The U.S. Food and Drug Administration (FDA) issued a new warning against testosterone products stating that testosterone or “low-t” products may lead to heart attack or other side effects. It was suggested that only men who actually have low-t levels should use testosterone products.

Testosterone products include gels, creams, patches, and injections manufactured by companies such as AndroGel, Testim, and Depo-Testosterone. The medical community has raised their concerns over potential testosterone side effects for a considerable amount of time.

The FDA warning required all manufacturers to change their warning label and include the risk of heart attack as well. “Based on the available evidence from studies and expert input from a FDA Advisory Committee meeting, FDA has concluded that there is a possible increased cardiovascular risk associated with testosterone use,” the FDA stated. “These studies included aging men treated with testosterone. Some studies reported an increased risk of heart attack, stroke, or death associated with testosterone treatment, while others did not.”

Low-T Prescriptions

Thousands of men use testosterone products. Low testosterone treatments are technically only supposed to be given to men who have low-t levels. However, most men use the product to fight symptoms of aging. Off-label testosterone use has become common across the country. However, many studies have suggested that there are serious potential testosterone side effects, like heart attacks, which may not be worth the benefit of taking low-t supplements.

The FDA determined that additional research was required as the testosterone studies were not definitive. They also recommended that low-t products only be prescribed to men who required the treatment due to actual low-t levels.

“FDA cautions that prescription testosterone products are approved only for men who have low testosterone levels cause by certain medical conditions,” according to the FDA warning. “The benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone.”

Now, additional tests are required before men can use testosterone products. The patients must also be informed about potential testosterone side effects like heart attacks.

Testosterone Product Lawsuits

The number of testosterone product lawsuits has increased over the past year as more men became aware of potential testosterone side effects or suffered from heart attacks allegedly caused by low testosterone treatment.

Testosterone product lawsuits have claimed that manufacturers have failed to adequately warn against testosterone side effects. Studies have suggested that men who use low-t products are 40 percent more likely to suffer from a heart attack.

Testosterone product lawsuits have been consolidated into a low-t drug MDL or multidistrict litigation in order to smooth the legal process for the large number of similar testosterone product lawsuits.