AndroGel Problems Likely to Continue for AbbVie

Sales of AndroGel, the leading testosterone replacement therapy (TRT) product, began to slip last year and appear likely to continue to fall amid concerns about an increased risk of heart attacks, strokes and death from side effects of testosterone treatments.  

In its fourth-quarter financial results, AbbVie Inc., the maker of the AndroGel testosterone gel, indicated that sales fell 10% last year overall, and 21% in the last quarter. The drug still holds onto its blockbuster status, however, bringing in $1.04 billion in 2013, despite mounting concerns over the risk of Androgel heart problems.

Although a number of different testosterone injections, testosterone gels and other treatments are available, AndroGel has 60% of the testosterone replacement therapy market. That dominance has been expected to continue until at least 2015, when AbbVie loses patent protection and generic AndroGel equivalents may become available.

While the company attributed the slip in sales last year to rebates and “certain account losses,” a growing number of critics are expressing concerns about the widespread use of the testosterone gel. In addition, at least two studies released in recent months raised serious questions about the safety of AndroGel and other similar products, leading the FDA to launch an investigation earlier this year.

AndroGel Heart Concerns

AndroGel is a topical testosterone replacement therapy that is applied to the upper arms. It is approved by the FDA to treat low testosterone caused by a condition known as hypogonadism. However, critics say that it is being liberally prescribed to men who are seeking to reverse the effects associated with the natural decline in testosterone levels that occur as all men age.

AbbVie has drawn criticism for aggressively marketed AndroGel, using slogans like “It was a Number” and encouraging men to seek treatment for “Low T” if they experience any number of symptoms that are commonly experienced by all men at one time or another, including weight gain, decreased sex drive, reduced energy and sadness. Critics suggest that the drug maker has created a market for low testosterone treatments, although most men receiving the medications have no real medical need.

Last week, the Endocrine Society issued a statement indicating that doctors should warn users about the potential heart risks associated with AndroGel and other testosterone treatments, The Society also called for large scale studies to evaluate the testosterone therapy risks that men may face.

This statement was issued after two studies released in recent months that suggest certain men may face an increased risk of heart problems from Androgel and other testosterone products.

In November 2013, a study published in the Journal of the American Medical Association found that side effects of testosterone treatments increased risk of heart attack, stroke, and death among older men with certain pre-existing heart problems.

That research was followed by another study released last month by the medical journal PLOSOne, which found that low testosterone 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.

On January 31, the FDA announced it is investigating the potential of testosterone problems, including the potential risk of stroke, heart attack or even death. The agency said the decision to take a new look at the potential side effects of the popular hormone therapy came as a result of the recent studies.

AbbVie has already been hit with several AndroGel lawsuits filed in recent weeks, and many lawyers investigating potential testosterone cases expect that there may ultimately be thousands of cases filed nationwide. The lawsuits accuse AbbVie and other drug manufacturers of intentionally trying to frighten men into believing that natural testosterone losses represented a health risk, which some doctors have referred to as “disease mongering.”

Other manufacturers may also face similar testosterone treatment lawsuits filed by men who experience health problems, including the makers of AndroDerm, Axiron, Testim, Delatestryl, Depo-Testosterone injections, Foresta, Testopel, Striant and others.