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Up to 20% of Drugs May Cause Unexpected Problems

Up to one fifth of all new prescription drugs may ultimately be recalled or produce potentially harmful side effects, a recent study concludes.

"The safety of new agents cannot be known with certainty until a drug has been on the market for many years," according to the lead researcher.

The study results are based on an evaluation of the 548 drugs that were first marketed between 1975 and 1999. The researchers looked up all drug recalls and scanned the Physician's Desk Reference, a commonly used source of drug information, for new warnings on side effects. During the study period, 10% of new drugs either received new warnings or were withdrawn, with half of those developments occurring within 7 years after the drug first appeared on the market. Based on these results, it was calculated that a new drug has a 20% chance of being withdrawn or producing previously unknown side effects over a 25-year period.

Side effects from new drugs can have a widespread impact. Almost 20 million Americans took one or more of the five drugs that were withdrawn between September 1997 and September 1998.

They found that 56 of 548 new drugs approved by the agency during the 25-year period were later subjected to so-called "black box" safety warnings or banned from the market altogether. FDA uses "black box" warnings on drug labels to warn physicians of potentially dangerous side effects or drug interactions.

In some cases, those side effects can be deadly: Since 1993, seven drugs that were approved (then later withdrawn) may have contributed to over 1,000 deaths.

A total of 81 major label changes or drug withdrawals occurred during the study period.

Several high-profile drugs have been pulled from the market by regulators over the last few years. One drug, the antihistamine terfenadine (Seldane), spent nearly 13 years on the market before being banned in 1998. Another, the gastrointestinal drug cisapride, was available for over 6 years. Both drugs were pulled because researchers discovered high rates of heart toxicity associated with their use.

The researchers believe that fewer than 1 in 10 adverse drug reactions are reported to the FDA. New drugs may be causing more harm than this study illustrates. "Our study is definitely an underestimate of what is going on," Dr. Karen E. Lasser said. Drugs that are withdrawn or cause previously unknown side effects after being approved were clearly not properly evaluated, she said.

If you are on medications, or plan to take a new one, we advise you to consult with one of our physicians. We have an array of alternative therapies that you may be able to utilize to achieve the same result as a drug, but without the side effects.

Source: Journal of the American Medical Association 2002;287:2215-2220, 2273-2275