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FDA sends Warning Letter about supplements with steroids

Jenny Decker RN's picture
Tren Xtreme supplements with steroids in FDA warning

Marketed as supplements with synthetic steroids, these products are considered to be alternatives to anabolic steroids by American Cellular Laboratories, Inc. This is far from the truth. The FDA recently sent a letter to the company warning that their product was not a dietary supplement and that they were using unapproved drugs that had not been reviewed for safety through the FDA for safety. Apparently, the supplements have resulted in some adverse events that involve men between the ages of 22-55. These adverse reports include serious liver injury, stroke, kidney failure, and pulmonary embolism.

The FDA warns consumers that some of the synthetic steroids include ‘TREN-Xtreme,” “MASS Xtreme,” “ESTRO Xtreme,” “AH-89-Xtreme,” “HMG Xtreme,” ‘MMA-3 Xtreme,” “VNS-9 Xtreme,” and “TT-40-Xtreme”. Consumers should call their physicians if they are experiencing symptoms that may be related to the supplement including nausea, weakness or fatigue, fever, abdominal pain, chest pain, shortness of breath, yellowing of the skin or whites of the eyes, or brown or discolored urine. Talking to a healthcare provider before starting any body building supplements is highly encouraged.

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Under the guise of a supplement, these synthetic steroids were sold online, by mail order, or at gyms. However, they cannot be called supplements because they do not contain any vitamins, minerals, amino acids, or herbs. The FDA warns that these drugs may contain potentially dangerous elements. Most affected by these drugs are high school athletes who find them easy and cheap to get.

Health care providers have been asked by the FDA to ask their patients about any over-the-counter products they are using, even those that may be marketed as dietary supplements. Health care providers have also been put on alert for the potential signs of adverse events from the synthetic steroids. In addition, all consumers have been urged to immediately stop taking any body building products claiming to contain the steroids or steroid-like substances.

American Cellular Laboratories has been given 15 days to respond to the warning letter from the FDA. They must outline the steps they will take to correct the problem. It is unclear what steps the FDA will take if the response is not made in regards to the synthetic steroids marketed as dietary supplements.