FDA warns of dangerous steroids in vitamin supplement
On Friday, the Food and Drug Administration (FDA) issued a warning that consumers should not use or purchase a vitamin B dietary supplement because it contains two potentially dangerous anabolic steroids.
The supplement, Healthy Life Chemistry By Purity First B-50, tested positive for methasterone and dimethazine, which are steroids that have been used illegally by some bodybuilders and are not listed on the vitamin’s label.
“Products marketed as a vitamin, but which contain undisclosed steroids pose a real danger to consumers and are illegal,” said Howard Sklamberg, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “The FDA is committed to ensuring that products marketed as vitamins and dietary supplements do not pose harm to consumers.”
So far, the FDA has received 29 reports of side effects connected with the B-50 supplement. Symptoms include fatigue, muscle cramping and myalgia (muscle pain), as well as abnormal laboratory findings for liver and thyroid function, and cholesterol levels. The agency says that the two anabolic steroids in the product are known to cause unusual hair growth in women and impotence in men. Although no deaths have been reported, some who took the supplement have had to be hospitalized.
Anabolic steroids can also cause other serious long-term consequences in women, men and children, including adverse effects on blood lipid levels; increased risk of heart attack and stroke; masculinization of women; shrinkage of the testicles; breast enlargement; infertility in males; and short stature in children.
Mira Health Products Ltd. of Farmingdale, N.Y. manufactures the product, which is sold online and in various retail stores. The company has declined a government request to voluntarily recall the Healthy Life Chemistry B-50 supplement, which the FDA says puts them at risk for criminal prosecution if they continue to sell the B-50 product.
According to the FDA, the agency was first made aware of the problem from a physician who took over treatment of 20 patients referred to him, all of whom exhibited symptoms of fatigue and muscle pain, as well as abnormal lab tests. Turns out the referring physician had previously prescribed all the patients a course of vitamin supplements, including the Healthy Life Chemistry B-50 product. The FDA then collected samples of the product, which is when the agency discovered it contained two steroids.
Health care professionals are advised to ask their patients about any dietary supplements they may be using, especially if they are exhibiting symptoms associated with the use of steroids or steroid-like substances, including liver injury, kidney failure and stroke, as well as hormone-associated adverse effects such as blood clots or pulmonary embolism (a sudden blockage in a lung artery), and deep vein thrombosis (a blood clot that forms in a vein deep in the body, often in the lower leg or thigh).
If you are having any of these adverse reactions, the FDA asks that you report them to the agency’s MedWatch program either one of two ways: 1) completing and submitting the MedWatch Online Voluntary Reporting Form (3500) online at www.fda.gov/medwatch/report.htm; or 2) downloading and completing the form, then submitting it via fax at 1-800-FDA-0178.
SOURCE: Food and Drug Administration, 1. Press Release: FDA warns consumers about health risks with Healthy Life Chemistry dietary supplement (July 26, 2013); 2. Safety Alert: Healthy Life Chemistry By Purity First B-50: FDA Health Risk Warning - Undeclared Ingredients (July 26, 2013).