A dietary supplement is said to be responsible for nearly 100 cases of hepatitis across 16 states, said a new report from Harvard Medical School experts published Thursday in the England Journal of Medicine.
OxyElite Pro, a fat-burning dietary supplement made by USPLabs, is responsible for 97 cases of hepatitis, a disease that affects the liver. A total of 47 people were hospitalized and three needed liver transplants, the report said, according to Live Science. One case resulted in the person's death.
Health experts believe the cause of the outbreak is aegeline, a new ingredient USPLabs added to the supplement, Pieter Cohen, the report's author, said according to Live Science. The ingredient was added without FDA approval. The FDA regulates supplement ingredients only after they are available on the market.
"This really points to the fact that there's no safety testing...before a new ingredient shows up in a supplement in the United States," said Cohen, who is also a general internist at the Cambridge Health Alliance, Live Science reported.
Cohen said harmful products are not removed from the marketplace until it is too late. Those who took the supplement first got sick in May 2013. But it wasn't until September of that year when doctors became aware of the hepatitis outbreak. OxyElite Pro was discontinued in October.
"Dangerous supplements remain on store shelves for weeks, months or years," Cohen said, Live Science reported.
Doctors can alert the FDA about harmful products on a website called MedWatch. But most of the reports don't make it to the FDA, Cohen said. Other products might be alerted to a poison control center. However those centers do not report to the FDA.
Cohen suggests all dietary supplements and ingredients be registered to prevent another outbreak like the hepatitis one. That way all cases will get reported, and health officials can conduct a proper investigation, Live Science reported.
Congress should also pass a law requiring all supplement ingredients be tested before they are sold, Cohen said.
"Until that happens, consumers and physicians cannot be assured that the pills, powders and potions labeled as dietary supplements are safe for human consumption," Cohen said, Live Science reported.
