Testosterone Injuries examined by FDA

Testosterone Injuries examined by FDA

The FDA made a Safety Announcement today regarding Testosterone Therapy. FDA is evaluating the risk of stroke, heart attack and death regarding FDA-approved testosterone products.

The agency announced that it is has been monitoring the risk and has decided to reassess the safety issue of testosterone supplementation based on two studies which suggested an increased risk of cardiovascular events in groups of men who took testosterone therapy.

The FDA said it has not concluded that testosterone therapy increases the risk of cardio events, but that it will give its final conclusion and recommendations after a review of the current research literature.

The agency also pointed out in the alert that testosterone therapy products are approved only for men with low testosterone levels who also have an associated medical condition. These conditions can include testicular failure in producing testosterone due to genetic problems or chemotherapy. Brain structures such as the hypothalamus and pituitary can also affect testosterone output, controlling the testicles’ testosterone production.

The first publication the FDA mentions in the alert is the U.S. Veterans Affairs health system study published in Nov. 2013 in the Journal of the American Medical Association (JAMA). That study found a 30 percent increased risk of stroke, heart attack, and death in the men who had taken testosterone therapy.

The second study referenced by FDA found increased risk of heart attack in older men taking testosterone therapy, as well as in younger men with pre-existing heart disease. This study found a two-fold increase in heart attack risk among men 65 years and older in the first 90 days after the first prescription. Men under 65 who had a pre-existing history of heart disease had a two- to three-fold increased heart attack risk in the first 90 days after their first prescription. Younger men who took testosterone therapy but had no history of heart disease had no increased risk of heart attack.

See the FDA Alert.

PI Law Group is investigating “Low T” or Testosterone Injury Claims. schedule your free consultation on line for a potential Testosterone Lawsuit or call: 508-499-3366.