Three days ago, drugmakers such as AbbVie and Actavis were probably shedding some tears over the FDA sounding the siren on testosterone drugs. With all of the attention the past year with multiple low testosterone lawsuits (620 and counting) being filed by men who have been injured by medications like AndroGel and AndroDerm, it isn’t much of a surprise that the red flag is waving.
The FDA is now warning doctors against prescribing low testosterone therapy drugs to men that have not been tested or diagnosed with an actual medical condition. The drugs have not been evaluated as safe or effective for age-related issues; therefore, doctors should stop writing scripts to men without true medical issues such as hypogonadism.
As if that weren’t enough, the FDA took it a step further and is making the manufacturers add an important warning about heart attack and stroke risks in patients using this type of therapy. After much research and the conclusion of multiple studies, the FDA has now found that using low testosterone medications elevates a risk for cardiovascular health issues. Some studies found an increased risk of heart attack, stroke and even death linked to testosterone therapy treatment.
To add one last punch, the FDA is further requiring manufacturers to add a warning message on the labels concerning the risks of blood clots in the veins, also known as venous thromboembolism (VTE) which includes both deep vein thrombosis (DVT) and pulmonary embolism (PE).
It has been advised by the FDA that all health care professionals only prescribe testosterone to men with actual medical conditions associated with low testosterone that has been confirmed by lab testing. Any adverse reactions or side effects need to be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program immediately.