Safety Alert: FDA Investigating Testosterone Drug Risks

The Food and Drug Administration recently announced it is investigating the risks associated with prescription testosterone replacements. Several recent studies have linked testosterone products to an increased risk of cardiovascular events including heart attacks and strokes. At least one consumer advocacy group says the FDA should be more aggressive and require a black box warning on the drugs.

The Background on Testosterone

Testosterone drugs like Androgel, Axiron, Testim, and Fortesta, are marketed widely on television, in magazines, and elsewhere. The drugs are only approved for use among men with low testosterone levels—the hormone that regulates male sexuality and development. Some say the mass marketing campaigns are reaching men who may not necessarily need the drugs, putting them at undue risk.

Those approved for testosterone replacement drugs include men who have low levels of testosterone due to a medical condition. That medical condition could be the failure of the testicles to produce testosterone due to a genetic problem, problems associated with chemotherapy, or hormonal imbalances in the brain. Testosterone drugs are not approved for use by men who do not have low testosterone levels due to a medical condition.

The Dangers of Testosterone Drugs

Several studies have indicated these drugs put men at an increased risk of cardiovascular events. In calling on the FDA to widen their “investigation” and include a black box warning, the group Public Citizen points out that those studies that show no additional risks associated with the drugs are all funded by the drug makers themselves. Fourteen additional studies that are not funded by the pharmaceutical companies all showed an increased risk of heart attacks or strokes.

The most recent of these studies followed 55,000 men before and after starting testosterone therapy. During the first three months of using the drugs, men over the age of 65 had twice the risk of heart attacks when compared with the year before starting use. Among men with a history of heart disease, that risk was increased 2.9-fold.

A large-scale meta-analysis involving 27 studies going back 20 years found 14 of those studies to indicate a “highly significant” increased risk of cardiovascular events. The other 13 studies were funded by the industry.

Investigation of FDA-Approved Testosterone Drugs

The FDA has announced an investigation into the possible dangers of these drugs. The FDA says patients should talk to their doctors before changing their current drug regimen and that doctors should carefully weigh the potential risks against the known benefits.

More than five million prescriptions were filled in the U.S. in 2013 for testosterone drugs. If they are putting men at a greater risk of heart attack and stroke, that’s far too many lives to put on the line.

Public Citizen says part of the problem is the “hyped-up nature” of pharmaceutical marketing campaigns, which may be leading men without an associated medical condition to ask their doctors for testosterone therapy. They say there is evidence that some 25 percent of men on testosterone drugs never underwent blood tests to check their testosterone levels in the first place.

Public Citizen is calling for an immediate addition of black box warnings for these potentially dangerous drugs.

Drug manufacturers have a legal responsibility to make and market drugs that are safe and effective and to provide adequate warnings of the dangers. People who are harmed by defective drugs can hold the drug manufacturer accountable. Contact the Frank Jenkins Law Office for more information about how we can assist.