FDA Warns of Body Building Supplements Containing Steroids

The FDA recently issued warning letters to Flex Fitness/Big Dan’s Fitness, AndroPharma, and Hardcore Formulations for illegally selling mislabeled products that contain steroid and steroid-like substances, according to a press release.

These products are intended to increase muscle mass and have been marketed as dietary supplements. The FDA warns that products being sold by the aforementioned companies are not dietary supplements, but instead are unapproved drugs that have not been reviewed for safety and efficacy.

The FDA is advising individuals to stop the use of over-the-counter body building products that contain steroid and steroid-like substances. The use of these products may result in serious liver injury, kidney injury, increased risk of heart attack and stroke, shrinkage of the testes, and male infertility, according to the release.

During a review of more than 7 years of adverse event reports for the products, the FDA discovered 35 patients who experienced liver injuries from the affected products. The FDA noted that many of these patients required hospitalization.

Individuals are advised to consult a healthcare professional if they experience symptoms linked to steroid use, including nausea, weakness, fever, abdominal pain, chest pain, shortness of breath, jaundice, or brown/discolored urine, according to the release.

The FDA advises that healthcare professionals be aware of patients displaying warning signs associated with steroid or steroid-like substances, which may include hormone-associated adverse events, such as pulmonary embolism and deep vein thrombosis.

Anyone who experiences an adverse event related to body building products that contain steroids or steroid-like substances should submit a report to the Department of Health and Human Services’ Safety Reporting Portal, the release concluded.