Recent studies suggest that testosterone replacement gels and similar products may cause heart attacks, strokes and death in men using them for their “low T” conditions. The U.S. Food and Drug Administration (FDA) is now investigating this issue.Testosterone therapy products must be prescribed by a doctor. They are sold as gels, skin or mouth patches or injections. Popular brands include:
- Bio T Gel
- Testosterone Cypionate.
The law firm of Frank M. Eidson, P.A., is working to help those in Orlando, Winter Park and across Florida who believe they have suffered harm due to their use of these and other testosterone replacement therapy products. Contact us today to discuss your legal options in a free consultation.
Concerns Mount About ‘Low T’ Products
Testosterone replacement products are prescribed to men who have low testosterone due to medical conditions linked to genetics, chemotherapy or problems with their pituitary or hypothalamus glands. Testosterone is a hormone essential to the development of male growth and masculine characteristics.
Advertisements saying that older men can increase their sex drive and reclaim diminished energy with “low T” products have become common on TV and in other media since the FDA approved this type of therapy. As many as 5 million prescriptions for testosterone products were filled in the U.S. in 2013 alone, according to one consumer rights group estimate.
But several studies have suggested that these products can cause serious cardiovascular problems in men who use them. This includes:
- A study published in the PLOS ONE medical journal in January 2014. The study found a two-fold increase in the risk of heart attacks among men ages 65 or older within the first 90 days of being prescribed testosterone.
- A study published in November 2013 in the Journal of the American Medical Association, which reported a 30 percent higher risk of stroke, heart attack and death among men ages 60 or older who used low T products and had an underlying cardiovascular disease.
Additionally, in February 2014, Public Citizen called on the FDA to immediately add a black box warning about the increased risks of heart attacks and other cardiovascular dangers to the product labels of all testosterone-containing drugs available in the U.S.
On January 31, 2014, the FDA said it was investigating the health risk of low T products. The federal oversight agency said it has not concluded that testosterone treatment increases the risk of stroke, heart attack or death.
Patients should not stop taking prescribed testosterone products without first consulting their health care professionals, the FDA said in its safety announcement. Health care professionals should consider whether the benefits of testosterone therapy are likely to exceed the potential risks of treatment, the agency added.
Contact an Orlando Dangerous Drug Attorney
If you have suffered a heart attack or stroke after using a prescribed testosterone product, or if you have lost a loved one who was undergoing testosterone replacement therapy, our law firm may be able to assist you.
Manufacturers of low T products may be held liable for injuries and deaths linked to their products if it can be shown that these medications were defectively designed and/or that their health risks were not adequately explained to consumers.
They may be required to compensate injured men or their survivors for medical and/or funeral and burial expenses as well as for their pain and suffering and other damages.
Contact the Law Office of Frank M. Eidson to receive a free review of your case.
Sources / More Information
- FDA Evaluating Risk of Stroke, Heart Attack and Death with FDA-Approved Testosterone Products, U.S. Food and Drug Administration
- Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men, PLOS ONE
- Association of Testosterone Therapy with Mortality, Myocardial Infarction, and Stroke in Men With Low Testosterone Levels, The Journal of the American Medical Association
- Public Citizen Petitions FDA for a Black Box Warning on Testosterone Products, Public Citizen
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