The U.S. Food and Drug Administration (FDA) has ordered drug makers to include stroke and heart attack risk warnings to testosterone medication labels. On March 3, 2015, the agency announced that pharmaceutical companies must clarify that testosterone products and treatments are only approved for use in men living with low testosterone caused by disease or an injury. Drug makers must also warn patients and physicians that testosterone treatment is not without risks and that the drugs may also increase the risk of cardiovascular complications, including stroke and heart attack.
If you took a testosterone drug and suffered a stroke, heart attack, or other complications, contact Attorney Group for more information about your options. In a free consultation, we can answer your questions, and if you have a case, we can connect you with an affiliated testosterone drug lawsuit attorney who can assist you throughout the legal process.
FDA Warning Overview
In its warning, the FDA stated that testosterone drugs were being promoted to relieve symptoms in men who have low testosterone levels for no apparent medical reason other than aging. According to the agency, the safety and benefits of this use have not been established. Currently, information about testosterone treatments is vague enough that drug makers can market these products to healthy older men with natural testosterone declines due to aging and who wanted to “regain their youth.”
The FDA’s warning comes after more than one year of investigations into testosterone drug risks of stroke and heart attack. The consumer watchdog group Public Citizen is in favor of the FDA’s requirements, but the group also questions the “inexcusable delay” in action. In February 2014, the group petitioned the FDA to add a black-box warning to testosterone medications.
Millions of men worldwide are administered testosterone medications like Testim, AndroGel and Axiron, which are promoted in multi-million dollar advertising campaigns marketing the products as treatments for low sex drive, fatigue, and depression, which are also common signs of aging. According to Bloomberg Business, AndroGel was second in drug maker AbbVie’s sales last year, generating $934 million in revenue. However, many patients claim that these products caused them to have strokes, heart attacks and other complications, and more than 1,000 testosterone drug lawsuits are pending against various manufacturers, including AbbVie and Eli Lilly.
Have Questions About A Potential Testosterone Drug Lawsuit?
If you or someone you love took a testosterone drug and suffered a heart attack, stroke, or other complications, contact Attorney Group for more information about your options. At no out-of-pocket cost to you, we can help answer your questions. If you have a case, we can connect you with an affiliated testosterone drug attorney who can file a lawsuit on your behalf and help you seek the compensation to which you may be entitled.