On April 11, 2014, the European Medicines Agency announced that it has started a review of testosterone-containing medicines, mainly used in men who do not produce enough testosterone (a condition known as hypogonadism). This review follows a similar investigation initiatied by the FDA and announced on January 31, 2014.
The review was triggered by the Estonian medicines agency, the State Agency of Medicines, over concerns about side effects of medicines containing testosterone on the heart. The safety concerns were raised following the recent publication of a study suggesting that the use of testosterone increases the risk of myocardial infarction (heart attack) in men aged over 65 years, as well as in younger men with pre-existing heart disease. This study follows other studies including the Veterans Health Care Study, which suggests that men with pre-existing heart disease who received treatment with testosterone had a higher risk of heart problems than men who did not receive testosterone.
The European Medicines Agency will now review all available data on the benefit-risk balance of testosterone-containing medicines (in men and women), and issue an opinion on whether their marketing authorisations should be maintained, varied, suspended or withdrawn across the EU.
The EMA recommend that while the review is ongoing, patients should speak to their doctor or pharmacist if they have any questions or concerns.
If you or a loved one had a stroke, pulmonary embolism or heart attack while taking AndroGel or another testosterone medication, please call our experienced AndroGel attorneys at (888) 606-5297 for a free consultation about your potential AndroGel lawsuit.