Auxilium Pharmaceuticals received FDA approval on October 31, 2002 for Testim, a testosterone supplement administered via transdermal patches or gel applied to the upper arms and shoulders on a daily basis. Testim was only approved for use among men with very low testosterone levels or those who have stopped producing the hormone altogether; however, huge numbers of men across the nation are being prescribed the drug off-label for symptoms many believe are simply the natural aging process.
It is believed that an overabundance of hard-hitting advertising campaigns is responsible for the huge surge in the use of prescription testosterone drugs. The advertisements imply that men experiencing decreases in energy, low libido, reductions in muscle mass, decreases in bone density and strength, increases in belly fat, erectile dysfunction and even a longing for an afternoon nap are suffering from "Low-T," all of which could be rectified by testosterone therapy.
The Natural Decrease of Testosterone Levels
The fact of the matter is that testosterone levels among men peak at age eighteen, remaining stable until around the age of thirty. Testosterone levels after age thirty decrease approximately 1-3% each year, due to the normal effects of aging-as opposed to a true diagnosis of hypogonadism, or the body's inability to produce testosterone. Over five million prescriptions for testosterone supplements were issued in 2013, bringing in over $2 billion for the manufacturers.
The Potential Dangers of Testim
A study done in August 2013, described the potential risk of blood clots associated with testosterone therapy. In November 2013, a study detailed in the Journal of American Medical Association determined that men taking testosterone supplements such as Testim had as much as a 29% increases risk of stroke, heart attack and death.
As far back as 2009, the FDA issued Testim warnings, after reports of serious problems involving children who came in contact with Testim and AndroGel testosterone gel products. At that time, the FDA required the manufacturer of Testim to add a black box warning which highlighted the risks of secondary exposure. Adverse effects for children who come into secondary contact with Testim include abnormal genital growth, accelerated bone development, violent behaviors, and increased libido.
Testim Lawsuit
On February 26, 2014-just weeks after a number of lawsuits were filed against the manufacturers of Androgel-a lawsuit was filed against Auxilium Pharmaceuticals, the manufacturer of Testim. Plaintiff Joseph Myers, 56, alleges he suffered a stroke after being prescribed the testosterone drug Testim. The California man claims his personal and professional life was devastated by his stroke due to the memory loss he suffered. Myers now requires constant oxygen therapy as well. The lawsuit states that Myers had no prior history of stroke, heart attack or blood clot, and that Auxilium Pharmaceuticals funded unbranded disease awareness campaigns, designed to make men believe they suffered from low-T. The lawsuit further alleges that Auxilium failed to warn the public about potential health risks associated with Testim and that the company engaged in negligence and fraud. The lawsuit has been filed in the U.S. District Court for the Central District of California.
Adverse Health Risks Associated With Testim
The insert which accompanies Testim prescriptions lists serious side effects as:
- Ankle swelling
- Urination problems
- Stomach pain
- Nausea
- Burn-like blistering of the skin where transdermal patches are worn
- Liver problems
- Depression
- Headaches
- Low fever and loss of appetite
- Breast swelling or tenderness
National Dangerous Drug Lawyers
If you or a loved one has suffered any serious side effects from the use of testosterone replacement therapy products, such as Testim, you have a right to seek justice. To learn more about your legal options or to schedule a free consultation call the Philadelphia class action lawyers at Golomb Legal today at 1-800-355-3300 or 1-215-985-9177 or fill out our confidential Contact Form.
The national class action lawyers at Golomb Legal have successfully represented individuals in Philadelphia, Pennsylvania, New Jersey, and throughout the United States.