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FDA Issues Safety Announcement, Evaluates Risk of Adverse Heart Effects Associated with Testosterone

On Friday, January 31, the U.S. Food and Drug Administration (FDA) issued a safety announcement that it would be investigating the risk of heart attack, stroke, and death in men who take FDA-approved testosterone products. Just recently, researchers have suggested that men over the age of 65 who take testosterone – as well as men with known heart disease – faced increased risks of heart attack. Two separate studies suggesting the association between testosterone therapy and the risk of cardiovascular events prompted the FDA to reassess the safety issue.

The safety announcement states that the FDA has not yet determined that FDA-approved testosterone products increase the risk of heart attack, stroke, or death, and that patients should first consult their physician before discontinuing prescribed testosterone. It also states that FDA-approved testosterone products should only be used by men who have low testosterone in conjunction with an associated medical condition. It should not be used by men who have low testosterone and no associated medical condition.

The problem of too many men being prescribed testosterone therapy has alarmed many medical experts and researchers. The popularity of FDA-approved testosterone treatments – including topical gels, transdermal patches, buccal system, and injections – have skyrocketed in recent years.

Research Into Risks Continues

The two recent studies cited by the FDA both found a significant increase in heart risks for men taking testosterone and especially in men with a history of heart disease. Currently, the FDA is continuing to study the association between these products and adverse events, and encourages anyone who has experienced harm after taking an FDA-approved testosterone product to speak with their health care providers. You can read more on the official FDA safety announcement.

If you or your loved one has suffered harm after using testosterone and have questions about your legal rights, call The Senators (Ret.) Firm at (800) 773-0849.

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