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Federal drug regulators are requiring new warnings about the potential risk of heart attacks and strokes that may be caused by side effects of testosterone drugs, indicating that the medications should only be used by men with a true medical need.
In a testosterone drug safety communication issued today, the FDA announced that it is ordering label changes for all prescription “Low T” drugs, such as AndroGel, Axiron, Testim, Depo-Testosterone and other gels, creams patches and injections.
According to the warning, the FDA has concluded that there is evidence of a possible link between testosterone drugs and heart problems.
The warning comes after more than a year of increased concerns, following the publication of several studies that suggested certain men may be more like to suffer a heart attack, stroke or suddenly die if they are using testosterone replacement therapy. Those findings also raised questions about the widespread “off-label” use of testosterone replacement therapy for so-called “lifestyle” reasons, to combat the natural effects of aging.
In September, an FDA advisory committee met and determined that more research was needed into low-T drug heart risks, and also called for the drugs to be restricted to men who had medically-verifiable hypogonadism, usually caused by disease or injury to the testicles or parts of the brain.
“FDA cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions,” the agency warned in a press release issued today. “The benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone.”
The new FDA warning indicates that manufacturers must change the labels to clearly indicate the approved uses of testosterone drugs, and that new warnings must be provided about the potential risks of heart problems.
“Based on the available evidence from studies and expert input from an FDA Advisory Committee meeting, FDA has concluded that there is a possible increased cardiovascular risk associated with testosterone use,” the safety communication states. “These studies included aging men treated with testosterone. Some studies reported an increased risk of heart attack, stroke, or death associated with testosterone treatment, while others did not.”
The FDA warns that patients taking testosterone should seek immediate medical attention if they experience symptoms of a heart attack or stroke, including:
- Chest pain
- Shortness of breath or trouble breathing
- Weakness in one part, or one side, of the body
- Slurred speech
The FDA is urging medical professionals to ensure that patients have had a diagnosis of hypogonadism, backed up by laboratory testing, before prescribing drugs like AndroGel or Testim. The agency instructs doctors to conduct tests of serum testosterone concentrations on at least two separate mornings and to avoid testing testosterone concentrations later in the day.
Doctors should also alert men to the risk of testosterone heart attacks and testosterone strokes when putting them on testosterone replacement therapy or if they are already taking low-T drugs.
The agency also announced it will require testosterone drug manufacturers to conduct clinical trials to better define testosterone drug heart attack risks.
Testosterone Heart Attack Lawsuits
Over the past year, a growing number of Androgel lawsuits, Testim lawsuits, Axiron lawsuits and other testosterone drug lawsuits have been filed by men who suffered a heart attack, stroke, deep vein thrombosis (DVT), pulmonary embolism or other injury alleged caused by use of the medications.
The testosterone litigation has come following the publication of several studies that suggest the drug makers may have provided inadequate warnings about their medications.
In November 2013, research published in the Journal of the American Medical Association (JAMA) found that older men who began taking testosterone drugs following coronary angiography were more likely to suffer cardiovascular events, such as a heart attack, stroke or death.
That study was followed by additional research published in the medical journal PLoSOne in January 2014, which found that side effects of testosterone drugs may double the risk of heart attacks for men over the age of 65, regardless of their prior health condition, as well as double the risk for younger men with a prior history of heart disease.
In January 2015, another study published in the medical journal Pharmacotherapy found that first time testosterone users may be 40% more likely to have a heart attack when compared to men who did not use the drugs.
Amid the hundreds of product liability lawsuits being filed throughout the federal court system, which raise nearly identical factual allegations, a multidistrict litigation (MDL) was established before U.S. District Judge Matthew Kennelly in the Northern District of Illinois. The coordinated pretrial proceedings have been established to reduce duplicative discovery into common issues, avoid conflicting rulings from different judges and to serve the convenience of the parties, witnesses and the courts.
The first Androgel trials are expected to begin in late 2016, which may help gauge how juries will respond to certain evidence and testimony that could be repeated throughout thousands of cases nationwide if testosterone settlements or another resolution for the litigation is not reached before then.