Supplement OxyElitePro recall reveals safety gaps
FDA slow to spot and act on hazards of banned supplement once used by Canadian athlete
OxyElitePro, a popular diet supplement, was linked to one death and nearly 100 cases of severe hepatitis before it was recalled by U.S. regulators — a lag that reveals gaps in safety monitoring, a doctor argues.
The diet supplement claims to help people burn fat. By February, the U.S. Centers for Disease Control and Prevention had linked it to 97 cases of hepatitis, including 47 people who were hospitalized, three who needed liver transplants and one person who died.
It was used by Canadian wakeboarder Aaron Rathy, who was stripped of a siliver medal at the 2011 Pan American Games after he tested positive for the the stimulant methylhexaneamine.
U.S. patients began to develop severe hepatitis in May 2013 but the U.S. Food and Drug Administration didn’t learn of the cases until four months later.
The supplement was recalled in the U.S. and Health Canada sent an advisory about the U.S. reports of serious liver injury in November 2013.
"This dietary supplement was recalled, but nothing has been done to prevent another supplement from causing organ failure or death," Dr. Pieter Cohen, an assistant professor of medicine at Harvard Medical School and a general internist at Cambridge Health Alliance in Boston, wrote in this week’s New England Journal of Medicine.
Cohen gave other examples of delays between reports of side-effects and investigating why those side-effects occurred. Instead, staff at local public health agencies, the CDC or U.S. Department of Defense have often been the first to sleuth out the harm from supplements, Cohen said.
He also cited how cases of selenium poisoning linked to a poorly manufactured multivitamin were not reported on the FDA’s MedWatch online portal.
If enacted, a U.S. bill would require supplement makers to register their products with the FDA and give consumers more information about adverse events such as side-effects. Cohen applauded the regulatory step.
He said more active, real-time surveillance of reports from poison control centres could also speed up how quickly doctors, toxicologists and pharmacologists detect hazardous supplements, but lack funding.