More recalls than Detroit - updates - Brief Article

Better Nutrition, Sept, 2002

A Harvard University study concludes that one in five new prescription drugs may ultimately be recalled or will produce harmful side effects.

Researchers in Cambridge, Massachusetts evaluated 548 drugs that were initially marketed between 1975 and 1999. They looked up drug recalls and scanned the Physician's Desk Reference, a commonly used source of information, for warnings on side effects.

During that time, 10 percent of new drugs either received warnings or were withdrawn--half within seven years after they first appeared on the market. Based on these results, the team calculates that each new drug has a 20 percent chance--over a 25-year period--of being withdrawn or producing unexpected side effects.

The study found that 56 of 548 new drugs approved by the US Food and Drug Administration (FDA) during the 25-year period were banned from the market altogether or subjected to so-called "black box" safety warnings--notations posted on drug labels to inform physicians of potentially dangerous side effects or interactions.

Side effects from new drugs can have widespread impact. Almost 20 million Americans took one or more of the five drugs that were withdrawn in the year between September 1997 and September 1998. In some cases, those side effects can be deadly: Since 1993, seven drugs that were approved, then later withdrawn, may have contributed to over 1,000 deaths.

Several high-profile drugs have been pulled from the market by regulators over the past few years. One drug, the antihistamine terfenadine--marketed under the name Seldane--spent nearly 13 years on the market before being banned in 1998. Another, the gastrointestinal drug cisapride, was available for over six years. Both drugs were pulled because researchers discovered high rates of heart toxicity associated with their use. The study appears in the May 1, 2002 issue of the Journal of the American Medical Association.