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FDA Adverse Event Reports Show Apparent Link Between Testosterone & Heart Attack Risk

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On January 31, 2014, the FDA released a drug safety communication concerning testosterone products like AndroGel and Testim. They stated they were investigating the “risk of stroke, heart attack, and death in men taking FDA-approved testosterone products.” They based the release of the communication on the results of two separate studies that each showed an increased risk of heart attacks and strokes in men taking testosterone therapy.

Now—according to FDA Adverse Event Reports between 2002 and 2013—at least 42 heart attacks, 44 cases of pulmonary embolism, 18 cerebral vascular accidents, and 12 deaths have been linked to problems with AndroGel, a topical gel used for the treatment of low testosterone.

Men Suffering Cardiovascular Events After Using Testosterone

A report released by Adverse Events Inc., on February 3, 2014 identified over 4,300 adverse events between November 1997 and December 2012 that listed a testosterone product as the primary suspect. They also identified 470 hospitalizations and 61 patient deaths, with 105 cases associated with stroke, heart attack, and death.

A recent Freedom of Information Act (FOIA) request also indicated testosterone products have been named in a number of cardiovascular events. It was these documents that revealed the 42 heart attacks, 44 cases of pulmonary embolism and 12 deaths associated specifically with AndroGel.

A February Bloomberg report indicated that five men had filed AndroGel lawsuits against Abbott Laboratories and parent company AbbVie Inc., claiming they suffered heart attacks or strokes after using AndroGel.

Have Advertisements Increased Usage in Healthy Men?

The FDA has not yet concluded that testosterone therapy increases the risk of cardiovascular problems, but they do note that they have approved treatment only for men “who lack or have low testosterone levels in conjunction with an associated medical condition.” Conditions may include genetic problems or chemotherapy-induced testicle malfunction resulting in low testosterone production. Other potential conditions could include problems with the hypothalamus and pituitary gland in the brain, which typically control the production of testosterone and may malfunction in some men.

Yet according to a recent study, many men are taking testosterone that have none of these conditions, and in fact, don’t even have low levels of the hormone. CBS News recently reported that annual prescriptions for testosterone more than doubled in just four years.

The men who filed AndroGel lawsuits claimed that Abbott overplayed the benefits of testosterone therapy through their television and other advertisements, while downplaying the risks. They also blamed the drug makers for concealing their knowledge that AndroGel could be seriously harmful.

Study Shows Risk of Heart Attack

Concerns over testosterone therapy have increased since scientists published a study in the journal, PLOS One on January 29, 2014.  Researchers looked at a large health-care database with over 55,000 men who were taking testosterone therapy. They found that in men over the age of 65, the risk for heart attack doubled. The risk in younger men with a history of heart disease tripled.

The FDA has urged health care professionals and patients to report any side effects involving prescription testosterone products to the FDA MedWatch program.