Undeclared Pharmaceuticals Lead to Drug Recall of Natural Enhancement Supplements
Three sexual enhancement supplements that were marketed as “all natural” are under a drug recall due to potential undeclared pharmaceuticals.
Eugene Oregon, Inc, has issued a voluntary drug recall for African Black Ant, Black Ant, and Mojo Risen after an FDA analysis of the “natural” supplements revealed undeclared amounts of sildenafil and tadalafil, which are two FDA-approved prescription drugs used to treat erectile dysfunction. However, conclusive testing has not revealed whether all of the products contain these pharmaceutical ingredients, and the manufacturer has issued the drug recall voluntarily, as a precautionary measure.
Although both sildenafil and tadalafil are approved by the FDA, the drugs can cause a harmful reaction in consumers that also take nitrate drugs for heart conditions. The drug interaction can cause decreased blood pressure, which can be harmful to those with heart disease, high cholesterol, high blood pressure, and diabetes-related heart problems.
Eugene Oregon, Inc, has discontinued manufacturing these products and has issued a press release to notify all retailers of the drug recall. Consumers who have the supplements can return the product to the manufacturer. Any consumer with heart or blood pressure conditions who has taken the enhancement supplements, and is concerned about potential side effects, should speak with their doctor immediately.
The FDA and Failure to Regulate Dangerous Drug Recalls
Mitchell Katz, MD, said in an editor’s note that the number of dangerous drug recalls ”grossly underestimates the number of products on sale with unapproved ingredients.”
“Dietary supplements should be treated with the same rigor as pharmaceutical drugs and with the same goal: to protect consumer health,” Katz wrote.
A 2011 study conducted by Dr. Pieter Cohen, an assistant professor of medicine at Harvard Medical School, found that even supplements that had fallen under Class I dangerous drug recalls could still be purchased. According to Cohen, although the FDA issued the serious recall, it was still voluntary because the FDA has no oversight specifically over supplements. For example, the weight loss supplement Pai You Guo, recalled in 2009 because it contained a banned dangerous drug, could still be bought in 2011.
In March 2013, the FDA issued a notice to consumers that many sexual enhancement drugs contained unreported pharmaceuticals, including Viagra.
Cohen suggested that consumers who want to buy supplements should stick to those with only one ingredient, or just vitamins and minerals. Consumers could also look for supplements that have been certified by the US Pharmacopeial Convention or NSF International, which can provide assurance that the supplements do not contain illegal or unregulated pharmaceuticals.
The Strom Law Firm Can Help with Dangerous Drug Recall Cases
Strom Law Firm, L.L.C. is a leader in the consumer protection battle against dangerous drug recalls and defective devices. We represent individuals who have been killed or injured by dangerous or defective pharmaceuticals. If you or a family member have been injured or killed after using a dangerous drugs such as dietary or weight loss supplements with undeclared ingredients, contact our dangerous drug lawyers as soon as possible so that we can begin taking steps to preserve evidence and your claim immediately.We offer free consultations to discuss the facts of your case. 803.252.4800