Misleading direct-to-consumer advertising fueled prescription testosterone treatment sales in the United States and put millions of men at an increased risk of cardiovascular side effects and other effects, physicians warned in an editorial published in the Journal of the American Geriatrics Society.
The editorial blames pharmaceutical companies for exploiting men by pushing testosterone replacement treatments through aggressive advertising campaigns aimed directly to men. These ads promise an increased sex drive, more energy, and increased muscle mass, resulting in many men requesting the drugs from their own physicians.
Testosterone products were approved by the Food and Drug Administration (FDA) to treat hyopgonadism, a condition in which the body does not produce enough testosterone either due to a genetic disorder or injury. Men’s testosterone levels naturally decline with age, which the authors say opened a door for testosterone makers to consider a wider audience. These drug companies coined the phrase “Low T” and likened the condition to menopause in women.
The plan worked. Prescription sales for testosterone treatments jumped from $324 million in 2002 to $2 billion in 2012. It took just a few years for the ill effects of this practice came to light. Studies began to show that older men treated with testosterone products were more likely to have a heart attack, stroke or die.
Mounting studies prompted the FDA to review the products, during which the agency determined a new blood clot warning and information about cardiovascular risks should be added to the labels of all testosterone drugs. The agency also required more defined language for the drug’s indication to reduce unnecessary treatment. The agency also added to the products’ labels that “the benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone.”
Makers of testosterone treatments are facing hundreds of lawsuits claiming the companies failed to warn men of the cardiovascular risks associated with the drugs.
Source: Medical Marketing & Media