Medication Monitor

Generic Name (Trade Name—Company)
June 23, 2017

Multiple generic names

(Multiple trade names—Multiple companies)
FDA issues warning about body-building products labeled to contain steroid and steroid-like substances

FDA posted warning letters to Flex Fitness/Big Dan’s FitnessAndroPharm, and Hardcore Formulations for illegally marketed products labeled to contain steroid and steroid-like substances and promoted to increase muscle mass and strength.

Although the products are marketed as dietary supplements, they are not dietary supplements, said the agency. Instead, they are unapproved drugs FDA has not reviewed for safety and effectiveness.  

FDA recommends immediately stopping use of OTC body-building products labeled or promoted to contain steroid and steroid-like substances because of the risk of serious liver injury and other adverse health consequences, including kidney injury, heart attack and stroke, shrinkage of the testes, and male infertility.

In its review of more than 7 years of adverse event reports, the agency found 35 patients who had liver injuries, many requiring hospitalization, that were associated with these types of products. 

Symptoms include nausea, weakness or fatigue, fever, abdominal pain, chest pain, shortness of breath, jaundice, and brown/discolored urine.    

Health professionals should be on the alert for patients with warning signs associated with use of steroids or steroid-like substances, including liver injury, kidney injury, stroke, and hormone-associated adverse effects such as pulmonary embolism and deep vein thrombosis.