To whom should drug recalls and adverse drug reactions be reported?

Reporting drug recalls and adverse drug reactions to the FDA is essential because the FDA is responsible for monitoring the safety and efficacy of drugs in the United States. The agency maintains a database of adverse events, ensuring that any potential risk associated with a medication is thoroughly evaluated. By reporting to the FDA, healthcare professionals contribute to a national system designed to protect public health and enhance drug safety.

The FDA relies on these reports to identify problematic drugs and can take various actions, including issuing warnings, mandating recalls, or even withdrawing a drug from the market altogether if necessary. This systematic approach allows for quick responses to emerging safety concerns, potentially preventing harm to patients.

Although other entities, such as drug manufacturers or state pharmacy boards, may also collect information about adverse reactions or recalls, reporting directly to the FDA is critical for regulatory purposes and further research into drug safety.