Public Citizen asks FDA to put Black Box Warning on Testosterone Therapy Products
On Tuesday, February 25, 2014, Public Citizen, a public advocacy group, appealed to the Food and Drug Administration (FDA) to label testosterone therapy products with black box warnings about their links to increased risk of cardiovascular problems.
Testosterone therapy is prescribed by doctors for male patients who lack the hormone, and experience fatigue and low libido due to their condition. 5 million prescriptions were filled in 2013 in the USA.
What is a Black Box Warning?
- A black box warning highest type of warning the FDA can put on a product.
- The label warns users that the product has high chances of producing dangerous adverse events including life-threatening side effects.
- In these warning labels, the FDA requires that the manufacturer provide a detailed summary of the adverse events and risks linked to the drug in a way that both healthcare professionals and consumers can understand.
- Examples of popular drugs which include black box warning labels are Avandia, Zoloft and Paxil. In September, the FDA adopted black box warnings for opioid painkillers.
Concerning Evidence about Testosterone Therapy
- A UCLA study of 55,000 men shows that risk of heart problems doubled within 90 days of starting testosterone therapy in men over 65 – the risk tripled in men under 65.
- Another study, published in November 2013 in the Journal of the American Medical Association, showed that most men with pre-existing conditions had a 29% increase in risk of heart attack and stroke or even death while taking the hormone.
- 27 additional trials were published in April 2013 – in 14 trials, which were not funded by pharmaceutical companies, showed that those taking the hormone have twice the risk of heart problems than those who do not.
UCLA epidemiologist, Dr. William Finkle, says that American healthcare providers need to take a step back and consult long-term research before prescribing middle aged men with this hormone therapy.
Currently, the products do not list heart problems on the long list of side effects already included with testosterone.