Kaiser Gornick LLP is currently investigating claims involving heart attacks and strokes related to "low testosterone" or "Low T" treatments. In the US, Low T drugs are approved for use in men who have low testosterone levels due to certain medical conditions, such as chemotherapy or a genetic predisposition.
On March 3, 2015, FDA issued a Drug Safety Communication, requiring all manufacturers of testosterone products to revise their labels with warnings "about a possible increased risk of heart attacks and strokes..." The Safety Communication further cautions that neither the safety, nor the benefit of Low T drugs has "been established for the treatment of low testosterone levels due to aging..." Thus FDA is further requiring that testosterone labeling must be updated to clarify that Low T drugs are only approved in men who have low testosterone levels due to certain narrowly defined medical conditions.
FDA issued its first safety alert about testosterone therapy risks on January 31, 2014, when it announced it would "reassess the cardiovascular safety of testosterone therapy."
Evidence has now emerged that Low T treatments are associated with an increased risk of strokes and cardiovascular problems such as heart attacks. A November 2013 study reported 29% increase in the combined risk of stroke, heart attack, and death in men who were treated with Low T drugs. Another publication from January 2014 found a two-fold increase in the risk of heart attack in men aged 65 years or older. Furthermore, the study observed a two to three-fold increased risk in younger men (aged less than 65 years) who had a history of heart disease.
Francisco Lopez-Jimenez, a cardiologist at the Mayo Clinic in Minnesota, explains the heart risks from Low T treatments are substantial, noting that "[t]hat's equivalent to smoking one or two packs of cigarettes a day, or having sky-high cholesterol..."
A recent review article observed a significant discrepancy in the cardiovascular risks reported in trials funded by the pharmaceutical industry as compared to trials not funded by the industry. Research funded with drug company dollars reported an overall 11% decrease in cardiovascular risk, but independently funded studies actually showed an overall increase in risk by 106%.
Steven Nissen, cardiologist and chair of cardiovascular medicine at the Cleveland Clinic says the FDA "should require companies that sell testosterone therapy to conduct rigorous clinical trials examining the medication's heart risks." Furthermore, Nissen is "extremely concerned" that widespread prescription of Low T drugs is "a gigantic experiment."
In 2011 alone, there were over 5.3 million Low T drug prescriptions in the United States. These testosterone products, which can be prescribed as a patch, gel or injection, include:
At the law firm of Kaiser Gornick LLP, our lawyers have extensive experience handling defective pharmaceutical claims and are currently investigating cases involving low testosterone treatments. People who have been exposed to these drugs and who have suffered a stroke or cardiovascular event should speak with an attorney as soon as possible to better understand their rights.