The problem of undeclared and potentially dangerous drugs hiding in dietary supplements is much worse than the Food and Drug Administration’s (FDA) estimate, according to a nine-page report by the Cambridge Health Alliance released just two days after the FDA issued warning letters to companies whose products were found to contain the stimulant oxilofrine. The report, led by Dr. Pieter Cohen, an associate professor at Harvard University, reveals at least 14 manufacturers who used the oxilofrine in their sports or weight loss supplements.
Oxilofrine, also known as methylsynephrine, is similar to an amphetamine in that it stimulates the heart and increases blood pressure. Oxilofrine, though, has never been approved by the FDA because it has been linked to dangerous side effects such as vomiting, agitation and cardiac arrest. It is also banned by the World Anti-Doping Agency.
In 2009, Brazilian-American cyclist Flavia Oliveira tested positive for the drug, which got her suspended from the sport. Oliveira testified in court that she had no idea that the stimulant was hidden in the supplement she was using, “Hyperdrive 3.0+.” She was later granted a reduced sentence of 18 months. Since 2009, at least six athletes have tested positive for oxilofrine and have claimed never having knowledge that the illegal drug was in their dietary supplement.
Reports of dietary supplements containing undeclared, illegal and oftentimes dangerous ingredients prompted Cohen and his team to see how many supplements contained oxilofrine. They searched the National Institute of Health’s Dietary Supplement Label Database and found 57 products that reported containing “methylsynephrine.” Many were no longer on the market and others were unavailable. They did find 27 of them to test and found 14 to contain the drug. Of those, less than one-sixth listed the amount of the drug present, most of which were inaccurate.
Cohen says the study points to just how little oversight the FDA has with dietary supplements. “The only way to remedy the situation is to require that products are registered with the FDA before they are sold,” he recommended.
A separate study published in the New England journal of Medicine found that 23,000 Americans are sent to emergency rooms each year due to adverse events caused by dietary supplements. Products promoting athletic performance and weight loss were the biggest culprits.