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Bio-T-Gel Lawsuit


Bio-T-Gel (testosterone gel) is a popular hormone replacement product for men. Unfortunately, recent studies indicate that testosterone can thicken the blood and elevate blood pressure, which substantially increases the risk of blood clots, heart attack, and stroke — especially for older men and those who have heart disease.

What is Bio-T-Gel?

Bio-T-Gel (testosterone gel) is a product that was approved in February 2012 for the treatment of hypogonadism (low testosterone) in conjunction with a medical condition like undescended testicles, chemotherapy side effects, or brain disorders. It was developed by BioSante and is sold by Teva Pharmaceuticals.

Bio-T-Gel and Low Testosterone

Bio-T-Gel is marketed for the treatment of low testosterone, or “Low T.” Advertisements suggest that men might have “Low T” if they are irritable, sad, losing muscle mass, or have sexual dysfunction. These problems are so common, it is no wonder that prescriptions for testosterone have increased five-fold since 2000 — yet only 50% of men actually have hypogonadism.

What is the problem?

Evidence linking testosterone and heart problems has been growing since at least 2009, when researchers halted a clinical trial after 7% of men on testosterone had a cardiovascular event, compared to 1% on a placebo. Since then, numerous studies have backed up these findings.

FDA Adds Heart Attack, Stroke Warnings to Testosterone Products

March 3, 2015 — In a Safety Communication, the FDA is asking manufacturers of testosterone replacement products to stop marketing them for the treatment of age-related “Low T,” add warnings about heart attacks and strokes, and start studying the long-term risks. Click here to read more.

In January 2014, the FDA published a Drug Safety Communication after reviewing two concerning studies. One study found that men over 65 had twice as many heart attacks as men who did not take testosterone. Another study found that men on testosterone were nearly 30% more likely to have a heart attack, stroke, or fatal cardiovascular event in the first 90 days of treatment.

Bio-T-Gel Side Effects

Bio-T-Gel increases the risk of cardiovascular side effects by thickening the blood, increasing the number of red blood cells, and elevating blood pressure. This can potentially lead to the following severe side effects:


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