Testosterone therapy lawyers at Pintas & Mullins confirm that the FDA recently gave the nod to a new injectable T-Therapy drug by Endo Pharmaceuticals. The federal agency approved this new drug in the midst of medical concern about the actual safety and efficacy of T-Therapy. Several recently published studies have linked these drugs to significantly increased risks of heart attack, stroke, and cardiac death.
This is the third attempt at approve for Endo's new drug, Aveed. According to reports, the agency and Endo finally agreed on a risk evaluation strategy that will try to prevent extreme post-injection reactions. Apparently there is significant risk of patients suffering a pulmonary oil microembolism (POME) and a specific type of life-threatening allergic reaction known as anaphylaxis.
Anaphylaxis is the same allergic reactions suffered by those severely allergic to bee stings or peanuts. The body goes into shock, airways narrow, and normal breathing become impossible, even causing death in some cases. Similarly, POME can cause serious respiratory distress in some patients, and is often seen in body builders injecting oil-based steroids. It can also cause unconsciousness, circulatory collapse, and loss of bowel function.
Endo first filed for Aveed's approval in 2007. It was previously denied so many times because FDA experts were concerned that there was no way to tell who was at risk of suffering severe reactions. To address this, Endo agreed to include a black box warning on Aveed's labels, a training program for physicians who will prescribe and administer the drug, and other actions that would limit inappropriate use.
Aveel is the first long-acting T-Therapy drug, which will only be able to be administered in clinical offices, with a 30 minute waiting time post-injection. Patients with hypogonadism will receive one initial injection, another four weeks later, and a third injection after ten weeks.
Other risks associated with this injection include prostate enlargement, sleep apnea, liver toxicity, and venous thrombosis, or blood clots in the vein which can ultimately lead to fatal pulmonary embolisms. More minor complications include insomnia, acne, irritability, and fatigue.
Studies Link Testosterone Treatments Linked to Serious Cardiac Risks
Very quickly after the FDA approval was announced patient advocacy groups started asking for its reversal. Highly esteemed medical journals have published studies linking T-Therapy products to high rates of heart attack, stroke, and cardiac death, even among otherwise healthy men.
In response, the FDA announced in January 2014 that it would launch an investigation into these findings. One physician, Dr. Sidney Wolfe, sent a letter to the FDA Commissioner regarding the agency's reckless treatment of these products. He urged the agency to include black box warnings on all T-Therapy products warning patients about the very real risks of suffering cardiac event while on the medication. He also called the FDA's approval of Aveed "unsafe and unreasonable."
Black box warnings are the most serious alert the federal agency can required drugs to include on their labels, and are typically reserved for drugs associated with a heightened risk of death. What makes this issue so egregious is that the benefits of T-Therapy drugs are, at best, limited.