Consumers and Family Members Have Opportunity to Directly Report Adverse Medication Reactions to the FDA
For Immediate Release, 22 Feb 00
Contact: Chris Marshall
MedWatch, an initiative of the Food and Drug Administration (FDA), is a program designed for reporting serious reactions and problems with medical products, such as drugs and medical devices, after they are approved and released for public use and as they are used in clinical practice. MedWatch facilitates timely identification of significant health concerns connected with these products to ensure that new safety information is quickly disseminated to the medical community and results in improved patient care. MedWatch invites the participation of consumers, health professionals, and manufacturers to make these reports over the internet, by phone or mail.
NAMI is concerned that the consumer voice is not being widely heard in this process. MedWatch provides a mechanism to directly include the experiences of consumers for ongoing evaluations by the FDA on the safety and effectiveness of medications.
Laws already in place require prescription drug manufacturers to submit to the FDA Postmarketing Adverse Drug Experience reports. Once new medications are available to the public, the pharmaceutical manufacturers are instructed to file reports including information they receive about the safety and efficacy of the new medications. There are also regulations mandating some reporting within user facilities, such as hospitals and nursing homes, on deaths and serious injuries that result from the use of medical devices. However, provider and consumer reporting of adverse effects and product problems with medications is strictly voluntary. MedWatch provides a format for reporting adverse drug reactions by consumers and health care professionals directly to the FDA, which has the authority to take actions to protect the public.
MedWatch defines an event as a "serious reaction" if the product caused death, a life-threatening situation, hospital admission or extended stay, a permanent disability, birth-defect or the need for medical intervention to prevent permanent damage. The FDA uses reports from health care professionals and manufacturers to expose problems with products already on the market and to take corrective action if necessary. In reaction to previous reports, the FDA has used its authority to make labeling changes, added boxed warnings to labels of products, and in the most serious cases, authorized product recalls and withdrawals from the market.
If you experience a serious, unexpected adverse event that you believe may be related to one or more medications you are taking, you can report this via MedWatch.
MedWatch can be accessed on the web by going to http://www.fda.gov/medwatch/index.html
To report your adverse effects or problems by phone, call the FDA Office of Emergency Operations at (301) 443-1240.
If you have additional questions about the medical product which caused your problem, or if you need additional MedWatch reporting forms, please call the FDA Office of Consumer Affairs at (800) 532-4440.
The FDA stresses that strict confidentiality practices are in place to protect those who wish to remain anonymous when reporting.