FDA news update: (March 3, 2015): The U.S. Food and Drug Administration cautions about using testosterone products for low testosterone due to aging, requires labeling change to inform of possible increased risk of heart attack and stroke with use
FDA news update (June 19, 2014): FDA adding a general warning to testosterone products about the potential for venous blood clots
If you or a loved one has suffered a heart attack, stroke or other severe side effects while taking testosterone boosters, you may be eligible to file a claim. Contact the experienced product liability attorneys at Cutter Law today for a free case evaluation.
Testosterone Boosters And Their Side Effects
On Jan. 31, 2014, the FDA announced it would be investigating the risk of stroke, heart attacks and death associated with the FDA-approved testosterone booster products.
This announcement followed a 2013 study published in the Journal of the American Medical Association (JAMA). Researchers suggested that men who use drugs to treat low testosterone, or low T, were 30 percent more likely to have a potentially fatal heart attack or stroke during a three-year period than men who have low testosterone but don’t take supplements.
Testosterone boosters or testosterone therapy also referred to as low T drugs, were approved by the FDA to treat men diagnosed with hypogonadism, an endocrine disorder that generally results in severe testosterone deficiency. However, JAMA Internal Medicine found that nearly a quarter of the men who received a prescription for testosterone therapy drugs had not undergone the necessary tests to diagnose hypogonadism.
By The Numbers
- Men in their 40s are the fastest-growing demographic of testosterone users.
- One-third of users were diagnosed with fatigue.
- Nearly 40 percent reported sexual dysfunction.
- Approximately half of the individuals prescribed low T drugs were diagnosed with hypogonadism.
In addition to the severe side effects, including stroke and heart attacks, testosterone therapy can cause acne, thickening of the blood and decreased sperm count.
Testosterone Booster Drugs Include:
- Bio-T Gel
Since 2001, low testosterone prescription drugs (including refills) have tripled, and they more than doubled from 208 million in 2008 to 432 million in 2012, according to the health-care information company IMS Health. Sales of the drugs were $700 million in 2008 and topped $2 billion in 2012.
While it is too early to tell for certain, this pattern is suggestive of a profit over people model, in which a drug manufacturer seeks to expand its market share to the detriment of its customers.
The product liability attorneys at Cutter Law P.C. have been fighting this practice for years, and we have an established history of success in similar litigation against some of the largest pharmaceutical companies in the world.
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