A stimulant that is not approved by the FDA and has been dubbed by some as a “replacement” for the controversial and banned weight loss drug Ephedra (ephedrine) has been found in many supplements.
The stimulant, oxilofrine, though often listed as methylsynephrine on supplement labels, is considered to have ephedrine-like properties. However, it has never been approved for human consumption in the United States, though it has been granted approval in other countries.
The inclusion of oxilofrine in supplements is of deep concern considering that the FDA banned ephedrine in 2004 amidst thousands of reports of severe adverse events after people took it, including heart attack, stroke and even death in some instances.
New research published in the journal Drug Testing and Analysis by internist Pieter Cohen, M.D., who is also an assistant professor at Harvard Medical School, and colleagues sheds light on how pervasive oxilofrine is in supplements. The team analyzed 27 brands of supplements containing methylsynephrine.
They found that 14 of those supplements contained methylsynephrine, ranging in dosages of 0.0003 to 75 mg per individual serving. Of those 14, six of them contained amounts of oxilofrine considered pharmaceutical dosages or above.
Further, if consumers followed the dosing recommendations on the label, they could ingest as much as 250 mg of oxilofrine per day.
“The potential adverse health effects of inadvertently consuming up to 250 mg of oxilofrine per day, as would be possible with supplements in our study, are entirely unknown,” the researchers wrote. “Human studies using lower dosages suggest that the increased demand on the heart muscles might lead to palpitations, arrhythmias, increased blood pressure, or other adverse events.”
If there is any good news here, it is that the FDA appears to be getting the message. On March 31, the agency issued warning lettersto 7 companies marketing 8 products containing methylsynephrine. They wrote that methylsynephrine does not meet the definition of a dietary ingredient and including it as such on labeling is misbranding.
The companies have 15 business days from receiving the letters to outline steps to bring their products into compliance with FDA regulations. If they don’t, the agency could pull their products from store shelves.