Reporting Adverse Events and Interactions

How to report adverse events to FDA MedWatch

After reviewing this history and blood work, you recognize that the most likely cause of Bill's symptoms is his supplement "Peak Sports Performance" which contains: Calcium, Ma Huang, L-Carnitine, Green tea leaf extract, Caffeine, Guarana extract, Ginseng. Remember that Ma Huang is another name for Ephedra, the stimulant. Many of the ingredients in this product contain caffeine.

Besides treating and counseling Bill, you also plan to report this adverse event to the FDA. The question is, how would you go about doing this, and who would you report to?

Click here to open and view the PowerPoint presentation on Adverse Events

In 2006, a new law called Dietary Supplement and Nonprescription Drug Consumer Protection Act was passed. This piece of legislation seeks to amend the Federal Food, Drug, and Cosmetic Act to make it mandatory for manufacturers or distributors of dietary supplements to report any serious adverse event reports to the FDA within 15 days of an event.