FDA Approves Another Testosterone Drug Despite Heart Concerns

Studies have proved that taking testosterone can raise a man’s risk of stroke, heart attack and death, so why did the FDA just approve another testosterone replacement gel?

Not only are there scads of testosterone meds and delivery systems – gel, cream, patch, injection – there are also an increasing number of lawsuits over their side effects. The newest player in the testosterone arena is Vogelxo Gel, manufactured by Upsher-Smith Laboratories. One of the more well-known products is AndroGel, from AbbVie, a subsidiary of Abbott Laboratories.

As reported on AboutLawsuits.com, about 100 AndroGel lawsuits and other claims have been filed so far this year, and several thousand more complaints are anticipated to be filed by individuals in the U.S.

The complaints allege that inadequate warnings were provided for consumers and the medical community about the potential heart risks and that the drug makers failed to research their products sufficiently. (See our blog, “More Evidence that Testosterone Supplements Threaten Heart Health.”)

Many plaintiffs also say that drug makers overhype “low T,” a form of “disease-mongering” that we’ve also showcased, in “Marketing the Latest Fad, Testosterone.” Turning the normal aging process into a “problem,” as marketers of testosterone tend to do, often results in inappropriate prescriptions of testosterone, and a higher risk of a real problem.

It’s mind-bending that the FDA would approve another drug within a class that they’re investigating with regard to the need for stronger warnings, and possibly restrictions on who can use it. There are legitimate reasons for taking testosterone, but losing some muscle mass because you’re 70 and sedentary aren’t among them.

As stated on AboutLawsuits, “Testosterone replacement therapy was once considered a ‘niche’ treatment, with original estimates provided by the drug makers suggesting that only about 1 million men may require the medications due to confirmed testosterone deficiency associated with a medical condition known as hypogonadism. However, the industry now generates more than $2 billion in annual sales and tens of millions of men use the drugs.”

Although Upsher-Smith has published prescribing information for Vogelxo Gel that warns about the risks of pulmonary embolism and deep vein thrombosis (lung and vein blot clots), which can affect the heart, the information doesn’t specifically mention cardiac risks.

That’s just wrong.