Health officials in Hawaii are asking stores to pull the fat-burning supplement OxyElite Pro from shelves after it was linked to cases of liver failure and acute hepatitis in 29 people.
Two people have undergone liver transplants and one person has died, according to the Hawaii State Department of Health. Twenty-four others fell ill and reported using the supplement before being diagnosed.
Although Hawaii investigators advised people to discontinue use of the product, OxyElite Pro is sold nationwide. Because it was a dietary supplement, it did not have to be approved by the FDA before going on the market.
The company that produces supplement, USPlabs, is stopping domestic distribution of the OxyElite Pro with the purple top and OxyElite Pro Super Thermo Powder, out of an abundance of caution. It stands by the safety of its products.
The company also informed the FDA that counterfeit versions have been circulating nationwide. The agency is investigating whether counterfeit products are linked to any the hepatitis cases.
Earlier this year, USPlabs discontinued a product called OxyElite Pro with DMAA after the FDA stated that DMAA can cause increased blood pressure shortness of breath, chest tightening, cardiovascular problems and even heart attacks.
The FDA also stated that 11 companies had received the warning regarding DMAA and USPlabs was the only one that did not agree to stop using DMAA in supplements.
Prescription and over-the-counter medications are intended to improve your quality of life and even sustain life; they are used by millions of people worldwide. The Food and Drug Administration (FDA) is the governmental agency that oversees drug manufacturers and serves as a gatekeeper to introducing new drugs to U.S. patients. The FDA may approve a drug or device it believes to be safe, only to add warnings of potential serious side effects or completely recall the drug or device at a later time.
Despite this oversight, many people are injured and even killed by dangerous medical devices and defective drugs each year.
For more information, please contact us.
Source: CNN, "Fat-burning supplement OxyElite pulled, linked to liver failure," Oct. 9, 2013.