Sales are down for testosterone replacement therapy drugs, such as the two most popular testosterone gels, Androgel and Axiron. After a huge spike in 2013 in prescriptions and sales, 2014 was different for testosterone gel manufacturers.
Sales of Androgel fell 5% in the first half of 2014, according to Bloomberg.
The reason for the sudden increase, and just as sudden decrease, in testosterone prescriptions and sales is most likely due to the recommendations of an advisory panel assembled by the U.S. Food and Drug Administration (FDA). This FDA advisory panel met to direct the FDA in how they should move forward in regulating testosterone replacement therapy drugs.
The panel was almost unanimous in their decision that the FDA order testosterone manufacturers to update their drug labels to include warnings about the unknown nature of using these drugs for low testosterone in aging male adults.
Testosterone replacement therapy drugs have been used for decades in patients with hypogonadism, a condition where the patient is unable to produce adequate levels of testosterone. It was not until recently that testosterone became a popular way to treat signs of aging. However, the use of testosterone to turn back the clock, so to speak, is a new form of treatment, whose risks still need to be researched.
The FDA panel also encouraged the regulator to order testosterone manufacturers to conduct research into testosterone and heart health. The panel, which released their suggestions in September 2014, made their research recommendation in the wake of recent studies that have shown a link between testosterone and cardiovascular problems, including heart attack and stroke.
Carey Danis & Lowe represents men and their families in testosterone gel lawsuits. Our dedicated team of defective drug lawyers are investigating testosterone gel cases, and encourage anyone who has been injured by testosterone gel to get in touch as soon as possible.
We offer free, no-obligation case evaluations.
Carey Danis & Lowe is available to review your testosterone gel case. Contact our law firm by phone at 800.721.2519, or complete a confidential personal injury claim form.
References: Pharmaceutical litigation, Testosterone