USPlabs claims that aegeline is a safe compound found in Indonesian trees and has been ingested by humans for hundreds of years. On the other hand, the FDA believes that OxyElite Pro and VERSA-1 could be associated with more than fifty cases of non-viral hepatitis and at least one death. A November 10th update from the FDA said that the illnesses were “potentially linked” to products with the name OxyElite Pro, according to our California defective drug attorney.
What is VERSA-1?
Versa-1 is a so-called “dietary supplement” manufactured by Texas-based USPLabs that is marketed as a muscle-building aid. The product has numerous ingredients, including Aegeline, which the manufacturer claims is a compound extracted from leaves of the Bael tree. As is the case for all “dietary supplements,” the safety and efficacy of VERSA-1 has never been established through the FDA approval process that is required for prescription medications. FDA has very little control over the marketing of supplements, even though they may be associated with serious side effects.
What is the Problem with VERSA-1?
In October of 2013, the FDA and the CDC (Centers for Disease Control and Prevention) announced and investigation into reports numerous cases of serious liver damage in Hawaii and other states involving patients ingested OxyElite Pro, which is manufactured by the same company that makes VERSA-1. Both OxyElite Pro and VERSA-1 contain Aegeline.
The exact cause of liver damage in OxyElite Pro users is unclear, but the CDC and FDA suspect that Aegeline may play a role. FDA considers Aegeline a “new” compound used in dietary supplements. In other words, it has not been tested for the same amount of time as other supplement ingredients. In addition, little is known about exactly how the Aegeline in OxyElite Pro and VERSA-1 is made, what its potency might be, or what side effects it can cause.
In the wake of the CDC investigation as well as a “warning letter” sent by the FDA, which characterized OxyElite Pro as and “adulterated” product with insufficient evidence of safety, USPlabs announced a “voluntary” recall of certain lots of the product on November 10, 2013.
As of 2015, FDA is recommending that consumers “discontinue using any dietary supplement products labeled as Oxy Elite Pro and VERSA-1.” FDA has also advised anyone who thinks they may have been injured by these products to call their doctors immediately. Symptoms associated with the type of liver injuries that have been observed in patients taking OxyElite Pro include fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine, clay colored bowel movements, joint pain, yellow eyes, and jaundice. Untreated, these conditions may lead to irreversible liver failure that may cause death or the need for a liver transplant.
Pursue Compensation with Our OxyElite Pro Recall Lawyers
If you or someone you know has developed liver problems after ingesting VERSA-1, call the experienced OxyElite pro recall lawyers at The Senators Firm. We have represented numerous clients who have been injured by dangerous drugs and dietary supplements, insuring that they received the maximum possible compensation. Contact us today or call us at (949)-557-5800.