FDA: Male “Enhancement” Drugs Are Deceptive, Dangerous

pills12.jpgNo matter what the advertisements say, “bigger” is not always “better.” In fact, it might even be “badder.” That’s according to the U.S. Food & Drug Administration, which is cracking down on what it calls the deceptive and potentially deadly trend of hyping male “enhancement” drugs. The agency has issued 20 public notifications just this year, notifying distributors and consumers of about 20 tainted products sold on the internet.

The products, slapped with labels like “Rock-It-Man” and “Ninja Mojo,” promise men will enjoy “sexual enhancement.” At best, the FDA warns, those claims are overstated. The bigger problem is that many of these products contain potentially dangerous ingredients.

The FDA’s notices indicate that each is made with a “hidden drug,” usually sildenafil. That’s the active ingredient in the prescription drug Viagra, an erectile-dysfunction medication.

Our dangerous drug attorneys recognize part of the problem is these drugs aren’t prescribed, so patients aren’t screened for preexisting conditions to make sure it’s safe for them to consume these substances. But beyond that, consumers likely don’t even know what they are consuming because some ingredients often aren’t even listed on the label. And it’s not as if they are purchasing these products from black market sites. These are mainstream retailers.

The FDA indicates the greatest danger is for men who suffer from high blood pressure, high cholesterol, heart disease, or diabetes, or who already take some sort of pharmaceutical nitrate to control any of these conditions. Taking a dose of sildenafil without knowing it could cause one’s blood pressure to drop precariously.

One doctor, the director for the Center of Genital Urinary Reconstruction at the Cleveland Clinic, was quoted by NBC News as saying this kind of dramatic decrease in blood pressure can actually be fatal, particularly if it involves a combination of mixing medications.

The doctor went on to say that men with erectile dysfunction may benefit from seeking a physician’s intervention. However, those with normal function aren’t going to see any benefit from using these products. He added the FDA lacks the degree of regulation over “natural” and “herbal” supplements that it really should have.

This was evidenced by the fact that, despite 20 notices issued thus far in 2014 by the agency regarding the presence of “hidden drugs,” 18 were still available domestically in September, according to NBC. Some of the distributors included mainstream retailers, such as Sears.com.

However, part of the problem seems to be a lack of communication. When the news agency contacted some of the retailers called out by the FDA as selling the item, they had no idea there was a problem. They had never received notification from the FDA or anyone else that these products were potentially dangerous.

Said one family business owner, “They’re supposed to be natural. Someone should have let us know.” The FDA issued a notice to them several days later, nearly 10 months after the original notice was issued publicly.

The Ferraro Law Firm handles claims resulting from defective medical products or dangerous pharmaceuticals. Call 1-800-275-3332 for a free and confidential consultation. Offices in Miami and Washington, D.C.

Additional Resources:
Tainted Sexual Enhancement Products, July 24,2008 – Aug. 11, 2014, U.S. Food & Drug Administration
Male “Enhancement” Drugs Called Dangerous Amid FDA Crackdown, Sept. 26, 2014, NBC News

More Blog Entries:
Payne v. Novartis Pharm. Corp. – Failure-to-Warn Claim Will Proceed, Sept. 2, 2014, Product Liability Lawyer Blog

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