By Andrew A. Skolnick

March 19, 2000
Edited by Virginia Baldwin Gilbert

If one or two adverse drug reactions slip through the Food and Drug Administration's reporting process, the results can be tragic for some patients.

That is especially true when the adverse reactions are rare but serious -- such as in the case of liver failure caused by medication.

All drugs have the potential to harm or kill the people they're supposed to help. A shot of penicillin can kill in minutes if the recipient is allergic to the life-saving drug. Even common aspirin can be deadly.

Clinical trials of a new drug often involve a few hundred patients and therefore may not reveal that a drug can cause serious injury or death in one patient in 10,000 or even 1,000 patients. So it is critical for researchers and drug companies to report to the FDA all suspected adverse reactions among patients in their studies.

Before allowing a drug to be marketed, the FDA requires that it be tested for efficacy and safety in a series of clinical trials.

If these studies find that the potential harm from a drug outweighs its benefits, the FDA probably won't grant approval. While that decision depends on science, the decision-making process does not take place in a vacuum.

For drugs used to treat diseases such as diabetes, which affects so many people and is difficult to treat, FDA officials often face tremendous pressure to speed up their approval process.

Often, in this "fast-track" process, cases of adverse drug effects may slip through reporting cracks, consumer advocates say.

An even bigger challenge to the FDA is tracking adverse drug reactions after the drug is on the market.

Physicians are not required by law to monitor and report adverse drug effects associated with approved drugs. Some physicians, fearing a malpractice suit, may even be reluctant to report an adverse reaction.

Prompt reporting of suspected adverse drug effects is necessary to rapidly identify health hazards associated with drugs or other medical products, the FDA says.

To encourage the monitoring and reporting of all adverse drug reactions, the FDA established a medical product reporting program called MedWatch. It does not require the reporting of the patient's identity.

Information about drug problems can be found through the FDA's MedWatch Web site:

www.fda.gov/medwatch/index.html. To report adverse drug events, call 800-332-1088.