Report Medication and Medical Device Problems to FDA by Smart Mobile Technology

MedWatcher is a new way to track and report side effects of drugs, medical devices, and vaccines. Do you or someone you care for take a medication, use a medical device, or have a vaccination coming up? Use MedWatcher to be up on any government safety alerts, and be aware of side effects other people have run into. You'll also have an eye on the latest news and research relating to your chosen products. If you run into a problem you believe was caused by a medication, submit a report using the Report button, and let the FDA and the rest of the MedWatcher community know about it. Your report makes a difference! It helps the community better understand the potential risks, and helps keep doctors and government officials informed as well. MedWatcher is a project out of Boston Children’s Hospital and Harvard Medical School, developed in collaboration with the FDA Center for Devices and Radiologic Health. Why Report an Event? When the FDA approves a medical product, the agency has determined that the benefits of the product outweigh the risks. “But every product that FDA approves carries some risk,” says Norman Marks, M.D., Medical Director of FDA’s MedWatch Program. “Sometimes there are risks that only come to light after a medical product gets on the market and is used in a larger number of patients, for a longer period of time, and in patients whose health characteristics are different from those of the patients studied before approval.” So continued monitoring of adverse events is essential and depends on reporting of these events to FDA so they can be entered in MedWatch. Every MedWatch report is important and is recorded in an FDA database for review and comparison to similar previous reports. When added together, reports can signal a safety problem and lead to an FDA action to protect the public, says Marks. “Reporting can help you, a family member, or someone else avoid harm, serious illness, or even death."