How is drug safety monitored?

Pharmaceutical companies, the FDA, health care providers and patients all play important roles in monitoring drug safety. Once a new medicine is approved, the manufacturer is required to file safety reports with FDA every three months for three years, and then annually for as long as the drug is marketed. Serious and unexpected adverse events must be reported to FDA within 15 days.

In addition, FDA may request a series of long-term, follow-up studies on the medicine. The companies have dedicated teams of experienced physicians and scientists whose job is to collect and analyze safety data on a daily basis, and to immediately report any potential problems to government authorities.

FDA has a team of physicians and analysts that monitors these reports closely, gathers data from a variety of sources and looks for evidence of an unsafe product or potential safety concern. Approximately half of the Agency’s drug review resources are dedicated to evaluating both pre- and post-market drug safety.

Physicians, nurses, and other providers are on the front-line of drug safety; they are often the first to learn of a potential problem with a medicine and are obligated to report issues or concerns promptly to the FDA.

Finally, patients have a critical role to play—sometimes safety issues are not discovered in the clinical trials process but become evident once a larger number of people begin taking a drug. That is why it is imperative for patients to understand what the potential risks are of their drug, to recognize side effects, and to report them to their physician or FDA immediately.