News, musings and commentary on dietary supplements & pharmaceutical law issues, technology, and litigation.
No advice, though.
Lawyers for consumers and injured people.(No advice on this blog, though)
Wednesday, October 09, 2013
10/9/13: OxyELITE Pro Nationwide Distribution Stopped
My office has filed a wrongful death case against the makers of OxyELITE Pro. We way that a young healthy woman died from this product, which at the time had DMAA. News this week about a nationwide story involving the new formulation of this product:
Diet supplement manufacturer USPLabs is stopping nationwide distribution of the diet pill OxyELITE Pro in lieu of a staggering number of liver failure cases associated with the supplement, Hawaii News Now reported.The announcement comes shortly after the Hawaii Department of Health requested the “voluntary removal” of OxyELITE Pro from Hawaii retailers, and asked the public to stop any use of the diet supplement. Hawaii DOH linked OxyELITE Pro to 24 recent cases of liver damage across the state, including one death.
What is in the new version of this product? Here's one label found on the web:
This is an example of a label for this product from the internet. Of course, check the label of the product you used if you have concerns. What is the first ingredient that is a concern? Yohimbe, according to several websites has several side effects:
Side effects are well recognized and may include central nervous system stimulation that causes anxiety attacks. At high doses, yohimbine is a monoamine oxidase (MAO) inhibitor. MAO inhibitors can cause serious adverse effects when taken concomitantly with tyramine-containing foods (e.g., liver, cheeses, red wine) or with over-the-counter (OTC) products containing phenylpropanolamine, such as nasal decongestants and diet aids.
Is an ingredient in the new formuation the culprit? Stay tuned. This product has made the news before. In a previous formulation, it contained DMAA.
From the FDA:
Before marketing products containing DMAA, manufacturers and distributors have a responsibility under the law to provide evidence of the safety of their products. They haven’t done that and that makes the products adulterated," said Daniel Fabricant, Ph.D., Director of FDA’s Dietary Supplement Program.
Specifically, the warning letters cite the companies for marketing products for which a notification had not been submitted for the use of DMAA as a New Dietary Ingredient (NDI). Under current law, dietary supplement manufacturers or distributors who use certain dietary ingredients not marketed in a dietary supplement prior to October 15, 1994, are responsible for notifying the FDA of evidence to support their conclusion that their dietary supplements containing NDIs are safe. Manufacturers or distributors must submit notification at least 75 days before marketing their products. The companies warned today were marketing products for which this requirement had not been met.
The FDA warning letters also advised the companies that the agency is not aware of evidence or history of use to indicate that DMAA is safe. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), manufacturers, marketers and distributors of dietary supplements are responsible for ensuring that they are marketing a safe product.
The FDA letters noted that DMAA is known to narrow the blood vessels and arteries, which can elevate blood pressure and may lead to cardiovascular events ranging from shortness of breath and tightening in the chest to heart attack. The agency has received 42 adverse event reports on products containing DMAA. While the complaints do not establish that DMAA was the cause of the incidents, some of the reports have included cardiac disorders, nervous system disorders, psychiatric disorders, and death.
Our office filed a case against USP Labs and GNC in June of 2012: