European Regulators Piggy-Back FDA Alert about “Low T” Risks Alleged in Testosterone Lawsuit Filings
Health regulators in Europe have begun investigating the association between certain hormone-raising medications and the risk for serious heart events; an association that has already spawned a thriving testosterone lawsuit litigation in the U.S.
A safety review recently posted on the European Medicines Agency’s website follows the findings of a study published in the medical journal, PLoS One, in January that tied use of “Low T” medications to a doubled risk for heart attacks in men older than 65, and in younger men with a history of heart disease. According to the notice on April 4th, research published later that month in JAMA: Internal Medicine lent further evidence to this link when researchers found that men with pre-existing heart disease had a higher risk of heart problems than those receiving alternative treatments.
According to the European Medicines Agency’s announcement, officials “will review all available data on the benefit-risk balance of testosterone-containing medicines (in men and women).” The European regulators will then determine whether the marketing of “Low T” treatments should be “maintained, varied, suspended or withdrawn across the EU,” the notice states.
As the review gets underway, patients who may be suffering from low testosterone levels have been urged to speak with their doctor or pharmacist.
FDA Alert Prompts AndroGel Lawsuit Filings
The EMA’s alert in April follows a similar one from the U.S. Food and Drug Administration (FDA) three months earlier that also warned of a possible association between heart attacks, strokes and other cardiovascular heart events. AndroGel, Testim and Axiron are included in the FDA’s review.
Since then, a number of lawsuits involving “Low T” medications have been filed, many of which have now been centralized in the U.S. District Court, Northern District of Illinois. Plaintiffs in these cases allegedly experienced heart attacks, strokes and other side effects, and are now seeking compensation for damages incurred by their injuries. According to claims filed in several AndroGel lawsuits, for example, the drug’s manufacturer failed to adequately warn patients about risks associated with their product, which may have been designed defectively.
How to Pursue a Testosterone Lawsuit
If you were prescribed AndroGel, Testim or another “Low T” treatment designed to raise abnormally-low levels of the hormone, call our Firm today to find out if you are eligible to file a lawsuit. Call us now at (877) 779-1414.