Paxil and Pexeva contain higher doses of paroxetine and are approved for treating conditions such as major depressive disorder, obsessive-compulsive disorder, panic disorder and generalized anxiety disorder. All medications that are approved for treating depression, including Paxil and Pexeva, have a Boxed Warning about an increased risk of suicide in children and young adults. Because Brisdelle contains the same active ingredient as Paxil and Pexeva, a Boxed Warning about suicidality is included in the Brisdelle label.

 

Additional labeled warnings include a possible reduction in the effectiveness of tamoxifen if both medications are used together, an increased risk of bleeding, and a risk of developing serotonin syndrome (signs and symptoms can include confusion, rapid heart rate, and high blood pressure). Brisdelle will be dispensed with a Medication Guide that informs patients of the most important information about the medication. The Medication Guide will be distributed to patients each time the prescription is refilled.

 

Consumers and health care professionals are encouraged to report adverse reactions from the use of Brisdelle to the FDA MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 1-800-FDA-1088.

 

Brisdelle and Pexeva are marketed by Noven Therapeutics, LLC., based in Miami, Fla. Paxil is marketed by GlaxoSmithKline, based in Philadelphia, Pa.  

 

For more information:

 

FDA Approved Drugs: Questions and Answers

 

NIH: Menopause

USP Monograph Modernization Program

The FDA recognizes that there is an ongoing need to update and modernize the methods contained in the United States Pharmacopeia – National Formulary (USP-NF). In this respect, the FDA, with representation across the Agency, has established a Monograph Modernization Working Group that interfaces with the USP Monograph Modernization Program.

The direct participation of the pharmaceutical industry, and other interested stakeholders, in USP’s Monograph Modernization Program is encouraged to assist in providing updated public standards vital to strengthen efforts for both FDA and USP to protect the public health. Paramount to this effort is the submission of updated analytical methodology pertinent to a compendial article, as well as materials which could be used for independent validation. FDA encourages all stakeholders to fully support this effort.

 

Further information to become an active participant in this process is available on USP’s website at http://www.usp.org/usp-nf/development-process/monograph-modernization. Additionally, information, to include periodic status reports on this effort, is available at http://www.usp.org/usp-nf/key-issues/monograph-modernization. (From USFDA)

PUBLIC HEALTH WARNING AGAINST RECEIVING UNAPPROVED STEM CELL PREPARATIONS IN NON-HEALTH FACILITIES

FDA Advisory No. 2013-012

The FDA has been receiving complaints from the public and health professionals that stem cell therapies are conducted in non-health facilities, such as hotel rooms.

The public is warned against receiving stem cell preparations and therapies without prior regulatory applications and approval from the Food and Drug Administration, Department of Health.  The following stem cell preparations require FDA approval: a) genetically altered human adult and umbilical cord stem cells, b) adipose or fat cells derived human stem cell, c) human cells, tissues, and cellular and tissue-based products that are subjected to genetic manipulation, and d) live animal embryonic, fetal, or adult stem cells in parenteral form for human administration.  The public is further warned that FDA-DOH does not allow the creation, importation, promotion, marketing and use of human embryos, human embryonic stem cells and their derivatives, aborted human fetal stem cells and their derivatives for human treatment and research, as well as plant parts labeled as stem cells.

Patients who might receive stem cell preparations and  therapy without prior FDA-DOH approval run the risks of contracting infectious diseases and severe complications which may lead to permanent disabilities, physical deformities, serious iatrogenic harm, autoimmune diseases and worst death, and without the benefit of health insurance coverage.

All patients are advised to consult only with duly-licenses medical practitioners who practice stem cell therapy in health facilities that are approved by the DOH.  Moreover, patients are highly encouraged to verify with the FDA, Philippines, before undergoing the procedures using our info@fda.gov.ph.  This health warning and advice extend to all tourists who visit the Philippines for their leisure needs as well as medical needs.

In case of adverse event or complaints use our eReport facility at www.fda.gov.ph

FDA Philippines: Ensuring Access of Filipino People to Safe, Effective and Affordable Essential Medicines and the Pharmacy Law of the Philippines

The FDA is concerned over the statement made by the Philippine Pharmacists Association (PPhA) and the Drugstores Association of the Philippines (DAP) last 13 April 2013 that warned the public over drugstores that employ "ghost pharmacists", referring to absentee registered pharmacists employed by unscrupulous drugstore owners. The statement made by PPhA EVP, Dr. Yolanda Robles, that around 70% of the owners in the CAMANAVA area have no pharmacists is alarming. The FDA would like to assure the public that the FDA shall continue to make sure that safe and effective medicines are available to consumers in the CAMANAVA area and the rest of the country. The FDA further informs the public that it has initiated series of activities to address "ghost pharmacies" and acute shortage of dedicated community pharmacists that have severely affected the DOH delivery of public health goods and services and health outcomes.

To see the full Advisory please click here: FDA Advisory No. 2013-011

Excerpt from FDA Philippines

Hypertension and Drug Therapy

Hypertension – is an elevation of the blood pressure necessary to perfuse tissue and organs. Elevated systemic blood pressure is usually defined as a systolic reading greater than or equal to 140 mm Hg and a diastolic reading greater than or equal to 90 mm Hg.

Etiology

A specific cause of hypertension can be established in only 10-15% of patients. It is important to consider specific causes in each case, however, because some of them are amenable to definitive surgical treatment: renal artery constriction, coarctation of the aorta, pheochromocytoma, Cushing's disease, and primary aldosteronism.

Patient in whom no specific cause of hypertension can be found are said to have essential hypertension. In most cases, elevated blood pressure is associated with an overall increase in resistance to flow of blood through arterioles, while cardiac output is usually normal. Meticulous investigation of autonomic nervous system function, baroreceptor reflexes, the renin-angiotensin-aldosterone system, and the kidney failed to identify a primary abnormality as the cause of increased peripheral vascular resistance in the essential hypertension. Elevated blood pressure is usually caused by a combination of several abnormalities.

A family history of hypertension increased the likelihood that an individual will develop hypertensive disease. Essential hypertension occurs four times more frequently among blacks than among whites, and it occurs more often among middle-aged males than among middle-aged females. Environmental factors such as stressful lifestyle, high dietary intake of sodium, obesity, and smoking all further predispose an individual to the occurrence of hypertension.

Physiology of Hypertension

Arterial blood pressure is regulated within a narrow range to provide adequate perfusion of the tissues without causing damage to the vascular system, particularly the arterial intima. Arterial blood pressure is directly proportional to the product of the cardiac output and the peripheral vascular resistance (BP = CO x PVR). In both normal and hypertensive individuals, cardiac output and peripheral resistance are controlled mainly by to overlapping control mechanisms: the baroreflexes mediated by the sympathetic nervous system, and the renin-angiotensin-aldosterone system. Most antihypertensive drugs lower blood pressure by reducing cardiac output and/or decreasing peripheral resistance.

A. Baroreceptors and the sympathetic nervous system

Baroreflexes involving the sympathetic nervous system are responsible for the rapid moment-to-moment regulation of blood pressure. A fall in blood pressure causes pressure-sensitive neurons (baroreceptors in the aortic arch and carotid sinuses) to send fewer impulses to cardiovascular centers in the spinal cord. This prompts a reflex response of increased sympathetic and decreased parasympathetic output to the heart and vasculature, resulting in vasoconstriction and increased cardiac output. These changes result in a compensatory rise in blood pressure.

B. Renin-angiotensin-aldosterone system

The kidney provides for the long-term control of blood pressure by altering the blood volume. Baroreceptors in the kidney respond to reduce arterial pressure (and to sympathetic stimulation of β-adrenoceptors) by releasing the enzyme renin. This predispose converts angiotensinogen to angiotensin I, which is in turn converted to angiotensin II in the presence of angiotensin converting enzyme (ACE). Angiotensing II is the body's most potent circulating vasocontrictor, causing an increase in blood pressure. Furthermore, angiotensin II stimulates aldosterone secretion, leading to increased renal sodium reabsorption and an increase in blood volume, which contribute to a further increase in blood pressure.

Classification of Hypertension Based on JNC 7

 

Table 4 provides a classification of BP for adults18 years and older. The classification is based on the average of two or more properly measured, seated, BP readings on each of two or more office visits.

Prehypertension is not a disease category. Rather, it is a designation chosen to identify individuals at high risk of developing hypertension, so that both patients and clinicians are alerted to this risk and encouraged to intervene and prevent or delay the disease from developing. Individuals who are prehypertensive are not candidates for drug therapy based on their level of BP and should be firmly and unambiguously advised to practice lifestyle modification in order to reduce their risk of developing hypertension in the future (see Lifestyle Modifications). Moreover, individuals with prehypertension, who also have diabetes or kidney disease, should be considered candidates for appropriate drug therapy if a trial of lifestyle modification fails to reduce their BP to 130/80 mmHg or less.

This classification does not stratify hypertensive individuals by the presence or absence of risk factors or target organ damage in order to make different treatment recommendations, should either or both be present. JNC 7 suggests that all people with hypertension (stages 1 and 2) be treated. The treatment goal for individuals with hypertension and no other compelling conditions is <140/90 mmHg. The goal for individuals with prehypertension and no compelling indications is to lower BP to normal levels with lifestyle changes, and prevent the progressive rise in BP using the recommended lifestyle modifications (see Lifestyle Modifications).

Patient Evaluation

Evaluation of hypertensive patients has three objectives: (1) to assess lifestyle and identify other cardiovascular risk factors or concomitant disorders that may affect prognosis and guide treatment (table 6); (2) to reveal identifiable causes of high BP (table 7); and (3) to assess the presence or absence of target organ damage and CVD. Patient evaluation is made through medical history, physical examination, routine laboratory tests, and other diagnostic procedures. The physical examination should include: an appropriate measurement of BP, with verification in the contralateral arm; an examination of the optic fundi; a calculation of body mass index (BMI) (measurement of waist circumference is also very useful); an auscultation for carotid, abdominal, and femoral bruits; a palpation of the thyroid gland; a thorough examination of the heart and lungs; an examination of the abdomen for enlarged kidneys, masses, distended urinary bladder, and abnormal aortic pulsation; a palpation of the lower extremities for edema and pulses; and neurological assessment.

Data from epidemiological studies and clinical trials have demonstrated that elevations in resting heart rate and reduced heart-rate variability are associated with higher cardiovascular risk. In the Framingham Heart Study, an average resting heart rate of 83 beats per minute was associated with asubstantially higher risk of death from a cardiovascular event than the risk associated with lower heart rate levels. Moreover, reduced heart-rate variability was also associated with an increase in cardiovascular mortality. No clinical trials have prospectively evaluated the impact of reduced heart rate on cardiovascular outcomes.

Laboratory Tests and Other Diagnostic Procedures

Routine laboratory tests recommended before initiating therapy include a 12-lead electrocardiogram;

urinalysis; blood glucose and hematocrit; serum potassium, creatinine (or the corresponding estimated glomerular filtration rate [eGFR]), and calcium;66 and a lipoprotein profile (after a 9- to 12-hour fast) that includes high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and triglycerides. Optional tests include measurement of urinary albumin excretion or albumin/creatinine ratio (ACR) except for those with diabetes or kidney disease where annual measurements should be made. More extensive testing for identifiable causes is not generally indicated unless BP control is not achieved or the clinical and routine laboratory evaluation strongly suggests an identifiable secondary cause (i.e., vascular bruits, symptoms of catecholamine excess, or unprovoked hypokalemia). (See Identifiable Causes of Hypertension for a more thorough discussion.)

The presence of decreased GFR or albuminuria has prognostic implications as well. Studies reveal a strong relationship between decreases in GFR and increases in cardiovascular morbidity and mortality. Even small decreases in GFR increase cardiovascular risk. Serum creatinine may overestimate glomerular filtration. The optimal tests to determine GFR are debated, but calculating GFR from the recent modifications of the Cockcroft and Gault equations is useful. The presence of albuminuria, including microalbuminuria, even in the setting of normal GFR, is also associated with an increase in cardiovascular risk. Urinary albumin excretion should be quantitated and monitored on an annual basis in high-risk groups, such as those with diabetes or renal disease.

Additionally, three emerging risk factors (1) high-sensitivity C-reactive protein (HS-CRP); a marker of inflammation; (2) homocysteine; and (3) elevated heart rate may be considered in some individuals, particularly those with CVD but without other risk-factor abnormalities. Results of an analysis of the Framingham Heart Study cohort demonstrated that those with a LDL value within the range associated with low cardiovascular risk, who also had an elevated HS-CRP value, had a higher cardiovascular event rate as compared to those with low CRP and high LDL cholesterol. Other studies also have shown that elevated CRP is associated with a higher cardiovascular event rate, especially in women. Elevations in homocysteine have also been linked higher cardiovascular risk; however, the results with this marker are not as robust as those with high HS-CRP.

Identifiable Causes of Hypertension

Additional diagnostic procedures may be indicated to identify causes of hypertension, particularly in patients whose (1) age, history, physical examination, severity of hypertension, or initial laboratory findings suggest such causes; (2) BP responds poorly to drug therapy; (3) BP begins to increase for uncertain reason after being well controlled; and (4) onset of hypertension is sudden. Screening tests for particular forms of identifiable hypertension are shown in table 8.

Pheochromocytoma should be suspected in patients with labile hypertension or with paroxysms of hypertension accompanied by headache, palpitations, pallor, and perspiration. Decreased pressure in the lower extremities or delayed or absent femoral arterial pulses may indicate aortic coarctation; and truncal obesity, glucose intolerance, and purple striae suggest Cushing’s syndrome. Examples of clues from the laboratory tests include unprovoked hypokalemia (primary aldosteronism), hypercalcemia (hyperparathyroidism), and elevated creatinine or abnormal urinalysis (renal parenchymal disease). Appropriate investigations should be conducted when there is a high index of suspicion of an identifiable cause.

The most common parenchymal kidney diseases associated with hypertension are chronic glomerulonephritis, polycystic kidney disease, and hypertensive nephrosclerosis. These can generally be distinguished by the clinical setting and additional testing. For example, a renal ultrasound is useful

in diagnosing polycystic kidney disease. Renal artery stenosis and subsequent renovascular hypertension should be suspected in a number of circumstances including: (1) onset of hypertension before age 30, especially in the absence of family history, or onset of significant hypertension

after age 55; (2) an abdominal bruit especially if a diastolic component is present; (3) accelerated hypertension; (4) hypertension that had been easy to control but is now resistant; (5) recurrent flash

pulmonary edema; (6) renal failure of uncertain etiology especially in the absence of proteinuria or an abnormal urine sediment; and (7) acute renal failure precipitated by therapy with an angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) under conditions of occult bilateral renal artery stenosis or moderate to severe volume depletion.

In patients with suspected renovascular hypertension, noninvasive screening tests include the ACEI-enhanced renal scan, duplex Doppler flow studies, and magnetic resonance angiography. While renal artery angiography remains the gold standard for identifying the anatomy of the renal artery, it is not recommend for diagnosis alone because of the risk associated with the procedure. At the time of intervention, an arteriogram will be performed using limited contrast to confirm the stenosis and identify the anatomy of the renal artery.

Goals of Therapy

The ultimate public health goal of antihypertensive therapy is to reduce cardiovascular and renal morbidity and mortality. Since most persons with hypertension, especially those >50 years of age, will reach the DBP goal once the SBP goal is achieved, the primary focus should be on attaining the SBP goal. Treating SBP and DBP to targets that are <140/90 mmHg is associated with a decrease in CVD complications. In patients with hypertension and diabetes or renal disease, the BP goal is <130/80 mmHg.

Therapeutic Alternatives and Treatment

There are excellent clinical outcome trial data proving that lowering BP with several classes of drugs, including angiotensin converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), beta-blockers (Bbs), calcium channel blockers (CCBs), and thiazide-type diuretics, will all reduce the complications of hypertension. Tables 10 and 11 provide a list of commonly used antihypertensive agents.

Thiazide-type diuretics have been the basis of antihypertensive therapy in most outcome trials. In these trials, including the recently published Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT),diuretics have been virtually unsurpassed in preventing the cardiovascular complications of hypertension. The exception is the Second Australian National Blood Pressure trial which reported slightly better outcomes in White men with a regimen that began with an ACEI compared to one starting with a diuretic. Diuretics enhance the antihypertensive efficacy of multidrug regimens, can be useful in achieving BP control, and are more affordable than other antihypertensive agents. Despite these findings, diuretics remain underutilized.

Thiazide-type diuretics should be used as initial therapy for most patients with hypertension, either alone or in combination with one of the other classes (ACEIs, ARBs, BBs, CCBs) demonstrated to be beneficial in randomized controlled outcome trials. The list of compelling indications requiring the use of other antihypertensive drugs as initial therapy are listed in table 11. If a drug is not tolerated or is contraindicated, then one of the other classes proven to reduce cardiovascular events should be used instead.

 

Special Considerations

The patient with hypertension and certain comorbidities requires special attention and followup by the clinician.

Ischemic Heart Disease

Ischemic heart disease (IHD) is the most common form of target organ damage associated with hypertension. In patients with hypertension and stable angina pectoris, the first drug of choice is usually a BB; alternatively, long-acting CCBs can be used.In patients with acute coronary syndromes (unstable angina or myocardial infarction), hypertension should be treated initially with BBs and ACEIs, with addition of other drugs as needed for BP control. In patients with postmyocardial infarction, ACEIs, BBs, and aldosterone antagonists have proven to be most beneficial. Intensive lipid management and aspirin therapy are also indicated.

Heart Failure

Heart failure (HF), in the form of systolic or diastolic ventricular dysfunction, results primarily from systolic hypertension and IHD. Fastidious BP and cholesterol control are the primary preventive measures for those at high risk for HF.In asymptomatic individuals with demonstrable ventricular dysfunction, ACEIs and BBs are recommended.For those with symptomatic ventricular dysfunction or end-stage heart disease, ACEIs, BBs, ARBs and aldosterone blockers are recommended along with loop diuretics.

Diabetic Hypertension

Combinations of two or more drugs are usually needed to achieve the target goal of <130/80 mmHg.Thiazide diuretics, BBs, ACEIs, ARBs, and CCBs are beneficial in reducing CVD and stroke incidence in patients with diabetes. ACEI- or ARB-based treatments favorably affect the progression of diabetic nephropathy and reduce albuminuria, and ARBs have been shown to reduce progression to macroalbuminuria.

Chronic Kidney Disease

In people with chronic kidney disease (CKD), as defined by either (1) reduced excretory function with an estimated GFR below 60 ml/min per 1.73 m2 (corresponding approximately to a creatinine of >1.5 mg/dL in men or >1.3 mg/dL in women), or (2) the presence of albuminuria (>300 mg/day or 200 mg albumin/g creatinine), therapeutic goals are to slow deterioration of renal function and prevent CVD. Hypertension appears in the majority of these patients, and they should receive aggressive BP management, often with three or more drugs to reach target BP values of <130/80 mmHg. ACEIs and ARBs have demonstrated favorable effects on the progression of diabetic and nondiabetic renal disease. A limited rise in serum creatinine of as much as 35 percent above baseline with ACEIs or ARBs is acceptable and is not a reason to withhold treatment unless hyperkalemia develops. With advanced renal disease (estimated GFR <30 ml/min 1.73 m2, corresponding to a serum creatinine of 2.5–3 mg/dL), increasing doses of loop diuretics are usually needed in combination with other drug classes.

Cerebrovascular Disease

The risks and benefits of acute lowering of BP during an acute stroke are still unclear; control of BP at intermediate levels (approximately 160/100 mmHg) is appropriate until the condition has stabilized or improved. Recurrent stroke rates are lowered by the combination of an ACEI and thiazide-type diuretic.

Other Special Situations

Minorities

BP control rates vary in minority populations and are lowest in Mexican Americans and Native Americans.1 In general, the treatment of hypertension is similar for all demographic groups, but socioeconomic factors and lifestyle may be important barriers to BP control in some minority patients. The prevalence, severity, and impact of hypertension are increased in African Americans, who also demonstrate somewhat reduced BP responses to monotherapy with Bbs, ACEIs, or ARBs compared to diuretics or CCBs. These differential responses are largely eliminated by drug combinations that include adequate doses of a diuretic. ACEI-induced angioedema occurs 2–4 times more frequently in African American patients with hypertension than in other groups.

Obesity and the metabolic syndrome

Obesity (BMI >30 kg/m2) is an increasingly prevalent risk factor for the developmentof hypertension and CVD. The Adult Treatment Panel III guideline for cholesterol management defines the metabolic syndrome as the presence of three or more of the following conditions: abdominal obesity (waist circumference >40 inches in men or >35 inches in women), glucose intolerance (fasting glucose >110 mg/dL), BP >130/85 mmHg, high triglycerides (>150 mg/dL), or low HDL (<40 mg/dL in men or <50 mg/dL in women).66 Intensive lifestyle modification should be pursued in all individuals with the metabolic syndrome, and appropriate drug therapy should be instituted for each of its components as indicated.

Left ventricular hypertrophy

Left ventricular hypertrophy (LVH) is an independent risk factor that increases the risk of subsequent CVD. Regression of LVH occurs with aggressive BP management, including weight loss, sodium restriction, and treatment with all classes of antihypertensive agents except the direct vasodilators hydralazine, and minoxidil.

Peripheral arterial disease

Peripheral arterial disease (PAD) is equivalent in risk to IHD. Any class of antihypertensive drugs can be used in most PAD patients. Other risk factors should be managed aggressively, and aspirin should be used.

Hypertension in older persons

Hypertension occurs in more than two-thirds of individuals after age 65. This is also the population with the lowest rates of BP control. Treatment recommendations for older people with hypertension, including those who have isolated systolic hypertension, should follow the same principles outlined for the general care of hypertension. In many individuals, lower initial drug doses may be indicated to avoid symptoms; however, standard doses and multiple drugs are needed in the majority of older people to reach appropriate BP targets.

Postural hypotension

A decrease in standing SBP >10 mmHg, when associated with dizziness or fainting,is more frequent in older patients with systolic hypertension, diabetes, and those taking diuretics, venodilators (e.g., nitrates, alpha-blockers, and sildenafillike drugs), and some psychotropic drugs. BP in these individuals should also be monitored in the upright position. Caution should be used to avoid volume depletion and excessively rapid dose titration of antihypertensive drugs.

Dementia

Dementia and cognitive impairment occur more commonly in people with hypertension. Reduced progression of cognitive impairment may occur with effective antihypertensive therapy.

Hypertension in women

Oral contraceptives may increase BP, and the risk of hypertension increases with duration of use. Women taking oral contraceptives should have their BP checked regularly. Development of hypertension is a reason to consider other forms of contraception. In contrast, menopausal hormone therapy does not raise BP.

Women with hypertension who become pregnant should be followed carefully because of increased risks to mother and fetus. Methyldopa, BBs, and vasodilators are preferred medications for the safety of the fetus.72 ACEI and ARBs should not be used during pregnancy because of the potential for fetal defects and should be avoided in women who are likely to become pregnant. Preeclampsia, which occurs after the 20th week of pregnancy, is characterized by new-onset or worsening hypertension, albuminuria, and hyperuricemia, sometimes with coagulation abnormalities. In some patients, preeclampsia may develop into a hypertensive urgency or emergency and may require hospitalization, intensive monitoring, early fetal delivery, and parenteral antihypertensive and anticonvulsant therapy.

Hypertension in children and adolescents

In children and adolescents, hypertension is defined as BP that is, on repeated measurement, at the 95th percentile or greater adjusted for age, height, and gender. The fifth Korotkoff sound is used to define DBP. Clinicians should be alert to the possibility of identifiable causes of hypertension in younger children (i.e., kidney disease, coarctation of the aorta). Lifestyle interventions are strongly recommended, with pharmacologic therapy instituted for higher levels of BP or if there is insufficient response to lifestyle modifications. Choices of antihypertensive drugs are similar in children and adults, but effective doses for children are often smaller and should be adjusted carefully. ACEIs and ARBs should not be used in pregnant or sexually active girls. Uncomplicated hypertension should not be a reason to restrict children from participating in physical activities, particularly because long-term exercise may lower BP. Use of anabolic steroids should be strongly discouraged. Vigorous interventions also should be conducted for other existing modifiable risk factors (e.g., smoking).

Hypertensive urgencies and emergencies

Patients with marked BP elevations and acute target-organ damage (e.g., encephalopathy, myocardial infarction, unstable angina, pulmonary edema, eclampsia, stroke, head trauma, life-threatening arterial bleeding, or aortic dissection) require hospitalization and parenteral drug therapy.1 Patients with markedly elevated BP but without acute target organ damage usually do not require hospitalization, but they should receive immediate combination oral antihypertensive therapy. They should be carefully evaluated and monitored for hypertension-induced heart and kidney damage and for identifiable causes of hypertension.

Additional Considerations in Antihypertensive Drug Choices

Antihypertensive drugs can have favorable or unfavorable effects on other comorbidities.

Potential favorable effects

Thiazide-type diuretics are useful in slowing demineralization in osteoporosis. BBs can be useful in the treatment of atrial tachyarrhythmias/fibrillation, migraine, thyrotoxicosis (short term), essential tremor, or perioperative hypertension. CCBs may be useful in Raynaud’s syndrome and certain arrhythmias, and alpha-blockers may be useful in prostatism.

Potential unfavorable effects

Thiazide diuretics should be used cautiously in patients who have gout or who have a history of significant hyponatremia. BBs should generally be avoided in individuals who have asthma, reactive airways disease, or second or third degree heart block. ACEIs and ARBs should not be given to women likely to become pregnant and are contraindicated in those who are. ACEIs should not be used in individuals with a history of angioedema. Aldosterone antagonists and potassium-sparing diuretics can cause hyperkalemia and should generally be avoided in patients who have serum potassium values more than 5.0 mEq/L while not taking medications.

Lifestyle Modifications

Adoption of healthy lifestyles by all persons is critical for the prevention of high BP and is an indispensable part of the management of those with hypertension. Weight loss of as little as 10 lbs (4.5 kg) reduces BP and/or prevents hypertension in a large proportion of overweight persons, although the ideal is to maintain normal body weight. BP is also benefited by adoption of the Dietary Approaches to Stop Hypertension (DASH) eating plan which is a diet rich in fruits, vegetables, and lowfat dairy products with a reduced content of dietary cholesterol as well as saturated and total fat (modification of whole diet). It is rich in potassium and calcium content. Dietary sodium should be reduced to no more than 100 mmol per day (2.4 g of sodium). Everyone who is able should engage in regular aerobic physical activity such as brisk walking at least 30 minutes per day most days of the week. Alcohol intake should be limited to no more than 1 oz (30 mL) of ethanol, the equivalent of two drinks per day in most men and no more than 0.5 oz of ethanol (one drink) per day in women and lighter weight persons. A drink is 12 oz of beer, 5 oz of wine, and 1.5 oz of 80- proof liquor (see table 9). Lifestyle modifications reduce BP, prevent or delay the incidence of hypertension, enhance antihypertensive drug efficacy, and decrease cardiovascular risk. For example, in some individuals, a 1,600 mg sodium DASH eating plan has BP effects similar to single drug therapy. Combinations of two (or more) lifestyle modifications can achieve even better results. For overall cardiovascular risk reduction, patients should be strongly counseled to quit smoking.

 

Followup and Monitoring

Once antihypertensive drug therapy is initiated, most patients should return for followup and adjustment of medications at monthly intervals or until the BP goal is reached. More frequent visits will be necessary for patients with stage 2 hypertension or with complicating comorbid conditions. Serum potassium and creatinine should be monitored at least one to two times per year. After BP is at goal and stable, followup visits can usually be at 3- to 6-month intervals. Comorbidities such as HF, associated diseases such as diabetes, and the need for laboratory tests influence the frequency of visits. Other cardiovascular risk factors should be monitored and treated to their respective goals, and tobacco avoidance must be promoted vigorously. Low-dose aspirin therapy should be considered only when BP is controlled because of the increased risk of hemorrhagic stroke when the hypertension is not controlled.

Public Health Challenges and Community Programs

Public health approaches, such as reducing calories, saturated fat, and salt in processed foods and increasing community/school opportunities for physical activity, can achieve a downward shift in the distribution of a population’s BP, thus potentially reducing morbidity, mortality, and the lifetime risk of an individual’s becoming hypertensive. This becomes especially critical as the increase in BMI of Americans has reached epidemic levels. Now, 122 million adults are overweight or obese, which contributes to the rise in BP and related conditions. The JNC 7 endorses the American Public Health Association resolution that the food manufacturers and restaurants reduce sodium in the food supply by 50 percent over the next decade. When public health intervention strategies address the diversity of racial, ethnic, cultural, linguistic, religious, and social factors in the delivery of their services, the likelihood of their acceptance by the community increases. These public health approaches can provide an attractive opportunity to interrupt and prevent the continuing costly cycle of managing hypertension and its complications.

N.B. The content is excerpt from The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. For complete information visit NHLBI

Web site http://www.nhlbi.nih.gov/.