FDA Questions Testosterone Therapy Problems

testosterone therapy problemsAmong growing concerns about the possible relationship between heart problems and testosterone drugs, several FDA advisors are scheduled to meet in September 2014 to determine what, if any, regulatory actions should be taken to protect patients. In a recent report, FDA reviewers raised questions as to whether men with age-related decreases in testosterone actually benefit from taking products such as Testim, Axiron, AndroGel, and others.

The FDA had announced in early 2014 that its Drug Safety and Risk Management Advisory Committee and its Bone, Reproductive, and Urologic Drugs Advisory Committee would be evaluating the available data to determine if there are any risks of testosterone treatment products. However, according to the agency, there may not be enough evidence at this time to determine whether there is an increased risk of stroke or heart attack. By the same token, men who are taking these drugs may not have any real proof that the medications are beneficial.

FDA Questions Testosterone Treatment Products

The FDA launched an investigation following several studies that found that men were more likely to suffer from cardiac complications, including strokes, heart attacks, and death than those who did not take the drugs. A study in the November 2013 edition of the Journal of the American Medical Association found that side effects may increase the risk of heart problems among older men who are currently living with cardiac complications.

A second study was published in January 2014 in the medical journal PLOSOne and found that low testosterone treatments may increase the risk of heart attacks two-fold for men over the age of 65 regardless of their heart history and for younger men with heart disease. However, the new report suggests that these studies had limitations that may make their conclusions unusable by the FDA to determine whether there is enough evidence to determine any significant testosterone therapy problems.

Plaintiffs Allege Heart Complications, Wrongful Death

Since the FDA’s investigation, an increasing number of lawsuits have been filed against several manufacturers of testosterone products by plaintiffs who allege that the testosterone therapy problems and side effects were not adequately researched and that consumers were not properly warned of the potential heart risks of the products.

Drug makers are also accused of aggressively promoting the treatments for use among men who did not truly need them, and plaintiffs claim that use of these drugs caused severe testosterone therapy problems, including pulmonary embolisms, deep vein thrombosis, strokes, heart attacks, and wrongful death. All testosterone litigation was centralized in the U.S. District Court, Northern District of Illinois in August 2014.

Are You Experiencing Testosterone Therapy Problems? We Can Help

If you or a loved one used a testosterone treatment and suffered a serious condition such as a heart attack, you may be able to pursue a claim for compensation if you used a testosterone treatment and experienced testosterone therapy problems. Please contact Attorney Group today for a free case evaluation to determine whether you have a case. We can also connect you with one of our affiliated attorneys who can help you seek damages to which you may be entitled. The time to file is limited, so call today.