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this pageSafety of New Drugs May Not Be Known for Many Years
WASHINGTON, D.C. — May 10, 2002 — The safety of a new drug cannot be known with certainty until it has been on the market for many years, researchers at Harvard University concluded recently in an article in the Journal of the American Medical Association. They recommended that clinicians avoid using new drugs when older, similarly effective drugs are available. Patients who must use a new drug should be informed of its limited experience and safety record, they stated.
The researchers studied “black box warnings” in the Physicians Desk Reference, which is a descriptive list of drugs approved by the federal Food and Drug Administration (FDA). The Desk Reference is a common source of information for doctors. A “black box warning” is an FDA–required, prominently displayed box that alerts practitioners to health risks that may lead to death or serious injury.
Out of 548 new drugs approved from 1975 until 2000, 56 (10.2%) acquired a new black box warning or were withdrawn from the market. Half of these withdrawals occurred within two years of the drug’s release. The study estimated that 20% of all new drugs introduced over a 25–year period will most likely cause serious or life–threatening adverse effects that are unknown or undisclosed at the time of drug approval. Common new drug problems include damage to the liver, heart and bone marrow and increased risks to pregnant women.
Dr. Wolfe, a physician with Public Citizen, a nonprofit consumer advocacy group, and one of the authors of the study, has listed other drugs that were banned since the time of the original study. These include Baycol (Cerivastatin), Raplon (Rapacuronium), and Lotronex (Alosetron). He also mentioned the severe cardiovascular problems caused by the weight reduction drug Meridia (sibutramine), which was the subject of a Public Citizen removal petition.
At Brayton Purcell, we are experienced in handling legal cases concerning prescription drug injuries. If you have a legal question about your drug exposure, please feel free to contact us.