FDA Adds New Heart Attack, Stroke Warnings to Testosterone Drugs

New Testosterone Therapy Warnings

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FDA Adds New Heart Attack, Stroke Warnings to Testosterone Drugs

New FDA warnings must be added to the labels of low-T drugs that include the risk of side effects like heart attack, stroke and sudden death.

Federal drug regulators are requiring stronger warnings regarding the potential risk of side effects like heart attack and stroke linked to popular testosterone medications, indicating that the drugs should only be used by men with a true medical need. In a drug safety communication issued on March 3, the FDA announced that it is requiring label changes for all prescription testosterone therapy creams, gels, injections and patches, like AndroGel, Testim, Axiron and Depo-Testosterone. If you used AndroGel or another low-T drug in the past, and you have since suffered heart attack, stroke, or another serious side effect, contact a knowledgeable testosterone drug therapy lawyer today for legal help.

Potential Side Effects of Testosterone Drugs

In this new warning, the FDA indicates that there is evidence of a possible connection between testosterone replacement therapy (TRT) and an increased risk of potentially life-threatening cardiovascular problems like heart attack and stroke. The announcement comes after months of speculation about the potential health risks of testosterone therapy, including numerous studies published during the past year that have suggested certain men may be more likely to suffer a heart attack or sudden death while using the controversial medications. A growing body of research has also raised concerns about the widespread use of TRT for off-label purposes, including to fight the natural effects of aging.

Risks of Off-Label Testosterone Therapy

Testosterone drugs like AndroGel were developed as a treatment for low testosterone levels associated with hypogonadism, a medical condition characterized by diminished functional activities of the testes. However, a growing number of men across the country have been prescribed the powerful medications for off-label uses, which research suggests could put them at unnecessary risk for serious side effects. “FDA cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions,” the agency warns in its safety communication. “The benefit and safety of those 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.”

An Experienced Low-T Drug Lawyer Can Help

According to the FDA’s new drug safety requirements, the makers of testosterone medications must change the warning labels to clearly indicate the approved uses of the drugs, and include new warnings about the potential risks of serious heart problems tied to the products. If you believe you have been adversely affected by side effects of low-T drugs like AndroGel or Testim, our consumer advocates at the Consumer Justice Foundation can help. We are dedicated to protecting the rights of consumers harmed by allegedly defective medications, and can help put you in touch with a reputable attorney who has experience handling testosterone therapy claims.

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