The U.S. Food and Drug Administration (FDA) is advising the public that it is evaluating studies showing that prescription testosterone products might cause stroke, heart attacks, and death in men who use them.
What Are Testosterone Products and What Are They Prescribed For?
Testosterone is a hormone that plays a major role in promoting masculine traits and men’s health. The FDA approves testosterone replacement drugs for men who lack the hormone due only to a medical condition, such as chemotherapy, failure or the testicles to produce testosterone due to a genetic defect, or neurological problems that interfere with testosterone production.
Prescription testosterone products deliver the hormone through various mechanisms: topical gels; transdermal patches; buccal products (applied to the inner cheek); and injections.
Testosterone Products Might Cause Heart-Related Side Effects
In late January 2014, the FDA issued a drug safety communication stating that it was continuing its evaluation of the safety of testosterone products after two studies were published indicating that they were more dangerous than previously recognized. The FDA did not change its position one way or another on the safety of testosterone products, just that it would take the new studies findings into account.
The first study appeared in the Journal of the American Medical Association in November 2013. The researchers studied a group of men in the U.S. Veterans Affairs health system that had low testosterone levels and were undergoing cardiac tests. Some of the men were receiving testosterone treatment while others were not. The men were about 60 years old on average. The study found that recipients of testosterone products were 30 percent more likely to suffer stroke, heart attack, or death.
The second study was published in PLOS One in January 2014, and it compared the health outcomes of more than 55,000 men who filled prescriptions for testosterone products to their health in the previous year. The authors found that men over the age of 65 who filled testosterone products prescriptions were twice as likely to suffer a heart attack within the next 90 days. Younger men who had a history of heart problems had a double or triple risk of heart attack 90 days after the testosterone products prescriptions were filled. Younger men had no discernible increased risk of heart attacks.
Even though the FDA has not formally determined that testosterone products are unsafe, it is still possible for injured men and their families to hold the manufacturers accountable legally.
Chhabra Gibbs & Herrington PLLC Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again.
‘We believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a lawsuit on your behalf if necessary. If you or a loved one has used a testosterone product, and you believe it caused an injury, contact Chhabra Gibbs & Herrington PLLC today by messaging us, through live chat, or calling this number: 601-948-8005.
