The Food and Drug Administration, or FDA, on Friday warned consumers against using or purchasing a vitamin B dietary supplement from Healthy Life Chemistry by Purity First, because it contains two potentially dangerous anabolic steroids that are not listed on the product’s label.
The FDA said Purity First’s B-50 supplements contain methasterone, a controlled substance, and dimethazine, both of which should not be in a dietary supplement.
“Products marketed as a vitamin but which contain undisclosed steroids pose a real danger to consumers and are illegal,” Howard Sklamberg, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, said in a statement. “The FDA is committed to ensuring that products marketed as vitamins and dietary supplements do not pose harm to consumers.”
The agency said it has received 29 reports of side effects from the consumers who used Healthy Life Chemistry by Purity First B-50 supplements, and symptoms reported ranged from fatigue, muscle cramping, and pain to abnormal laboratory findings for liver, thyroid function and cholesterol levels.
“Females who used this product reported unusual hair growth and missed menstruation, and males who used the product reported impotence and findings of low testosterone,” the FDA said in a press release, adding that the consumers who used B-50 product and experienced such symptoms should consult a health care professional and report their experience to the U.S. health regulators.
Anabolic steroids such as methasterone and dimethazine can cause acute liver injury and have serious long-term side effects in women, men and children. Consumers using products containing such steroids may be exposed to increased risk of heart attack and stroke; masculinization of women; shrinkage of the testicles; breast enlargement; infertility in males; and short stature in children, the agency warned.
Some of the cases reported required hospitalization, but there were no cases of acute liver failure or death reported, FDA said.
Farmingdale, N.Y.-based, MiraHealth Products Ltd. manufactures the B-50 supplements, which are sold online and in drugstores. The FDA said the company has declined to recall the product or warn consumers about the potentially dangerous ingredients in the product.