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Body Building Products (Marketed as Containing Steroids or Steroid-like Substances)

Audience: Consumers and all healthcare professionals

FDA notified both healthcare professionals and their patients about new safety information concerning products marketed for body building and increasing muscle mass, frequently marketed as alternatives to anabolic steroids for increasing muscle mass and strength and sold both online and in retail stores. These products are promoted to athletes to improve sports performance and to aid in recovery from training and sporting events. Although marketed as dietary supplements, they are not dietary supplements, but instead are unapproved new drugs that have not been reviewed by the FDA for safety and effectiveness.

Adverse event reports received by the FDA for body building products that are labeled to contain steroids or steroid alternatives involve men and include cases of serious liver injury, stroke, kidney failure and pulmonary embolism (blockage of an artery in the lung). Due to the potentially serious health risks associated with using these types of products, the FDA recommends that consumers immediately stop using all body building products that claim to contain steroids or steroid-like substances. Health care professionals are advised to ask their patients about any over-the-counter products they may be using, including products marketed as dietary supplements.

Health care professionals and consumers are encouraged to report any adverse events related to the use of these products to FDA’s MedWatch Adverse Event Reporting program, either online, by regular mail or by fax [link in footer below].

Read the complete MedWatch 2009 Safety summary, including links to the FDA public health advisory, news release and consumer update, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm173983.htm

You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm