AndroGel Health Risks May Be Hurting Sales as Low T Drug Concerns Mount
As concerns about the link between testosterone replacement therapy and heart risks continue to gain widespread media attention and lead to a growing number of lawsuits nationwide, the makers of the popular “low T” drug Androgel report that sales for their blockbuster medication have fallen for the second straight quarter.
In a third quarter earnings report released late last week, the pharmaceutical company AbbVie indicated that the demand for Androgel has fallen to just $232 million over the three month period.
This represents a drop of 6.7% in the third quarter of 2014, and comes following a drop of 15.6% reported in the second quarter. Both figures are in comparison to the same quarters in 2013, which was before concerns about the potential Androgel health risks first surfaced.
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Studies Link Androgel and Heart Risks
Androgel is a testosterone topical gel that has reached the level of blockbuster status in recent years, typically generating over $1 billion in annual sales. However, if sales continue to come in under last year’s numbers during the fourth quarter, the drug will likely fall short of that level in 2014.
Concerns about the link between Androgel and heart attacks surfaced late last year, with the publication of a study in November 2013 that found users of testosterone replacement therapy may be more likely to experience a heart attacks, strokes and sudden death.
In January 2014, a second study was published in the medical journal PLOSOne, suggesting that side effects of Low T drugs may double the risk of heart attacks for younger men with a history of heart disease, and for all men over the age of 65, regardless of their prior heart condition.
Just days after the release of that research, the FDA launched an investigation into the potential health risks with Androgel and similar testosterone drugs, such as Testim, Axiron, AndroDerm, Depo-Testosterone and others.
Androgel Lawsuits and Media Coverage
In addition to dropping sales, AbbVie could face increasing litigation costs in the coming quarters, as a mounting number of Androgel lawsuits are filed by former users who allege that the drug maker failed to adequately warn about the risk of heart attacks, strokes, blood clots and other health problems.
Demand for Androgel and other low T drugs have likely been effected by the lawsuits, as well as media coverage about the health risks.
In September 2014, the FDA held two days of advisory panel meetings to evaluate the testosterone drug safety risks, which were widely covered by the national medial
AbbVie has driven demand for Androgel and other testosterone creams, gels, patches and injections by aggressively promoting the Low T drugs in recent years for what many consider natural drops in testosterone levels that all men experience as they age.
Critics have described testosterone drug marketing as “disease mongering”, encouraging otherwise healthy men to ask their doctors for Androgel or other “low T” treatments if they experience any number of general symptoms typically associated with aging, including decreased energy levels, lack of sex drive and declining strength.
In response to the emerging evidence about the link between testosterone drugs and health risks, experts are now recommending that the FDA limit Androgel and other testosterone drugs for use among men with a true medical need and are calling for the agency to require the drug makers to complete additional studies on the medications.
According to allegations raised in testosterone injury lawsuits filed against AbbVie and other companies, the drug makers should have explored the link between heart problems and testosterone replacement therapy years ago. Plaintiffs claim that the drug makers turned a blind eye to the health risks, placing their desire for profits before consumer safety.
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