FDA Approves Another Low Testosterone Gel Amid Review of Heart Risks

Although federal drug regulators are continuing to investigate the heart risks associated with low testosterone drugs, evaluating whether stronger warnings are needed and if restrictions on the medications are warranted, the FDA approved yet another new testosterone replacement therapy, which will be sold under the brand name Vogelxo Gel.

Upsher-Smith Laboratories indicated in an announcement (PDF) last week that the FDA has approved Vogelxo Gel for sale in the United States.

Vogelxo Gel joins a crowded field of other testosterone gels, creams, patches and injections, including AndroGel, Axiron, Testim, Foresta, AndroDerm and others, and serious concerns have been raised regarding the risks of heart problems associated with all testosterone replacement products.

The medications are approved for treatment of testosterone deficiency caused by hypogonadism, which the industry has termed “Low T.” However, concerns have surfaced in recent years about potential heart risks and widespread overuse of the medications as a means of restoring youth and vigor.

Testosterone replacement therapy was once considered a “niche” treatment, with original estimates provided by the drug makers suggesting that only about one million men may require the medications due to confirmed testosterone deficiency associated with a medical condition known as hypogonadism. However, the industry now generates more than $2 billion in annual sales and tens of millions of men use the drugs.

Following aggressive direct-to-consumer marketing of “Low T” treatments that encourage men to seek prescription treatments if they have experienced decreased energy levels, loss of libido, weight gain or other problems commonly associated with aging, the drugs have been commonly prescribed to many men who may not have had a medical need for the testosterone replacement therapy.

Low Testosterone Drug Risks

Concerns about the potential side effects of low testosterone gel treatments have gained widespread attention this year, after several studies suggested that certain men may face an increased risk of heart attacks, strokes and death while using a low testosterone drug.

In November 2013, a study published in JAMA suggested that side effects of low T drugs may increase the risk of heart attacks, strokes, and death among older men with certain pre-existing heart problems.

That research was followed by a study published in the medical journal PLOSOne in January 2014, which found that low T treatments may double the risk of heart attack for younger men with heart disease and men over the age of 65, regardless of their prior heart conditions.

In response to the findings, the FDA launched a safety review of all testosterone replacement therapy on January 31, re-assessing the warnings provided with the medication and whether additional regulatory actions are needed.

Testosterone Heart Injury Lawsuits

A growing number of low testosterone lawsuits are now being pursued against the makers of AndroGel and other popular treatments, alleging that inadequate warnings were provided for consumers and the medical community about the potential heart risks.

About 100 AndroGel lawsuits and other claims have been filed so far this year, and it is ultimately expected that several thousand complaints will be brought by individuals throughout the United States.

All of the claims involve similar allegations that the drug makers failed to adequately research their products or warn about the risk of heart attacks, strokes, blood clots and other injuries associated with use of the medications. Plaintiffs often allege that they never would have agreed to use testosterone replacement therapy if they had been provided accurate information about the heart risks.

Plaintiffs also accuse the drug makers of overhyping “low T,” resulting in many men being prescribed testosterone to combat the normal effects of aging and placing them at unnecessary risk of heart problems.

Upsher-Smith has not set a date for the release of Vogelxo, but has already published the prescribing information (PDF), which does not appear contain any warnings about the risk of testosterone heart problems in its label, though it does warn of pulmonary embolism and deep vein thrombosis risks, both of which can affect the heart.