When a drug does serious harm, the FDA wants to hear from you

I frequently lecture to physicians, pharmacists, and other healthcare professionals on drug safety, and I often start by asking how many people have ever observed a serious adverse drug event. Almost everyone in the room raises his or her hand. I then ask how many have ever reported a serious adverse drug event to the US Food and Drug Administration (FDA) or to a drug company, and almost all of the hands go down. Often, healthcare providers do not know the important role that they can play in drug safety surveillance. Even less well known is that consumers can also contribute directly to enhancing drug safety surveillance by reporting adverse drug events that they personally have experienced.

What is a serious adverse event?

The FDA describes an adverse event as "any undesirable experience associated with the use of a medical product" (this includes medical devices as well as drugs). A serious adverse event is one that is life-threatening, requires hospitalization, results in permanent damage or disability (including birth defects), or that jeopardizes the health or life of the person using it in some other way.

The FDA's role in drug safety

The FDA is responsible for regulating many of the products we use every day, from foods and cosmetics to dietary supplements and medical devices. It is also in charge of assuring the safety and effectiveness of medicines. This includes approving prescription drugs that have been proven to work after a series of rigorous studies, as well as monitoring whether these drugs cause unforeseen problems once they are approved and used by large numbers of individuals.

One of the main tools that the FDA uses to monitor for adverse events after a drug is approved is called MedWatch: The FDA Safety Information and Adverse Event Reporting Program. Anyone, including physicians, pharmacists, nurses, and patients themselves, can go to the MedWatch website and report a suspected problem with a drug. The FDA uses a separate reporting system for adverse events related to vaccines, called the Vaccine Adverse Event Reporting System, or VAERS. These websites ask a series of questions related to the problem (e.g., what kind of problem it was, the date that it occurred, test results) and the product(s) thought to have caused the problem. Some questions require responses in order to provide the FDA some minimally necessary information, but others do not. Individuals are encouraged to provide as much specific information as they can. Individuals can also report an adverse drug event to the company that makes the drug. Drug companies are then required to send all reports of serious adverse drug events to the FDA.

What happens after you report an adverse event to the FDA?

The FDA collects and evaluates all of this information to determine whether further evaluation of particular drug products is needed. Each year, the FDA receives more than a million reports of suspected adverse drug events, but it is believed that this represents only a fraction of all of the adverse events that occur; after all, Americans fill more than 300 million prescriptions each year. Only a small portion of the reports that the FDA receives comes directly from patients.

As patients, we have the most information about adverse drug events that we experience, and are often in the best position to describe the problem and the circumstances surrounding it. The FDA's MedWatch system allows us not only to notify the FDA about problems, but it provides the FDA critical information needed to make decisions and issue communications that can help others. For example, in 2001 the cholesterol drug cerivastatin (Baycol) was removed from the market because of reports linking it to a rare condition called rhabdomyolysis, which causes injury to and breakdown of muscles and can lead to kidney failure.

In order for this system to work, the FDA needs to hear from you or your healthcare provider, either directly or through reports submitted to drug companies.