In 2014, two separate studies suggested that men using AndroGel and other testosterone replacement therapies for the treatment of age-related Low-T are at an increased risk of suffering an adverse cardiovascular event. Now, more than 1,300 men who were treated for Low-T have filed lawsuits against the drug manufacturers in order to obtain compensation for heart attacks, strokes and other cardiovascular injuries experienced while using prescription testosterone treatments. According to the Drug Safety Lawyers, these lawsuits are the tip of the iceberg. Tens of thousands additional lawsuits will be filed.
Jun 12, 2015 /prREACH/ -- For years, drug companies have been telling men that these normal symptoms of aging can be linked to a medical condition they called “Low-T”. Low-T, they promise, can be treated. With this treatment, men can get back in shape, regain their energy, and improve their personal relationships. The drug companies’ treatment for Low-T is a prescription testosterone replacement therapy. Testosterone drugs, including AndroGel, Axiron, Fortesta and about a dozen other medications are available as injections, pills, patches, gels and creams. Drug company ads were so effective, that in 2013, more than 2.3 million prescriptions were written to treat Low-T caused by aging. However, the FDA never approved testosterone drugs for this purpose. The FDA has only approved testosterone replacement therapy for men who have decreased levels of testosterone due to disease, cancer or injury. But, doctors and patients were told that the drug was a safe treatment for age-related Low-T, and millions of prescriptions were written. Testosterone replacement drugs became a billion dollar business. In 2014, a study published in the journal PLOS One found that heart attack risk in men age 65 and older and men with a history of heart disease doubled during the first three months of testosterone drug use. A second study, in the Journal of the American Medical Association, suggested that men who used testosterone drugs had a 30 percent increased risk of suffering a heart attack or stroke. The FDA decided it was time to investigate. The FDA spent six months studying heart attack and stroke risk linked to testosterone therapy. During the investigation, a study on nearly one million men from ages 45-80 was published in the January 13, 2015 issue of the journal Pharmacotherapy. The research determined that first-time users of testosterone treatments were 41% more likely to have a heart attack then men who were not using testosterone drugs. In March 2015, the FDA issued a safety communication requiring testosterone drug manufacturers to update the warning labels to include the risk of heart attack and stroke. The new guidelines also required manufacturers change their labels to show the approved uses for testosterone. However, the new guidelines too late for the hundreds of thousands of men who suffered testosterone heart attacks strokes, deep vein thrombosis and pulmonary embolisms. Many of these men began testosterone therapy as a step towards a healthier lifestyle. Instead, their lives were put at risk by a drug they believed was safe. Now, the men are using the legal system to fight back. As of April 15, 2015, 1,382 lawsuits were filed by men who claim they suffered serious cardiovascular effects as a result of taking testosterone. These lawsuits have been grouped as MDL 2545 (In Re: Testosterone Replacement Therapy Products Liability Litigation) in the Northern District of Illinois. The first of these lawsuits is scheduled to go to trial in the fall of 2016. According to Attorney Jon Ostroff, Esquire of the Drug Safety Lawyers, these 13,000 lawsuits are just the tip of the iceberg. Mr. Ostroff says, “Before filing a lawsuit, each claimant's medical records are typically obtained and reviewed by medical experts. This takes time. Based on our experience, there will be tens of thousands additional cases." He added, “The lawsuits are about more than compensation for drug side-effects, the lawsuits are also about drug companies that put the public’s health at risk for profit. AbbVie, GlaxoSmithKline and Eli Lilly knew that testosterone therapy was not approved for the treatment of aging. Yet, these companies spent millions of dollars promoting medications for Low-T, a condition that is not recognized as a medical disease. Doctors are allowed to prescribe medications for off-label uses, but drug companies can only market drugs for uses that are approved by the FDA. The drug companies behaved with no regard for the law, and patients paid with their health.” Men who suffered heart attacks strokes, deep vein thrombosis and pulmonary embolisms while talking Testosterone should contact an attorney about their legal rights.