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Prescription for trouble: common drugs, hidden dangers. Tens of millions of people at risk.(risk factor of prescription drugs)
U.S. consumers have been buffeted by bad news about the safety of the prescription drugs they take. One shock was the revelation of serious heart risks from the pain reliever Vioxx. Then "black box"warnings about an increased risk of suicide in young people were slapped on all antidepressants.
A leader of the Food and Drug Administration's drug-safety office has told Congress that the agency and its once-vaunted Center for Drug Evaluation and Research are "broken." The FDA is currently the object of several investigations, including one initiated at its own request.
A CONSUMER REPORTS investigation has now found that tens of millions of people may unknowingly have been exposed to the rare but serious side effects of a dozen relatively common prescription-drug types. Collectively, the drugs, sold in 140 brand-name or generic versions, accounted for some 266 million prescriptions in the U.S. and almost $25 billion in sales during the 12 months ending in September 2005, according to NDCHealth, an Atlanta-based health-care-information company.
Almost all of the drugs are used to treat relatively common conditions that are not usually crippling or life-threatening, such as acne, eczema, and head lice. None is the only drug option. Among the 12, which are made by a wide range of manufacturers, are the pain reliever celecoxib (Celebrex), a close cousin of Vioxx, linked with heart attack and stroke; the cholesterol reducer rosuvastatin (Crestor), which may cause muscle breakdown and kidney damage; and the eczema drugs pimecrolimus (Elidel) and tacrolimus (Protopic), which may increase the risk of cancer. (For a complete list and guidance on what to do if you take one of the 12 types, see page 39.)
The 12 drug types we have identified are not a "dirty dozen." There are plenty of others with worse risks, such as those used to treat cancer or severe rheumatoid arthritis. And each of the 12 types has legitimate medical uses, especially when other treatments fail.
But their known or possible adverse effects--which include heart attack, stroke, kidney failure, irreversible bone loss, and cancer--were undetected or underestimated when the FDA approved them for use. Some still don't carry a black-box warning--the most serious label alert--that our chief medical adviser says they should.
Even a perfect drug-safety system might miss some of the adverse effects of medicines before they hit the market. But our investigation has identified serious flaws in both the initial drug-approval process and the monitoring of products after they reach the market, which have almost surely delayed the detection and public disclosure of adverse reactions of many widely sold medications. Indeed, our investigation suggests that our list of 12 is not exhaustive.
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