Consumers Find Weakness In FDA Approved Medications

Tens of millions of people may have been unknowingly exposed to the rare but serious side effects of 12 relatively common prescription drug types – several used regularly by many senior citizens. Consumer Reports says in its investigative report that the risk include an increased likelihood of heart attack, stroke, cancer, or suicidal tendencies but were undetected or underestimated when the drugs were approved by the Food and Drug Administration (FDA).
The risks still may not be apparent to some people, reports CR, since many of these drugs have been advertised directly to consumers and only some carry a “black box” warning, which is the FDA’s most serious label alert. The story is in the January issue of CR.
CR’s investigation suggests that its list of 12 is not exhaustive. Even a perfect drug-safety system might miss some of the less common adverse effects of medicines before they hit the market. But serious flaws in both the drug-approval process and the monitoring of products after they reach the market compound the overall problem. Despite recent signs of improvement at the FDA, extensive reforms are needed.
Almost all of the 12 drug types are used to treat common conditions that are not usually life threatening, such as acne, eczema, and head lice.
Each of the 12 types has legitimate medical uses, especially when other treatments fail.
“But the potential risks are sufficiently serious that until more is known, these drugs should be prescribed only when other options have failed, should be avoided by people whose medical conditions make them especially vulnerable to harmful reactions, or should be used only with careful monitoring for adverse reactions,” said Dr. Marvin M. Lipman, Consumers Union’s Chief Medical Adviser.
The 12 drugs include:
● Celecoxib (Celebrex), a pain reliever; ● Estrogen alone (Premarin and others) or with progestin (Prempro and others) to treat symptoms of menopause; ● Isotretinoin (Accutane) for severe acne; ● Malathion (Ovide) for head lice; ● Medroxyprogesterone injections (Depo-Provera), a contraceptive; ● Mefloquine (Lariam) to prevent malaria; ● Rosuvastatin (Crestor) for high cholesterol; ● Salmeterol* (Serevent) for asthma; ● Sibutramine (Meridia) for weight loss; SSRIs such as sertraline (Zoloft), and other antidepressants such as venlafaxine (Effexor), particularly when prescribed to young people; ● Tegaserod (Zelnorm) for irritable bowel syndrome with constipation; and ● topical immunosuppressants pimecrolimus (Elidel) and tacrolimus (Protopic) for eczema.
The nation’s drug-safety system has extensive weaknesses that put users of prescription medicines at risk.
These include:
• Rush to approve: Working under tight deadlines and with sometimes skimpy, unrepresentative data, the FDA reviews drugs at a pace that may make sound decisions difficult. Some FDA reviewers say that their bosses have pushed them to approve medications despite their reservations about safety.
• A powerless FDA: The agency lacks the effective power to force companies to complete studies after drug approval, compel doctors to report adverse reactions, or dictate new warning labels. The agency’s regulatory might also has been undercut by limited resources, dependency on drug company fees to help finance the review process, and what critics claim is a lack of will to enforce tough requirements.
• Risks hidden: Some companies have withheld studies showing unexpected risks or poor efficacy.
• What Consumers Can Do: Until adequate reforms occur, the following guidelines can help you protect yourself:
> In general, if you’re taking any of the 12 high-risk types, don’t just stop. Ask your doctor whether the benefits outweigh the risks in your case and whether other options can achieve adequate results.
> Don’t let the direct-to-consumer advertising for a medication move you to pressure your doctor to prescribe a drug, particularly a new one, unless other options haven’t helped and there’s strong evidence that you need it.
> For any new drug, ask whether studies show that it’s more effective and apparently safer than older options. If not, older ones with longer track records may be a better bet. Older drugs also tend to cost less.
> Ask your doctor or pharmacist for a list of the drug’s known adverse effects.
> Report any serious drug reactions to your doctor, or print the form from the FDA’s Web site, www.fda.gov/medwatch/report/consumer/consumer.htm, and bring it to the doctor or file it yourself.
The full report is available free at www.ConsumerReports.org. Consumer Reports Medical Guide features a free related story at http://www.consumerreports.org/crmg/risks_benefits.htm. An additional source of information for drug safety and effectiveness is www.CRBestBuyDrugs.org.
CR Note: After we went to press, the FDA requested that makers of Serevent Diskus Advair Diskus, and Foradil Aerolizer add new label warnings and issue patient information stating that, when used for asthma, these drugs “may increase the chance of severe asthma episodes, and death when those episodes occur.” (For more information, go to the FDA’s Web site, www.fda.gov/cder/drug/advisory/LABA.htm.)
The January 2006 issue of Consumer Reports is on newsstands. To subscribe, call 1-800-765-1845.
Consumer Reports is published by Consumers Union, which describes itself as "an expert, independent nonprofit organization whose mission is to work for a fair, just, and safe marketplace for all consumers and to empower consumers to protect themselves. To achieve this mission, we test, inform, and protect. To maintain our independence and impartiality, CU accepts no outside advertising, no free test samples, and has no agenda other than the interests of consumers. CU supports itself through the sale of our information products and services, individual contributions, and a few noncommercial grants."