Testosterone Therapy Triggers FDA Safety Concerns
In January, the FDA issued a “Safety Announcement” for the use of testosterone therapy treatments. According to its alert, the FDA is investigating “the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products.”
The FDA said it is reassessing the safety of testosterone therapy after two recent studies showed an increased risk of cardiovascular events. Most of the findings relate to men with underlying heart conditions and/or men over 60.
Risks Found for Men with Underlying Heart Conditions
The first study cited by the FDA was published last fall in the Journal of the American Medical Association (JAMA). That came from a study of older men in the U.S. Veteran Affairs health system. On average, the men were about 60 years old, and many had underlying heart disease. These men had low serum testosterone and some of the men received testosterone treatment while others did not. This study found a 30% increased risk of stroke, heart attack, and death in the group taking testosterone treatments.
The FDA cited a second study reporting an increased risk of heart attack in younger men with heart disease, and in older men without a history of heart problems, who took testosterone therapy. In both of those groups, the risk for heart attack doubled within 90 days after beginning testosterone treatments. (Younger men without a history of heart disease, however, did not show increased risk of heart attack.)
Clearly, the studies show an association between testosterone therapy and increased risk of heart attack, but so far no direct cause-and-effect relationship has been shown. This is no doubt why the FDA is taking a cautious approach at this point. Until more is known, the FDA recommends that patients and doctors weigh possible additional heart risks against the other benefits of the drug in their particular case.
Possible Misuse of Testosterone Therapy
FDA-approved testosterone treatments can be applied using a topical gel, skin patch, buccal system (applied to upper gum or inner cheek), or by injection.
The FDA notes that it has approved testosterone products only for men who lack or have low testosterone levels in conjunction with an associated medical condition. Examples of these conditions include failure of the testicles to produce testosterone or problems with brain structures that control the production of testosterone. The FDA stresses that none of the FDA-approved testosterone products are approved for use in men with low testosterone levels who lack an associated medical condition.
This is where aggressive marketing by the drug manufacturers may be putting some men at risk who are being misdiagnosed for treatment. The doctors who reported the study in the JAMA found that 25% of patients being prescribed testosterone therapy hadn’t even actually had their testosterone levels tested.
WebMD warns that intensive marketing of this hormone to help aging men improve low sex drive and reclaim diminished energy may result in men taking the drug for problems that testosterone doesn’t treat. The website cautions, “[M]en who have a lack of energy should first see their doctor and ask about screening for depression and other conditions — such as thyroid disease or B12 deficiency — that could also be the cause.”
Indeed, levels of testosterone decline naturally in men as they age, so it raises the question of when does drug marketing raise false hopes in offering men some kind of youth-serum “fix” that their body doesn’t need and that could be dangerous.
The Wall Street Journal reports that in the U.S., prescriptions for testosterone, including refills, have more than doubled since 2008, from 208 million in 2008 to 432 million last year.
For anyone currently using testosterone therapy, the FDA does not recommend stopping the drug without first consulting your doctor. The Safety Announcement clarified that, “At this time, FDA has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death.”
Thomas Law Offices, a Kentucky personal injury law firm that works extensively in the area of defective drugs and medical devices, is currently investigating potential cases involving testosterone therapy. If you believe you or a loved one was injured while undergoing testosterone treatments, you may be eligible to file a Louisville testosterone lawsuit. Call Thomas Law Offices for a free evaluation of your case.