LSRO Releases AER Report

BETHESDA, Md. The Life Sciences Research Office (LSRO) released a report, Recommendations for Adverse Event Monitoring Programs for Dietary Supplements, after conducting a two-phase study funded by Metabolife International. The company asked LSRO to determine how a system for handling consumer inquires on adverse events could be tailored to monitor the safety of dietary supplements.

LSRO conducted a review of postmarket surveillance reports and of postmarket surveillance programs used for other products regulated by the Food and Drug Administration (FDA).

According to LSRO, an effective postmarket surveillance program could enhance the likelihood of identifying true adverse events.

Recommendations for such a program included making it available to consumers 24 hours a day, creating a standardized questionnaire to facilitate data collection and ensure adverse events could be prioritized, and suggestions for addressing risk management and quality assurance.