FDA-Approved Testosterone Therapy Supplements Under Investigation for Reported Heart Risks.
The Strom Law Firm is now investigating and evaluating personal injury cases associated with testosterone therapy supplements.
The Food and Drug Administration (FDA) issued a statement on Friday, January 31st, that the agency will investigate these reported risks for men using testosterone therapy supplements:
• heart attack,
• and even death.
The FDA’s statement was spurred by two recently published studies involving low testosterone (low T) – one published in the Journal of the American Medical Association, the other published in PLoS One. Both studies concluded that testosterone therapy, which is prescribed for a variety of problems from low energy to low sex drive, increases the risk of heart attacks and strokes in various groups of men.
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 T who did not take supplements.
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.
Even though the two separate studies each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy, the FDA is not ready to declare testosterone therapy supplements a heart risk. They have instead decided to reassess the safety issue and re-evaluate their information before coming to a conclusion.
What are Testosterone Therapy Supplements?
Testosterone is a hormone essential to the development of male growth and masculine characteristics. Testosterone therapy supplements are FDA-approved only for use in men have low T or lack testosterone in conjunction with an associated medical condition.
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.
It is important to note that the FDA has never approved testosterone therapy as a treatment for low libido or low energy. “None of the testosterone products have indications for weight loss, increasing energy or improving mood,” said Andrea Fischer, a spokeswoman for the FDA, in comments published in the New York Times.
FDA-approved testosterone formulations include the topical gel (like Androgel®), transdermal patch, buccal system (applied to upper gum or inner cheek), and injection.
How We Can Help
The Strom Law Firm is a leader in the consumer protection battle and can help with Dangerous Drug Cases, including Testosterone Therapy Supplements like AndroGel®. If you or a family member suffered from a stroke, heart attack, or suffered a death while using a dangerous drug or medical product such as a testosterone therapy supplement, 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.
Call our Testosterone Therapy Supplement Lawyers for a free consultation right now. 803.252.4800
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