Reporting Adverse Events- Drugs, Devices, Biologic(Feb 2006)

An important FDA program called "MedWatch" allows health care professionals and consumers to report serious problems that they suspect are associated with the medical products they prescribe, dispense, or use. These reports, along with follow-up investigations, can help to identify important safety concerns.

Take the example of the antibiotic Zyvox. Within the first six months of Zyvox's marketing, FDA began getting MedWatch reports of myelosupression from clinicians who suspected that the drug might be responsible. After investigating the problem, FDA worked with the manufacturer to change the Zyvox labeling to warn about the potential for myelosuppression.

Sometimes MedWatch reports highlight errors in prescribing or administering medications. For example, FDA received reports of patient injuries due to name confusion between LANOXIN, a heart medication, and what used to be called LEVOXINE, a thyroid medication. As a result, FDA asked the manufacturer to change the name of Levoxine, and now it's known as LEVOXYL, which is less likely to be confused with LANOXIN.

The MedWatch system can also help detect problems with medical products other than drugs. For example, FDA received two reports of pneumococcal eye infections in patients who'd received corneal transplants. An FDA inspection identified numerous manufacturing problems, which led the company to recall the implants.

Of course, MedWatch reports alone rarely confirm a causal relationship between an adverse event and a medical product, since it may take a formal epidemiologic study to do that. Still, MedWatch reports are vital in making sure that medical products are safe, because they provide a rapid signal to FDA that problems may be occurring.

It's important to keep the MedWatch system working, and FDA needs your help. Here are the kinds of reports that should be submitted:

Report any serious adverse event that might be associated with a drug, biologic, medical device, or dietary supplement, particularly serious adverse events that are not listed in the product labeling. "Serious" means fatalities, hospitalizations, and medically significant events.

Report therapeutic failures - cases in which the drug or device failed to work as it should (e.g., if a patient has to switch from one brand of a drug to another because the original one was ineffective).

Report cases of use errors with medications or devices, including situations where the error may have been due to poor communication, or to ambiguities in product names, directions for use, or packaging.

Report product quality issues, such as suspected counterfeit products, defective components, potential contamination, device malfunctions and poor packaging.

FDA encourages reporting these problems to MedWatch even if you're not sure that the product was the cause. It's easy to report by internet, phone, fax, or mail.

Category:

News & Politics

Tags:

• Advere
• Events
• Drugs
• Devices
• Biologics
• Dietary
• Supplements
• FDA
• MedWatch
• Patient
• Safety