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Reporting Drug Side Effects?

September 1999

Throughout the history of HIV disease, people have been making decisions about treatments with very little information about both the effectiveness and the side effects, particularly long-term side effects, associated with new medications. At the time the first anti-HIV drug, AZT (zidovudine, Retrovir®), was approved for wide-scale use, it had only been tested in few thousand people who were on the drug for six months or less. Little was even known about the proper dose of the drug. Most of what is currently known about the effectiveness, long-term side effects and optimal use of AZT was learned in later years after the drug was first approved. Since AZT and newer drugs for HIV were so desperately needed, waiting for the results of true long-term studies has never been feasible. This will undoubtedly continue to be true of most drugs used for the treatment of HIV disease as well as many drugs used to treat and manage opportunistic infections associated with HIV disease. Additionally, because women are often under-represented in studies of therapies, there is little known about serious side effects that may be unique to women when a drug is approved.

The only way that information on rare, unusual or long-term side effects of drugs can be gathered is if health care providers report information about such side effects to the Food and Drug Administration (FDA). To try to capture information on the rate of serious side effects associated with drugs, the FDA has a system in place called MedWatch. The success of the MedWatch system, however, is entirely dependent on physicians or other health care providers filling out the MedWatch form and sending it to the FDA. In cases where a doctor or health care provider is too busy to fill out the paperwork, or other circumstances prevent a doctor from doing so (e.g. you don't want the event reported by your doctor), you may file a report yourself.

Your doctor can obtain the MedWatch Voluntary Reporting Form by calling the MedWatch office at 1-800-332-1088. The one page form is simple and only takes a few moments to fill out. It can be submitted to the FDA by mail or through a toll-free fax number. Additionally, for those with access to the world wide web (internet), a form can be filled out online https://www.accessdata.fda.gov/medwatch/medwatch-online.htm

Online reporting can also be accessed by clicking the MedWatch button on the FDA's homepage http://www.fda.gov

Project Inform has sample copies of the MedWatch Voluntary Reporting Form available through the Project Inform hotline (1-800-822-7422).


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