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European Medicine Agency Reviewing Testosterone Therapy Treatment & Heart Risks

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The investigation surrounding testosterone therapy treatment has spread into Europe. The European Medicine Agency announced it would be reviewing “testosterone-containing medicines” over safety concerns prompted by two recent studies, one published in JAMA in November 2013 and the other in PLOS One in January 2014.

The Pharmacovigilance Risk Assessment Committee (PRAC) is conducting the review at the request of Estonia.

The agency said this review could lead to a decision to stop the sale of testosterone therapy treatment products across the European Union, or have no effect at all on sales.

FDA Announces Investigation in January 2014

The U.S. Food and Drug Administration also announced plans to investigate the risk of heart attack, stroke, or death among patients taking a form of testosterone therapy treatment. This investigation was also prompted by the same two studies that prompted a review by the European Medicine Agency.

The study published in PLOS One found men aged 65 and older had double the risk of suffering from a heart attack or stroke after using a form of testosterone therapy treatment. Researchers also studied younger men and found that they had three times the risk if they had a family history of heart disease.

The FDA requested that doctors, other healthcare professionals, and patients report any side effects to its MedWatch program.

Testosterone Therapy Treatment Side Effects

The FDA has stated that testosterone treatments should only be prescribed to men who have low testosterone levels coupled with “an associated medical condition.” Men who are diagnosed with hypogonadism do not produce enough testosterone, sperm, or both. This diagnosis can only be made by a doctor.

Besides the potential heart risks outlined in a JAMA and PLOS One study, there are other possible side effects that come with the use of a form of testosterone therapy treatment. According to the Cleveland Clinic, these can include: fluid retention; acne, oily skin; breast enlargement; decreased testicular size; stimulation of prostate tissue, contribute to sleep apnea.

The FDA also warned consumers about the risk of “secondary exposure” with some testosterone therapy treatment gels. The agency received reports about children experiencing signs of the early onset of puberty, and reports of women experiencing excess hair growth and acne when exposed to the products. In 2009, the FDA required manufacturers of Androgel and Testim to add a warning label about “secondary exposure.”

If you or a loved one have suffered or are suffering from a heart attack, stroke, or death you may be entitled to compensation. You should contact a testosterone therapy attorney today.