Testosterone Drug Allergic Reaction Leads FDA to Request More Data on Proposed QuickShot

Federal drug regulators have launched an investigation into reports of allergic reactions linked to a proposed testosterone injection called QuickShot, which may become the first self-administered low-T shot. 

Antares Pharama is still in clinical development for the drug, but already the FDA has expressed concerns that the testosterone shot might be linked to allergic side effects. The company issued a press release on January 13, announcing FDA’s recommendations to perform a larger study before the drug can be sold on the market in the U.S.

At issue are findings from the second phase of the QuickShot clinical trials, which included a report that a man broke out in hives after receiving the shot. However, the company says it does not believe the reaction was linked to the testosterone injection. The company says it will have to add about 70 subjects to its clinical trials and observe them for at least six months.

Another testosterone shot, Depo-Testosterone, already has hypersensitivity and anaphylactoid reactions listed as potential side effects.

If approved, the drug would join Depo-Testosterone, AndroGel, Testim, Axiron and others in a testosterone drug industry that has grown to generate more than $2 billion in annual sales, yet faces recent health concerns about potential testosterone drug side effects, which may include a risk of heart attack, stroke, pulmonary embolism, deep vein thrombosis (DVT) and sudden death.

Testosterone Health Risks

Over the past year, a number of studies have linked use of testosterone replacement therapy to serious and potentially life threatening health risks. In addition, many experts have raised concerns about the widespread overuse of testosterone drugs among men with no real medical need for the medications.

In November 2013, a study 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.

Just this month, a 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.

An FDA advisory panel met in September 2014 to evaluate the link between testosterone drugs and heart risks, determining that currently available information is insufficient to clarify the connection and recommending that drug manufacturers be ordered to conduct additional studies. The panel also recommended that use of testosterone drugs be limited to men with a true medical need, urging doctors to avoid prescriptions for so-called “life-style” uses.

Testosterone Lawsuits

Following the publication of the independent research over the past year, a growing number of Androgel lawsuits, Testim lawsuits, Axiron lawsuits and other testosterone drug lawsuits have now been filed in courts throughout the U.S., alleging that manufacturers placed their desire for profits before consumers safety by failing to adequately research the drugs or warn about the potential side effects.

In the federal court system, testosterone lawsuits filed in U.S. District Courts nationwide have been consolidated for pretrial proceedings, discovery and a series of early trial dates. The lawsuits are centralized as part of a federal Multidistrict Litigation (MDL), which is pending before U.S. District Judge U.S. District Judge Matthew Kennelly in the Northern District of Illinois.

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.