Fortesta Manufacturer Gets FDA Approval for New Injectable Drug Amid Concerns of Testosterone Safety Risk
Endo Pharmaceuticals received FDA approval of its injectable testosterone product, Aveed, for the treatment of male hypogonadism. This condition is also referred to as low testosterone. The approval comes after concern regarding the safety of testosterone drugs was raised a few months ago by patients and the healthcare community.
The FDA announced in January that it would be investigating prescription testosterone drugs for an increased risk of cardiovascular injuries such as heart attack and stroke. This announcement was made after two studies were published indicating higher risk for cardiovascular events. One study authored by Finkle et al., cites a two to three-fold increased risk for heart attack among younger men with a history of heart disease within the first 90 days following an initial testosterone prescription.
In addition to the newly approved Aveed, Endo Pharmaceuticals also manufactures Fortesta, a prescription testosterone gel. Fortesta and other popular testosterone drugs like AndroGel, Androderm, and Axiron have come under closer scrutiny as hundreds of men have experienced serious injuries like heart attack, stroke, and pulmonary embolism after taking these drugs. Lawsuits allege the drug manufacturers failed to warn doctors and patients of this increased risk for serious injury.
Testosterone Lawsuit
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