New Testosterone Drug Approved, Despite Heart Attack, Stroke Risk

Amid growing concerns about the risk of heart attacks and strokes from testosterone replacement therapy, the FDA has approved a new injectable testosterone drug, after previously rejecting the drug three times in the past due to safety concerns.

On March 6, Endo Pharmaceuticals announced that the FDA has approved Aveed injections for the treatment of men with low testosterone due to hypogonadism. The injections are designed to have long-term effects, only requiring men to get the testosterone shot once every few weeks.

Aveed (testosterone undecanoate) is a 3-mL intramuscular injection that would be given once at initiation of therapy, then a second shot in four weeks. After that, men would only receive the injection once every 10 weeks. The company expects to release the drug later this month.

The company hopes that the long-term effect and infrequent need of injections will be attractive to men. The injection format also has almost no chance of accidental contact with family members, particularly women or children, which is a major concern with topical testosterone products like AndroGel and Testim.

However, the FDA approval came after the agency rejected the drug three times previously. The injections contain both testosterone and castor oil, and during the last attempt at approval, in May 2013, the FDA said that it was concerned that the castor oil could cause pulmonary embolism and post-injection reactions.

The controversial decision to approve the new testosterone drug comes only days after the consumer group Public Citizen filed a petition with the FDA urging the agency to delay approval of Aveed and require a new testosterone black box warnings alerting men to the risk of heart attacks and strokes associated with use of the products.

Testosterone Health Concerns

While use of testosterone drugs, such as AndroGel, Androderm, Testim, Axiron and others already on the market, have increased dramatically over the past ten years, concerns have emerged in recent months about serious and potentially life-threatening side effects of low testosterone treatments.

Even though concerns about the potential link between heart attacks and testosterone drugs have existed for years, those concerns were brought to the forefront in November 2013, when a study published in the Journal of the American Medical Association(JAMA) suggested that testosterone drugs may increase the risks of heart attacks, strokes and deathamong older men with certain pre-existing heart conditions.

The JAMA study was followed by a report published by the medical journal PLoSOne in January 2014, which found thatlow testosterone treatments may double the risk of heart attack for young men with heart disease as well as for men age 65 and older who had no prior heart problems. The researchers estimated that for every 1,000 men over the age of 65 who uses AndroGel or another TRT product, 11.52 may suffer a heart attack. That compares to only 5.27 men per 1,000 who do not use testosterone.

Testosterone replacement therapy has increased in popularity in recent years, as direct-to-consumer marketing has encouraged men to seek prescription treatment for low testosterone levels, or “low T”, if they are experiencing fatigue, decreased sexual virility or other symptoms that are often common with aging.

In recent years, the use of testosterone drugs has increased more than a factor of five, with more than $1.9 billion in sales in 2012. More than five million testosterone product prescriptions were filled last year in the U.S. alone.

A growing number of AndroGel lawsuits, Andoderm lawsuits, Testim lawsuits and Axiron lawsuits are now being pursued by men throughout the United States who claim that they suffered a heart attack, stroke or blood clot injury after using the testosterone drugs.