As FDA Declares It Will Study Testosterone Therapy, Endocrine Society Calls for Longer, More Thorough Studies of the Drug
At the end of January of this year, the Food and Drug Administration (FDA) said that it would investigate claims that testosterone therapy approved by the agency could lead to serious heart conditions in users, including strokes and heart attacks. Hard on the FDA’s heels, the US Endocrine Society is also calling for investigations into those claims, including a fuller assessment of testosterone therapy’s risks to men with diagnosed “low T.”
Two recent studies into testosterone therapy, from pills to gels, suggested that men in a variety of age categories with other indicators of potential heart disease could significantly raise their risk of heart attack or stroke by using testosterone therapy. Risk factors for heart problems include diabetes, obesity, high cholesterol, and age.
The JAMA study followed 8,700 men nationally, men who underwent testosterone therapy were 30% more likely to have a heart attack or stroke, or die from a cardiac episode, during a three-year period than men with low testosterone who did not take supplements. Most of the men involved in the study had other problems such as high blood pressure, unhealthy cholesterol levels, and diabetes, and all the participants were in their 60’s or older. Nearly 26% of the participants using testosterone therapy had one of the potential bad outcomes during the course of the three-year study, compared to 20% of nonusers.
The most recent study, published in PLoS One, followed 56,000 men – 48,000 of whom were under 65 – for 90 days while they underwent testosterone therapy. The study concluded that the risk of heart attack for men over 65 years of age doubled in the short 3-month time span after they began testosterone therapy, as well as for the men under 65 years old who had a history of heart disease. This study was the first, according to the study’s authors, to look at the incidence of heart attacks and strokes in men under the age of 65.
“These studies have heightened concern about the safety of testosterone therapy in older men with preexisting heart disease,” the Endorine Society states.
The FDA approved some testosterone therapy for patients with hypogonadism, a condition that affects the testes, pituitary gland, hypothalamus. However, testosterone therapy has been marketed to older men whose “low T” is related to age, not to a medical condition. Patients prescribed testosterone therapy by their doctor may not have a medical need for the drug, and can therefore put themselves at risk of serious side effects.
While the FDA and drug manufacturers further investigate the heart risks associated with testosterone therapy, “physicians and patients should have a conversation about the risks and benefits of using testosterone, especially in patients who have preexisting heart disease,” the Endocrine Society notes.
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The Strom Law Firm, L.L.C. is a leader in the consumer protection battle against dangerous prescription drugs and medical devices, from Actos to testosterone therapy. We represent individuals who have been killed or injured by dangerous or defective pharmaceuticals. If you or a family member have been injured or killed after using a dangerous drugs or medical products such as testosterone therapy or supplements, contact our dangerous drug lawyers as soon as possible so that we can begin taking steps to preserve evidence and your claim immediately. We offer free consultations to discuss the facts of your case. 803.252.4800
