Vitamins from LI tainted with anabolic steroids
At least 29 people were sickened and one hospitalized in what has grown into a nationwide federal alert involving vitamin tablets laced with potentially dangerous anabolic steroids. The product is manufactured by a Farmingdale company.
The unfolding medical drama could result in more cases, federal experts say, should other consumers link their symptoms to the product.
The tainted vitamins are marketed as Healthy Life Chemistry By Purity First B-50.
The U.S. Food and Drug Administration has asked the manufacturer -- Mira Health Products Ltd -- to voluntarily recall the product, but the company has refused. The vitamins are sold in retail outlets and over the Internet.
The refusal, FDA officials said Wednesday, could result in seizure and sanctions against the company.
A man who answered the phone at Mira Health Products would not identify himself and refused to answer questions.
An FDA lab analysis revealed the vitamins contain dimethazine and methasterone, a controlled substance. Methasterone is highly potent and a so-called designer anabolic steroid first synthesized in the 1950s.
Body builders illegally use anabolic steroids to increase muscle mass.
"Products marketed as a vitamin but which contain undisclosed steroids pose a real danger to consumers and are illegal," Howard Sklamberg, director of the FDA's Office of Compliance, said in a statement.
Discovery of the contaminated vitamins began as a medical mystery in February when patients began trickling into North Shore University Hospital in Manhasset.
Doctors initially suspected possible environmental contamination and patients were referred to Dr. Ken Spaeth, director of occupational and environmental medicine at the North Shore-Long Island Jewish Health System.
But Spaeth said after questioning patients it was clear they had come not only from Long Island but from throughout the tri-state area, with a few from as far away as Florida. The widespread geography dashed the environmental theory.
Spaeth said he became a medical Sherlock Holmes in an attempt to ferret out what ailed the patients, some only in their teens.
"People come in and part of what you're trying to do is be a detective and figure out what the problem is," Spaeth said.
His questions led to all having consumed the B-50 vitamins.
One of the patients, who asked to remain anonymous, said the vitamins had been prescribed by a Farmingdale chiropractor.
That practitioner's phone was out of order Wednesday.
Spaeth said women who had taken them reported facial hair growth and missed menstrual periods. Men reported impotence. Lab tests revealed dramatically low levels of testosterone, Spaeth said.
Using products containing anabolic steroids can cause acute liver failure. No liver injuries have been reported to date, according to the FDA.
Additionally, anabolic steroids can cause other serious long-term consequences, such as adverse effects on cholesterol levels, and increased risk of heart attack and stroke. Men may experience testicular shrinkage, breast enlargement and infertility. Children's growth may be stunted.
Federal investigators say consumers experiencing any of these symptoms should consult a health care professional and report their symptoms to the FDA.
Vitamins and other dietary supplements are not regulated with the same tight controls required of prescription drugs.
Dr. Arthur Grollman of Stony Brook University School of Medicine has been calling for stronger supplement regulations.
"Steroids have been turning up in all sorts of supplements, especially those that appeal to young people," Grollman said.
Between 2008 and 2011, the FDA received 6,307 reports of health problems related to dietary supplements.Dr. Sidney Wolfe of the consumer watchdog organization Public Citizen's Health Research Group, said supplements should be regulated under the same rules for over-the-counter drugs.
"Dietary supplements are implicitly, if not explicitly, making medical claims," Wolfe said. "They should be held to the same standards as drugs."