Concerns of testosterone side effects, particularly the cardiovascular risks associated with testosterone replacement therapies, could slow skyrocketing sales of the drugs, analysts predict.
Testosterone treatments are used to treat low testosterone levels in men due to injury or defect, a condition known as hyopgonadism. The drugs, which include the widely prescribed Androgel and Testim, have been heavily promoted by drug companies in recent years, asking men if they suffered from low libido, weight gain, fatigue and muscle loss – symptoms that could suggest low testosterone levels, a condition these drug companies named “Low T.” In response, men marched into doctors’ offices asking for the drugs by name. And sales of testosterone supplements jumped by millions of dollars.
Food and Drug Administration (FDA) data shows that prescriptions for testosterone therapies jumped from 1.33 million people in 2010 to 2.3 million just three years later. Only about half of those men were diagnosed with hypogonadism, and only 25 percent actually underwent blood tests to confirm low hormone levels.
Sales continued to climb even as studies began to surface showing that men who used testosterone replacement drugs were at an increased risk of heart attacks, strokes and death. These reports soon brought the attention of the FDA, which conducted a safety review during which the FDA confirmed a heightened risk of blood clots but was unable to establish cardiovascular risks based on the data available.
Several lawsuits were also filed against makers of testosterone products alleging the companies did not adequately warn consumers of the dangerous side effects associated with the drugs.
An FDA advisory panel later voted to recommend that testosterone replacement therapies have more limited indications for men with only serious testosterone deficiencies. Panel members also urged the agency to include on the labels of testosterone drugs data from studies that showed an increase in heart attacks, strokes and death. The panel further recommended the agency require testosterone supplement makers to collect data on cardiovascular risks as well.
The FDA does not always follow the recommendations of its advisory panels, but it usually does. And if the agency does, it could impact the monumental sales of testosterone therapy.