Consumer Group Advocates for Black Box Warning Label on Testosterone Therapy
A consumer advocacy group is petitioning the FDA to put a black box warning, the strongest warning label possible, on testosterone therapy drugs due to the potential for heart problems or stroke.
Public Citizen added that the FDA should also require testosterone therapy manufacturers to warn physicians about the associated high risk of stroke and heart attack related to the treatments.
“It is quite clear that testosterone treatment increases the risks of cardiovascular diseases, including heart attacks,” said Dr Sidney Wolfe, of Public Citizen’s health group.
“At the current rate of prescribing, almost 13,000 prescriptions a day are filled for testosterone products in this country,” Wolfe said. “Each day of delay of the black box warning ensures much more exposure, too often for men who cannot benefit from the drug but will only be exposed to its risks.”
The FDA originally approved testosterone therapy for treatment of low testosterone due to genetic factors, especially 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.
“At this time, FDA has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death. Patients should not stop taking prescribed testosterone products without first discussing any questions or concerns with their health care professionals,” the FDA said.
However, while the FDA approved testosterone therapy gels, pills, and injections for a specific kind of treatment, the drugs have been marketed for treatment of a variety of symptoms like low energy or low sex drive, which are associated with the natural aging process in men. Studies have shown that older men who use testosterone therapy to treat aging symptoms are at higher risk for heart attack and stroke – in part because they are already in these risk categories, and adding testosterone therapy makes the risks more serious.
According to Dr. Ryan Terlecki, director of the Men’s Health Clinic at the Wake Forest Baptist Medical Center, it is possible that doctors are prescribing testosterone therapy to inappropriate patients. Terlicki suggested that men with low energy ask to be screened for other possible causes, including depression and vitamin B12 deficiency.
So far, none of the studies looking at the potential risks of testosterone therapy have included what causes the increased risk of heart attack or stroke.
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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