New Warnings About Plavix For Patients With Heart Disease
Plavix is prescribed for patients with heart disease to prevent dangerous blood clots that can cause heart attacks and strokes
. In order to work effectively, Plavix must be broken down by a particular liver enzyme, but the Food and Drug Administration (FDA) says that two to fourteen percent of people in the U.S. have low levels of that enzyme.
The FDA is adding its strongest warning to the label for Plavix because certain people with a genetic variation cannot metabolize Plavix, and not responding to this blood thinner puts them at greater risk for heart attacks and strokes. The likelihood of not having this liver enzyme varies by race. The FDA recommends that patients who cannot process Plavix use other blood thinners, such as aspirin.
Previously, the FDA had warned that taking Nexium or Prilosec with Plavix could cut Plavix's blood-thinning effect in half. FDA regulators said the key ingredient in these heartburn medications blocks that liver enzyme that is necessary to break down Plavix.
Medications Are Not Tested for Use by Seniors
The clinical trials that drug companies use to get FDA approval are relatively small, and narrowed down to selected patient groups. We need better monitoring of the drug reactions because adverse drug reactions don't show up until drugs are used by millions of patients in a diverse population. Drugs may react differently in women than in men, for example, and drug tests with men may not indicate that a drug is unsafe for women.
When drugs are being developed, they're rarely tested in seniors according to Dr. Robyn Tamblyn, an epidemiologist and researcher at McGill University. Tamblyn says that "When a drug is approved to come into the market, you're almost in an experimental situation when you're trying it out on people for which it was never tested."
Seniors are at greater risk of adverse drug reactions, in part, because they metabolize, and excrete drugs more slowly than younger people. Commonly prescribed sleeping aides (such as dalmane, librium, and valium) may be less safe for seniors because they these drugs may not wear off the next day. Medical literature says these drugs are not "well tolerated" by the elderly.
Due to a lack of knowledge about how seniors may react to drugs tested on younger populations, more than two million seniors suffer adverse reactions yearly, and as many as 200,000 die from side effects.
The lack of testing of drugs among seniors can make changing drugs more risky for older populations. This is particularly true for medications used to treat depression, high blood pressure, and Parkinson's disease.
The Physician's Desk Reference can help identify drugs that are ineffective for seniors, or put them at an unnecessarily high risk when safer alternatives are available.
FDA Monitors Medicare Medical Records for Drug Safety
In 2008, new rules gave FDA researchers access to data from the Medicare Part D prescription drug program to enable the agency to more closely monitor drug safety. Previously, the FDA had only relied on health providers and patients to report adverse drug reactions.
Now, the FDA can query the Medicare database of health information on millions of disabled Medicare beneficiaries, and seniors to actively look for adverse drug reactions. This test pilot monitoring program was just the first step, and the FDA intends to expand its monitoring to other databases in order to identify adverse drug reactions more quickly.
Medicare Advantage Plans Help with Prescription Costs
In addition to Medicare Part D, there are other plans that help pay for the cost of seniors' prescriptions. Medicare Advantage plans are a popular alternative to original Medicare and Medicare Supplement Plans. Medicare Advantage Plans can include prescription drug coverage, and may offer more benefits and lower co-payments than Medicare Part A and B.
Medicare Advantage Plans are health plan options (like an HMO or PPO) that are approved by Medicare, and offered by private companies. These plans are part of Medicare, and are sometimes called Part C or MA Plans.
Medicare pays a fixed amount for your care every month to the companies offering Medicare Advantage Plans, and these companies must follow the rules that Medicare establishes. Medicare Advantage Plans provide your Medicare health coverage, and usually your Medicare drug coverage.
by: Wiley Long
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