Alpha Male Plus, a non-prescription supplement marketed for male enhancement, is voluntarily recalling all of its lots of fruit candies after the United States Food and Drug Administration found they contain tadalafil, an ingredient found in them. prescription drugs used to treat erectile dysfunction. Anyone who owns the product should stop using it.
Male sexual enhancement products are a category that has long been troubling to regulators.
Most of them list a combination of herbs and other natural ingredients that are believed to increase blood flow – and sometimes increase testosterone levels or increase libido – but the FDA has repeatedly found that they contain also hidden ingredients like tadalafil, the active ingredient in Cialis, or sildenafil, the active ingredient in Viagra.
These drugs require prescriptions and are limited to use under the supervision of a licensed healthcare practitioner. Male enhancers are available over the counter or online as a dietary supplement.
Supplements don’t necessarily have to meet the same standards as drugs, prescription or over the counter, that are considered unsafe until proven safe in clinical trials. Supplements are treated more as special foods and considered safe until proven to be unsafe.
The FDA is not permitted to review the safety and effectiveness of dietary supplements before they are placed on the market, according to the agency. This responsibility lies with manufacturers and distributors.
But manufacturers are responsible for ensuring that they do not contain contaminants or impurities and that they are labeled accurately.
Manufacturers and distributors of male enhancement supplements have repeatedly violated this requirement.
The FDA has issued 15 public notifications of hidden drug ingredients in this type of product so far this year.
It issued 40 in December alone and has issued dozens of such notifications every year since 2012.
Distributors of at least 12 other supplements marketed as male sexual enhancers issued recalls in March and April for the same reason.
Men who have underlying health conditions like severe cardiovascular disease could pose serious health risks from undeclared vasodilators like tadalafil, the FDA warns.
If taken by men using nitrates – often prescribed for patients with diabetes, high blood pressure or heart disease – they can cause a dangerous drop in blood pressure.
Alpha Male Plus reports that he has not received any reports of adverse events related to this recall, but the FDA is advising anyone having problems while taking this product to contact their doctor or health care provider. .
It also encourages healthcare professionals and consumers to report adverse events or side effects through the FDA’s MedWatch Safety Information and Adverse Event Reporting program at fda.gov.