There has been increased concern about heart risks associated with testosterone replacement drugs after the U.S. Food and Drug Administration (FDA) announced that it was investigating the link late last month. Now, several men have come forward and alleged that the testosterone replacement drug AndroGel, caused heart attacks and other serious issues.
Bloomberg reports that on February 4th, five men between the ages of 50 and 63 filed lawsuits over AndroGel; 3 men alleged heart attacks, a fourth alleged a stroke and the fifth says he suffered a mini-stroke. The lawsuits allege that Abbott and its spin-off company AbbVie misrepresented the safety of AndroGel by using celebrity endorsements and statistics about supposed widespread need for the drug while failing to mention the risks.
Another AndroGel lawsuit was filed last week on behalf of a man who alleges that the drug caused deep vein-thrombosis and pulmonary embolism. Deep vein thrombosis is when a blood clot forms in a deep vein. Pulmonary embolism is a potentially deadly complication of deep vein thrombosis; it is when a piece of the clot breaks off and causes blockage in the lung. According to this lawsuit, AndroGel increases the risk of blood clots by thickening the blood.
On January 31st, the FDA said that it was investigating the risk of heart attack, stroke and death associated with the use of testosterone therapy. The review was prompted by two studies showing increased cardiovascular risk in men who took such drugs. Last November, the Journal of the American Medical Association (JAMA) studied a population of men, many of whom had underlying heart problems, and compared those who took testosterone to those who did not. The study found that men who took testosterone replacement drugs were 30 percent more likely to suffer from stroke, heart attack and death. In January, a study in PLoS One found that in older men with no history of heart disease, testosterone therapy doubled the risk of heart attacks. In younger men who did have a history of heart disease, this risk was tripled.
The FDA has only approved testosterone therapy for men who have low levels of testosterone associated with a medical condition. However, in recent years drug companies have been pushing for widespread use of testosterone replacement therapies, citing symptoms of “low-T” such as low sex drive and fatigue. The recent findings have some experts worried that men are exposing themselves to heart risks by taking drugs that they don’t need.