AndroGel Injury Reports Sent to FDA for Heart Attacks, PE, Strokes, Deaths

Documents produced in response to a recent Freedom of Information Act (FOIA) request indicate that the FDA has received dozens of adverse event reports involving heart attacks, blood clots, strokes and death associated with use of AndroGel testosterone gel in recent years.

In response to concerns surrounding the link between an increased risk of heart injury from Androgel side effects, a Freedom of Information request was filed by the Levensten Law Firm asking copies of documents from between 2002 and 2013 involving the popular testosterone replacement therapy.

According to information provided by the federal drug regulatory agency, there were at least 42 heart attacks, 44 pulmonary emboli, 18 cerebral vascular accidents and 12 deaths associated with AndroGel problems in reports submitted through the FDA Adverse Event Reporting System.

Androgel is a topical gel that is applied to the under arms for treatment of low testosterone. While it is approved for use among men with a testosterone deficiency caused by a medical condition, such as hypogonadism, critics have suggested that the drug is widely overused among men with a natural decline in testosterone levels associated with the natural aging process.

In recent months, several studies have raised concerns about the potential heart risks with testosterone treatments like AndroGel, suggesting that some men may be more prone to suffering serious and potentially life-threatening injury while taking the products. As a result, lawyers are reviewing potential AndroGel lawsuits and an increasing number of complaints are being filed nationwide.

In November 2013, a study published in the Journal of the American Medical Association found that testosterone gels, patches and injections were linked to increased risks of heart attacks, strokes, and death among older men with certain pre-existing heart problems.

That research was followed by another study released late 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. Researchers estimated that for every 1,000 men over the age of 65 who take Androgel or another testosterone product, 11.52 may suffer a heart attack injury, which compares to 5.27 per 1,000 men who do not use testosterone replacement therapy.

On January 31, the FDA announced that an investigation was being launched into the safety of testosterone treatments, which is looking into the risk of heart problems in response to the new data.

At that time the FDA noted that it has not yet determined whether testosterone treatments carry an increased risk, and that further information will be provided after the agency looks over the available data.

The number of adverse event reports submitted through the FDA’s MedWatch Adverse Event Reporting System prior to the release of these studies likely only represent a small fraction of the total number of AndroGel injuries that have actually occurred, as many physicians and doctors were unaware about the link between testosterone and heart risks.