OxyElite Linked to 100 Hepatitis Cases
According to a paper authored by Dr. Pieter Cohen, assistant professor of medicine at Harvard Medical School and general internist at Cambridge Health Alliance, the dietary supplement OxyElite Pro has been linked to nearly 100 cases of hepatitis across 16 states.
About the Hepatitis Outbreak
“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. Guess who’s the experimental animal: the consumer.” – Dr. Pieter Cohen as published by FOX News
FOX News reports that Dr. Cohen has identified 97 cases of hepatitis which are linked to OxyElite Pro. Due to the outbreak, 47 people have been hospitalized, three people have required liver transplants and one person had died.
Cases of hepatitis were first reported in Hawaii last year and while people taking the supplement began falling ill in May, the Food and Drug Administration (FDA) did not learn of the cases until September – four months later. The manufacturer of the supplement, USOLabs, stopped selling the product in October.
It is currently suspected that the illnesses were caused by an ingredient called aegeline. However, because supplements do not need FDA approval before being put on the market, the dangerous ingredient made it into consumers' hands before being detected.
Lapse in Federal Regulation
While the FDA is able to regulate and remove dangerous supplements after they reach the market, the regulator must first be made aware of potential dangers. Often, this means that the agency does not know of an issue until some consumers have already suffered.
Further, not all cases are reported to the FDA. Instead, they may be reported to poison control, which does not communicate with the FDA, or they may never get reported at all. As a result, dangerous supplements can remain on the shelf for weeks, months and even years.
This realization has led to many experts proposing that all dietary supplements be registers, and information about their use and ingredients be reported to both the FDA and poison centers. Upon a consumer experiencing an adverse reaction, the incident would then be reported to the FDA and toxicologist through the new database allowing for a faster response time.
Healthcare providers are also urging congress to require that all supplements be tested by regulators before reaching the market.