PRESCRIPTION FOR TROUBLE
Consumer Reports Examines Weaknesses of Current Drug-safety System
YONKERS, NY – In its January investigative report, “Prescription for Trouble,” Consumer Reports (CR) found that tens of millions of people may have been unknowingly exposed to the rare but serious side effects of 12 relatively common prescription drug types. Those risks—including an increased likelihood of heart attack, stroke, cancer, or suicidal tendencies—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, 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.
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:
What Consumers Can Do: Until adequate reforms occur, the following guidelines can help you protect yourself:
The full report is available free at www.ConsumerReports.org. Consumer Reports Medical Guide features a free related story at www.consumerreports.org/crmg/risks_benefits.htm. An additional source of information for drug safety and effectiveness is www.CRBestBuyDrugs.org.
* 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.)
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