Julie Dohm discusses some of the adverse events that have associated with compounded drugs.

Julie Dohm focuses on regulatory matters for pharmaceutical and biotechnology companies. Between 2016 and 2019, Julie served as the lead on compounding for the U.S. Food and Drug Administration (FDA). Julie discusses some of the adverse events associated with compounded drugs.

Many serious patient illnesses and deaths linked to poor quality compounded drugs have occurred since the 2012 fungal meningitis outbreak. FDA issues compounding risk alerts to inform health care professionals, compounders and consumers about risks associated with compounded drugs, including information on adverse events, outbreaks or product quality. These are intended to alert stakeholders of the risks so that practitioners can more effectively protect patients from unsafe, ineffective and poor-quality compounded medicines.

Although compounded drugs can serve an important medical need for patients, they do not have the same safety, quality, and effectiveness assurances as FDA approved drugs. Unnecessary use of compounded drugs can needlessly expose patients to potentially serious health risks.

FDA encourages health care professionals to report adverse events and product quality defects associated with compounded drugs to FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/medwatch/report.htm

For more information drug compounding including FDA resources, visit the CheckRare drug compounding page.