A 48-year old mother of seven recently passed away after taking the dietary supplement, OxyElite Pro, for several weeks. In fact, over the past 6 months, OxyElite Pro has been linked to 24 reported cases of acute hepatitis and liver failure in Hawaii. As a result, on October 10, 2013, the Hawaii Department of Health issued a request that OxyElite Pro be voluntarily removed from stores across Hawaii. That same day, the U.S. Centers for Disease Control and Prevention (CDC) requested the product be removed from stores. According to the CDC, the most commonly reported symptoms reported include loss of appetite, fever, nausea, light-colored stools, dark urine, and jaundice.
Shortly after the Hawaii Department of Health’s request, USP Labs, LLC, the manufacturer of OxyElite Pro products based in Dallas, Texas, reported that it would cease the nationwide manufacturer and distribution of the products associated with liver failure cases. Unfortunately, that does not mean the product, meant to increase energy, concentration, and metabolism, will be pulled from shelves nationwide. Rather, it is up to the retailers who purchased the products from USP Labs whether to pull the products from the shelves.
This is not USP Labs and OxyElite Pro’s first warning from the government. In 2012, the U.S. Food and Drug Administration (FDA) warned companies, including USP Labs, to stop using the geranium extract known as DMAA after it was linked to cases of increased blood pressure, shortness of breath, chest tightening, cardiovascular problems and even heart attacks. More specifically, the FDA concluded that DMAA is not a dietary ingredient and, as such, is not eligible to be used as an active ingredient in a dietary supplement. In early 2013, USP Labs agreed to settle a DMAA class action lawsuit for $2 million. Then in April 2013, USP Labs agreed to phase out products containing DMAA.
FDA Regulation of Dietary Supplements
Unbeknownst to many consumers, unlike medicine, dietary supplements do not need FDA approval prior to being produced and sold to the public. As a result, consumers need to research before they take over the counter pills and supplements. Since dietary supplements like OxyELITE Pro are not regulated by the FDA, manufacturers can market the product using terms like “natural” and ‘pro” without properly labeling the products.
Fortunately, the Dietary Supplement Health and Education Act of 1994 (DSHEA) provides some regulation to the dietary supplement industry. The DSHEA requires that the manufacturer of a dietary supplement or dietary ingredient is responsible for ensuring that the product is sage before it is marketed. In addition, the Texas Department of State Health Services (DSHS) notes that because herbal and dietary supplement products are for the most part unregulated, consumers should educate themselves about the potential benefits and risks associated with the products. The DSHS also offers a few guidelines, including, but not limited to, the following:
• “Natural” does not necessarily mean “safe.”
• Herbal medicines can interact with OTC and prescription drugs to cause harmful effects.
• Don’t use herbs or dietary supplements if you are pregnant or nursing or give to infants or young children without consulting your doctor.
The lawyers at Carabin & Shaw are committed to informing the public of defective pharmaceutical drugs. We not only aim to obtain just compensation for our injured clients and their families, but also hope to create an economic incentive for those in the stream of commerce to produce safe products and provide sufficient warning of the dangers of their products, ultimately resulting in the saving of lives. If you or someone you know has suffered liver disease or other injuries as a result of taking OxyElite Pro, or any other dietary supplement or pharmaceutical drug, contact one of our San Antonio product liability attorneys today and we may be able to help you recover just compensation.
OxyELITE Pro Now Illegal To Sell In Hawaii, Linked To Liver Failure And Death, Huffington Post
Fat-burning supplement OxyElite pulled, linked to liver failure, by Jacque Wilson, CNN
Acute Hepatitis and Liver Failure Following the Use of a Dietary Supplement Intended for Weight Loss or Muscle Building, Centers for Disease Control and Prevention
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