FDA Orders Heart Attack Warning for Low Testosterone Supplements

In March, 2015, the FDA issued new labeling requirements to manufacturers of prescription testosterone supplements. This new labeling details the potential risks of heart attack and stroke among patients taking these supplements. The FDA also required the labeling to caution men against using testosterone supplements for any reason other than the approved use—for men with diagnosed hypogonadism. Despite the fact testosterone supplements gained FDA approval only for use in men with hypogonadism, it is estimated that less than half of all men using testosterone supplements have such a diagnosis. It is also believed that twenty-five percent or more of all men using a testosterone supplement have not even had their testosterone levels measured.

The FDA Considers Testosterone Dangers

More than a year ago, after receiving reports regarding the questionable safety of testosterone supplements, the FDA vowed to take a “hard look” at this class of drugs. Once the FDA’s investigation was completed—and the agency met with the Drug Safety and Risk Management Advisory and the Bone, Reproductive and Urologic Drugs Advisory committees to discuss the drugs—the decision was made to increase warnings on testosterone labeling. In June 2014 the FDA warned doctors prescribing testosterone and patients taking the supplement of an increased risk of deep vein thrombosis, pulmonary embolism and venous thromboembolism.

Testosterone Observational Studies and Meta-Analyses

In order to reach a decision regarding new labeling advice, the FDA reviewed five observational studies and two meta-analyses of placebo-controlled trials. The goal was to determine the risk of cardiovascular events associated with testosterone supplements. Two of the observational studies determined there was statistically significant cardiovascular injury associated with testosterone supplements, two found a mortality benefit with the supplements and one study was inconclusive. The XU meta-analysis included twenty-seven published placebo-controlled trials with mostly middle age and older subjects. Of 1,773 patients treated with testosterone, 180 suffered an adverse cardiovascular event. The Corona meta-analysis included 26 similar trials; of 1,895 men treated with testosterone, 51 major, adverse cardiovascular events were reported.

Heart Attack and Stroke Added to Labeling as Significant Risk Factors of Testosterone

The newest labeling requirements which add heart attack and stroke as risks associated with testosterone supplements will help those who have already filed lawsuits against testosterone manufacturers. Since 2001, the market for prescription testosterone supplements has grown by leaps and bounds. Testosterone manufacturers coined the marketing phrase “Low T,” urging men who suffered from fatigue, low libido, loss of muscle mass, increases in belly fat, and loss of bone density to ask their doctors for a prescription. In 2013, revenues for testosterone supplements exceeded $2.4 billion. AbbVie, the manufacturer of AndroGel, has more than half the testosterone market, therefore had more than $1 billion in sales in 2013. Other manufacturers of testosterone supplements include Eli Lilly (Axiron), Auxilium Pharmaceuticals (Testim, Testopel and Striant), Endo Pharmaceuticals (Fortesta), Pfizer (Depo-Testosterone) and Actavis (Androderm).

Symptoms Which Can Signal an Adverse Cardiovascular Event or Stroke

One study published in the Journal of American Medical Association in November 2013, put the risk of having an adverse cardiovascular event at 29 percent higher for men using a testosterone supplement than for those not using testosterone. Another study published in August 2013, detailed the potential risks of blood clots for men taking testosterone supplements. Testosterone supplements can cost from $400-$500 per month, with some insurance companies covering the cost. Patients using any brand of testosterone supplement are urged to seek immediate medical attention if they experience chest pain, slurred speech, weakness in one area or one side of the body or difficulty breathing. If you feel you have suffered injury related to a testosterone supplement, it is important to speak to a knowledgeable attorney as soon as possible to determine whether filing a testosterone lawsuit is right for you.

National Dangerous Drug Lawyers

You have a right to seek justice if you or someone you love has sustained a heart attack or cardiac complication after using a low testosterone drug. Drug companies who routinely put profits before people should pay for their negligence—and their unscrupulous behavior. To learn more about your legal options or to schedule a free consultation call the Philadelphia product liability lawyers at Golomb Legal today at 1-800-355-3300 or 1-215-985-9177 or fill out our confidential Contact Form.

The national dangerous drug lawyers at Golomb Legal have successfully represented individuals in Philadelphia, Pennsylvania, New Jersey, and throughout the United States.