By: Jay Wattenberg
Have you ever wondered how FDA hears about side effects of drugs and other medical products once they are on the market? Or how product problems are discovered? FDA gets important reports of problems from the nation’s doctors, nurses, pharmacists, and their patients, through the MedWatch program.
MedWatch, the FDA Safety Information and Adverse Event Reporting Program, has two parts. The first is a process that seeks and accepts the voluntary reporting of serious adverse events and product quality problems into the FDA. The second part is FDA’s timely release of clinically important, product-specific safety information. MedWatch gives healthcare providers and patients access to relevant safety information to share in their decision-making about therapeutic and diagnostic choices.
MedWatch is a voluntary system, active after the product is introduced into healthcare system, and adverse event reports supplement what is known about the product beyond what was evaluated during clinical trials.
In 2011, FDA received 34,000 adverse event reports directly from doctors, other clinicians, and their patients. In addition, hundreds of thousands of reports are sent to manufacturers from these same groups of reporters and are received indirectly by the FDA each year.
Even just a few adverse event reports can be the source of a signal that may result in new information on how the product should be used or how a patient receiving the drug should be monitored. For example, a drug used to treat a serious illness was reported through MedWatch to have an effect on a patient’s heart function. This effect became evident after the patient had been receiving the drug for over two years. This patient’s case resulted in new recommendations on the doses of the product to be given to patients, and on monitoring patients taking it.
The MedWatch web page, with over one million visitors each month, is your gateway into the FDA network of information for all human medical products, including drugs, biologic products, medical devices, or dietary supplements. It is a useful reference resource for the busy clinician, providing both individual product safety alerts, and a monthly compilation of safety labeling changes for drugs and relevant biologic products in a table format, allowing for quick review.
Sign Up Today!
MedWatch offers several ways to help you stay informed about the medical products you prescribe, use, or dispense every day, by sending safety alerts directly to you, as soon as they appear on the web site.
You can sign up here for free MedWatch safety alerts and you can follow MedWatch on Twitter. And, you can also receive safety alerts by text messaging directly to your cell phone – just look for the “Wireless Alerts” option in the MedWatch E-list signup!
Jay Wattenberg is a Technical Information Specialist in FDA’s Office of Special Health Issues