May 14, 2014 — One of the first lawsuits involving Fortesta (testosterone gel) has been filed in Pennsylvania against two drug-makers, Endo Pharmaceuticals Inc. and Prostrakan Group PLC.
The lawsuit was filed in the Philadelphia Court of Common Pleas by plaintiffs Demetric Taylor and his wife. Taylor alleges that Fortesta caused him to suffer a heart attack.
Taylor says he started taking Fortesta because he and his doctor relied on drug-makers’ claims that low testosterone was a widespread disease that needed to be treated with testosterone replacement therapy.
According to the complaint:
“Defendants’ advertisements suggest that various symptoms often associated with other conditions may be caused by low testosterone and encourage men to discuss testosterone replacement therapy with their doctors if they experienced any of the ‘symptoms’ of low testosterone.”
The “symptoms” of low testosterone on the website for Fortesta include sexual dysfunction (decreased libido and impotence), low energy, depressed mood, osteoporosis, decreased strength, loss of muscle mass, and more. The problem is that these are not necessarily caused by low testosterone.
A study published last November found that only half of men on testosterone therapy actually had hypogonadism, the only medical condition the FDA has approved Fortesta to treat, and 25% received a prescription without ever having a blood test.
Another problem is that Fortesta is not a treatment to be taken lightly — it is a lifetime commitment that can have life-threatening side effects. The Prescribing Information warns about blood clots in the legs, a condition also known as deep vein thrombosis (DVT). The FDA is also investigating studies linking testosterone therapy with an increased risk of heart attack and stroke.