When the Food and Drug Administration approves a medical product, it means the agency has determined that the benefits of the product outweigh the risks. However every product the FDA approves carries some risk according to Norman Marks, M.D.,director of the FDA's MedWatch program. Sometimes there are risks that only come to light after a product gets on the market and is used in larger numbers of patients who differ from those studied before approval.

That's where MedWatch comes in. MedWatch, the FDA's safety information and adverse event reporting program, plays a critical role in the agency's postmarketing surveillance--the process of following the safety profile of medical products after they've begun to be used by consumers. Through MedWatch, a voluntary program, health professionals report serious adverse reactions and problems related to drugs, biologics, medical devices, dietary supplements, cosmetics, and infant formulas. MedWatch also accepts reports of product quality problems with drugs or devices, suspected product tampering or counterfeit drugs, medication errors due to packaging problems or name confusion, and any other unexpected problems with the product that could pose a safety risk. Once the FDA receives early signals of possible safety issues, the agency can rapidly identify problems and take appropriate actions, including broadcasting new safety information as "MedWatch alerts."

MedWatch alerts in 2003 include:

Viga Tablets: The FDA announced a voluntary recall of Viga tablets by Best Life International of Clarkston, Wash. The tablets were sold as a dietary supplement with claims to in

crease sexual performance.  The drug  was found to contain the prescription drug sildenafil,  which is not listed on the drug's label. Sildenafil is the active ingredient contained in Viagra, a prescription drug used for treatment of erectile dysfunc An unsuspecting user of Viga tablets could develop life-threatening lowering of blood pressure.

Gynecare Intergel Adhesion Prevention Solution: Gynecare Worldwide, a division of Ethicon Inc. of Somerville, N.J.,  withdrew this product and urged customers to immediately stop using the device. The product is intended to be used in gynecological surgery to reduce post-surgical adhesions. There were postmarket reports of several serious problems, including postoperative pain and the need for repeat surgeries.

Risperdal (risperidone): Janssen Pharmaceutica Products L.P. of Titusville, N.J., announced important changes to Risperdal (risperidone), a treatment for schizophrenia. The labeling was updated to include a warning of cerebrovascular problems, including stroke, in elderly people with dementia. The update is based on data from four clinical trials.

"The FDA's MedWatch program has two main goals," Marks says. First, "we  want to facilitate the reporting of problems in to the agency and  secondly, we want to get safety information out to the public. MedWatch also works with 161 "MedWatch partner" organizations to widely disseminate new safety information .The  American Pharmacists Association receives e-mail notification of MedWatch safety alerts and  sends them to over 64,000 pharmacists nationwide. FDA alerts also appear on  Pharmacist.com.
The MedWatch program is  exploring opportunities to work with large health care systems that are already collecting

adverse event and medication error reports.  Marks says, "we also work with partners like the American Association of Nurse Anesthetists to encourage their members to report to the FDA.

When the FDA receives a MedWatch report, it is entered into a powerful database that allows a safety evaluator to compare it to similar reports which  then trigger a careful investigation by the FDA and  the manufacturer. The  investigation may  result  to circulation  of safety alerts, letters to health care professionals,

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labeling changes, product withdrawals, or further postmarketing research

"We want the public to know that we depend on their reports," Marks says. "They could prompt important actions that improve the public health."

How to Report to MedWatch

· To  submit a report electronically
· Call (800) FDA-1088 to report by phone
· Fax a report to (800) FDA-0178
· Mail a report to MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.