Tiger Blood, Osteonecrosis and Testosterone

Los Angeles, CATestosterone lawsuits may not allege people suffered bizarre behavior as a testosterone side effect, but Charlie Sheen is reportedly blaming some of his behavior on testosterone cream. Meanwhile, a newly published study suggests testosterone is linked to an increased risk of osteonecrosis and the number of lawsuits consolidated for pretrial proceedings continues to increase.

According to Fox News (2/23/16), Charlie Sheen made an appearance on The Dr. Oz Show in February and blamed his public meltdown - which included claiming he had “tiger blood” - on overuse of testosterone cream.

“It was kind of like a borderline… not a ‘roid rage, but a ‘roid disengage.”

Despite Sheen blaming his behavior on testosterone therapy, a doctor speaking with The Daily Beast (2/23/16) said he had never heard of testosterone gel causing erratic behavior. Dr. Abraham Morgentaler, who is an Associate Clinical Professor of Urology at Harvard Medical School, said any stories linking testosterone to irritability, anger or violence are anecdotal and not backed by science.

A recently published study, however, does suggest that testosterone is linked to an increased risk of osteonecrosis and bone damage in patients who have thrombophilia. Patients with thrombophilia have blood that has an increased likelihood of forming clots. Osteonecrosis is a condition in which bone cells die from reduced blood flow.

Researchers for the study, published in the journal Orthopedics (12/15), studied 16 people - 12 men and four women - who had idiopathic osteonecrosis around six months after starting testosterone therapy and compared those 16 with 110 normal control subjects and 48 people who had osteonecrosis but were not taking testosterone therapy.

Researchers found that testosterone therapy may interact with thrombophilia, potentially putting patients at an increased risk of osteonecrosis.

Lawsuits have been filed against the makers of various testosterone therapies, alleging men were put at an increased risk of cardiovascular problems due to their use of testosterone. As of February 16, 2016, 4,863 lawsuits have been consolidated for pretrial proceedings in MD-2545 (In Re: Testosterone Replacement Therapy). That's well up from the 3,481 lawsuits consolidated as of December 15, 2015.

Those lawsuits allege they were marketed testosterone therapy as a treatment for so-called health issues that were actually a normal part of aging and were prescribed the therapy off label. Plaintiffs argue the makers of AndroGel and other testosterone products knew or should have known about the risks associated with the therapy but failed to warn patients.

Testosterone gel is approved as a replacement therapy only in men whose low testosterone levels are linked to hypogonadism, or disorders of the testicles or pituitary gland. It has not been approved to treat low testosterone that occurs naturally with aging. In March 2015, the FDA issued a Drug Safety Communication that prescription testosterone products would carry a warning about the possible increased risk of heart attacks and strokes.

There is no word on whether the FDA will now update the label to include a warning about the risk of developing “tiger blood.”