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EMA to Revise Testosterone Warnings to Include Heart Attack

Posted on Nov 24, 2014

The European Medicines Agency (EMA) has received a recommendation from its Pharmcovigilance Risk Assessment Committee (PRAC) to add warnings about heart attacks to testosterone labeling. The recommendation follows the EMA's investigation into testosterone medications that was started on April 11, 2014.

The PRAC has recommended updating testosterone's labeling in line with the latest evidence and to provide warnings about those who might be at increased risk of heart problems. The new warnings will include the following warning:

  • Some recent studies have suggested that using testosterone may increas a man's risk of heart attacks or other serious effects on the heart and circulation.

If you or a loved one had a heart attack, stroke, pulmonary embolism, congestive heart failure or blood clot while taking testosterone medications, like AndroGel, please call our experienced AndroGel attorneys at (888) 606-5297 for a free consultation about your potential testosterone lawsuit.

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