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Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

OxyElite Pro Now Linked to 97 Cases of Hepatitis

Posted in FDA Regulation, Public Health, Safety Alerts

Though the diet supplement OxyElite Pro was recalled last year due to a connection with liver damage and acute liver failure, more people continue to get sick, according to a recent report by Scientific American.

Currently, at least 97 people have suffered severe hepatitis in connection with OxyElite Pro, and one person has died.  The first reports of liver damage linked to OxyElite Pro came to light in May 2013, but the FDA was not aware of this until September of that year.  Several months later, the manufacturer of OxyElite, USPLabs, issued a voluntary recall.

Scientists now believe that the questionable OxyElite ingredient, aegeline, is responsible for these cases of hepatitis, and the FDA has ordered USPLabs to discontinue its use.

Dr. Pieter Cohen of Harvard University published an article in The New England Journal of Medicine on this topic topic and explains that the hepatitis cases linked to OxyElite Pro are merely emblematic of a larger problem: the safety and efficacy of dietary supplements are not regulated by the FDA before products hit the shelves.

Cohen writes “The FDA’s delayed response — with its life-threatening consequences — is attributable to our woefully inadequate system for monitoring supplement safety. Americans spend more than $32 billion a year on more than 85,000 different combinations of vitamins, minerals, botanicals, amino acids, probiotics, and other supplement ingredients. Unlike prescription medications, supplements do not require premarketing approval before they reach store shelves. Under the Dietary Supplement Health and Education Act of 1994, anything labeled as a dietary supplement is assumed to be safe until proven otherwise. The FDA is charged with the unenviable task of identifying and removing dangerous supplements only after they have caused harm.”

He explains that in 2013 alone, his colleagues and FDA researchers identified two novel analogues of methamphetamine present in products currently available to consumers. One analogue was present in a sports drink, and the other analogue was present in nine dietary supplements.  By law, none of these products were to be reviewed ad hoc by the FDA, a loophole in effect making lab animals out of consumers.

Though a US Senate bill sponsored by Dick Durbin (D-IL) and Richard Blumenthal (D-CT) is currently under review by committee that would ensure proper labeling of “vitamins, minerals, botanicals, probiotics, and other supplement ingredients,” Dr. Cohen states that this “would not improve the FDA’s ability to detect and remove dangerous supplements from store shelves.”

What is required is a more broadened reform of the approval processes for dietary supplements and other such products.  It seems clear and obvious that anything consumed in our country should undergo rigorous testing before it becomes available on the market, particularly if a product advertises health benefits.  While this could lengthen the time it takes before products may be sold and increase costs, any financial burden or wait time would be well worth the benefit of a more protected America.