European Regulators Investigate Link between Testosterone Therapy and Heart Problems, Parker Waichman LLP Notes

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The European Medicines Agency (EMA) is investigating the potential cardiovascular risks of testosterone therapies, according to a report in MedPage Today. In January, the U.S. Food and Drug Administration (FDA) also began investigating these products; both agencies launched their reviews due to two studies linking testosterone drugs to a higher risk of heart attack and other cardiovascular issues.

Testosterone Therapy Lawsuits

Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective drugs and medical devices, notes that the European Medicines Agency (EMA) has started reviewing the potential cardiovascular risks of testosterone therapies. According to an April 14, 2014 MedPage Today article, the agency’s review was prompted by the Estonian State Agency of Medicines; the investigation is being conducted by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC).

In late January, the U.S. Food and Drug Administration (FDA) also began investigating whether testosterone products increased the risk of stroke, heart attack and death. MedPage Today notes the EMA and the FDA reviews are both based on two studies that suggest an increased risk of heart problems with testosterone use. Last November, the Journal of the American Medical Association (JAMA) published a study showing that older men undergoing testosterone therapy were more likely to suffer from cardiovascular death. In January, PLoS One published a study showing that there was a higher risk of heart attack in older men and younger men with pre-existing heart conditions.

The FDA indicated that no FDA-approved testosterone product is approved for use in men who are diagnosed with low testosterone that is not associated with a medical condition, such as the testicles genetic failure to produce testosterone, a February 2014 Reuters report indicated. FDA-approved testosterone formulations include the topical gel; transdermal patch; buccal system, which is applied to the upper gum or inner cheek; and injection and include products such as AndroGel, Androderm, Axiron, Bio-T-Gel, and Delatestryl. Symptoms of low testosterone may include loss of libido, depression, a decrease in muscle mass, and fatigue. Testosterone products are not approved for use in men diagnosed with so-called “Low-T” who are not diagnosed with a medical condition, which may also include failure of the testicles to produce testosterone due to chemotherapy and problems with those brain structures controlling testicular production.

Mounting lawsuits also allege that FDA-approved testosterone medications caused heart attacks (Case No: 1:14-cv-00776, 1:14-cv-00780, 1:14-cv-00777, and 1:14-cv-00772), prompting Parker Waichman LLP to evaluate claims associated with these products. After the FDA announced its investigation, four lawsuits have been filed in the U.S. District Court, Northern District of Illinois alleging that the testosterone medication AndroGel caused heart attack, heart failure and stroke (Case No’s: 1:14-cv-00776, 1:14-cv-00780, 1:14-cv-00777, and 1:14-cv-00772).

If you or someone you know has taken a Low-T medication, you may have valuable legal rights. To discuss your case with one of our lawyers, please view our Testosterone lawsuit website or call 1-800-LAW-INFO (1-800-529-4636).

Parker Waichman LLP
Gary Falkowitz, Managing Attorney
1+ (800) LAW-INFO
1+ (800) 529-4636

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