Lawsuits have been already filed by men who used Testim and had serious side effects. The FDA is now investigating studies linking testosterone to a 30% increased risk of stroke, heart attack, and death in the first 90 days of treatment.
Testim Lawsuit Filed in Pennsylvania
Auxilium Pharmaceuticals and GlaxoSmithKline have been hit with a Testim lawsuit. The plaintiff, a 67 year-old man from Pennsylvania, filed the lawsuit after he had a heart attack last year. The man had no prior history of cardiovascular events. He and his wife allege that the heart attack was caused by Testim.
At least two Testim lawsuits have been filed in the U.S. District Court for the Eastern District of Pennsylvania (Case Nos. 140301684 and 140302537) and another lawsuit was filed in federal court in California. Dozens more lawsuits have been filed against manufacturers of other testosterone products.
Testim and Stroke
The Prescribing Information for Testim (testosterone gel) includes explicit warnings about the risk of blood clots in the legs. This condition, also known as deep vein thrombosis (DVT), is not usually life-threatening on its own. However, if blood clots grow in arteries that supply the brain with blood, they can potentially cause an ischemic stroke or transient ischemic attack.
FDA Warns About Testim Stroke Risk
March 3, 2015 — The FDA has published a Safety Communication to announce that the makers of Testim and other testosterone replacement products must add warnings about the possible increased risk of stroke. They also must conduct clinical trials to study the risk of stroke. The FDA has emphasized that Testim is not approved for treating “Low T” due to aging. Click here to read more.
If you use Testim, seek emergency medical attention if symptoms of a stroke are present, such as:
- Chest pain
- Shortness of breath or trouble breathing
- Weakness in one part or one side of the body
- Slurred speech
Studies Link Testosterone and Stroke
In the last few years, several studies have linked testosterone replacement therapy with an increased risk of strokes and other cardiovascular events. In general, men in the studies were middle-aged or older, and many of them had pre-existing heart problems.
One study was published in the Journal of the American Medical Association (JAMA) in November 2013. Researchers linked testosterone replacement therapy with a 30% increased risk of stroke, heart attack, and death during the first three months of treatment. Men in the study were middle-aged or older (median age 60 years old) and many of them also had heart disease.