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A panel of U.S. endocrinologists are breaking ranks with peers and calling on the FDA to pull back on proposed restrictions that would severely limit the use of testosterone replacement therapy to men suffering from hypogonadism. The group also questioned a number of recent studies that suggested side effects of testosterone treatment could increase the risk of heart attacks, strokes and sudden death.
The panel presented their viewpoints at an annual conference of the American Association of Clinical Endocrinologists (AACE), which represents about 7,000 clinical endocrinologists in the U.S.
The group challenged recent moves by the FDA to issue warnings about the risk of cardiovascular problems with testosterone replacement drugs, such as Androgel, Testim, Axiron, Androgel and others, according to a May 15 AACE press release.
On March 3, the FDA issued a drug safety communication announcing that it was requiring new warnings that indicate there is evidence of a possible link between testosterone replacement therapy and heart problems. The agency also urged doctors not to prescribe testosterone drugs to patients who had not been confirmed as having hypogonadism through serum testosterone blood tests.
The warning came after more than a year of rising concerns, following the publication of several studies that suggest certain men may be more likely to suffer testosterone heart problems after being placed on testosterone therapy. Those findings also raised questions about the widespread “off-label” use of TRT for so-called “lifestyle” reasons; to combat the natural effects of aging.
While testosterone replacement therapy was originally introduced as a “niche” treatment, amid aggressive marketing of “low T” drugs, the manufacturers have generated more than $2 billion in sales in recent years. Many of these prescriptions are considered “off label”, or men who never had testosterone levels tested or who had normal findings, with the drugs recommended to help address symptoms commonly associated with aging, such as decreased strength, lack of energy and reduced sexual drive.
At the AACE Annual Conference, one of the panelists, endocrinologist Dr. Sandeep Dhindsa, said the agency left the definition of aging unclear, and said that it was not clear if age restrictions applied to middle-aged individuals.
“Any patient being considered for testosterone replacement therapy should undergo a thorough diagnostic work-up,” Dhindsa said. “The decision to replace testosterne therapy should be guided by the signs, symptoms and testosterone concentrations rather than the underlying cause.”
Their lack of concern for testosterone use appears to fly in the face of concerns by the FDA and the Endocrine Society, which represents about 18,000 members from 120 countries.
According to the FDA, testosterone replacement therapy (TRT) is meant to treat men suffering from hypogonadism, which causes abnormally low testosterone levels. The condition usually comes due to injuries or problems with the testicles or certain parts of the brain. The only way to confirm whether someone suffers from hypogonadism is through a serum testosterone blood test.
Following recent studies that have identified a link between low T drugs and heart attacks, the FDA and the Endocrine Society have been pushing doctors to ensure that testosterone medications are only prescribed to men who have been properly tested.
The panel said that it saw no compelling evidence that testosterone drugs caused cardiovascular risk, dismissing a stream of recent studies to the contrary. They concluded that there was no evidence testosterone increased or decreased the risk of heart problems.
The AACE press release announced that the group is preparing to release a Reproductive Endocrinology position statement, claiming there is a lack of evidence for testosterone heart benefits or problems and stating that the benefits appear to outweigh the risks.
However, 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.
As the debate over the safety of testosterone replacement therapy continues among some in the medical community, a growing number of Androgel lawsuits, Axiron lawsuits, Testim lawsuits, Androderm lawsuits, Depo-Testosterone lawsuits and other product liability cases against manufacturers of “low T” drugs continue to be filed, alleging that inadequate research was conducted before marketing the drugs and that inadequate warnings were provided for consumers and the medical community.
In the federal court system, more than 1,500 complaints have been filed in U.S. District Courts nationwide, which have been centralized as part of a multidistrict litigation (MDL) in the Northern District of Illinois.
As part of the coordinated pretrial proceedings in the federal court system, a small group of Androgel cases are being prepared for trial. Known as “bellwether” cases, a series of six trials are scheduled to begin about one-per-month between October 2016 and April 2017.
A second series of early trial dates will likely be scheduled in late 2017 for cases involving other drugs. Following the bellwether trials, if the drug makers fail to reach testosterone replacement therapy settlements, they could face hundreds of individual cases going before juries throughout the U.S.