FDA Will Discuss Low-T Therapy Heart Attack Risks September 17
July 15, 2014, vancouversun.com reported that men in Canada should not use Low-T therapy products unless lab tests have confirmed that they have low testosterone. Further, men should not use products such as AndroGel and Androderm if they have heart problems, and doctors should not prescribe testosterone replacement products without first assessing a patient’s cardiovascular risks.
“A recent Health Canada safety review found a growing body of evidence suggesting that the use of replacement testosterone may pose an increased risk of heart attack, stroke, blood clots in the lungs or legs, and heart rhythm irregularities,” vancouversun.com stated.
Less than two weeks earlier, the results of a U.S. National Institutes of Health study suggested that testosterone replacement may actually lower the risk of heart attack in men “at greater risk for heart problems,” per WebMD. This study of 25,000 men over age 65 who used Low-T products for as long as eight years conflicted a previous study of 56,000 men.
“The research, published in the journal PLoS One, tracked the men for 90 days after they started the therapy,” WebMD said. “The study found that heart attack risk doubled for men over 65 once they were taking the supplements. The same effect was found in testosterone supplement users who were younger than 65 but had a history of heart disease. No such effect was seen for men under 65 years of age without a history of heart disease.”
As Fox News reported July 18, the FDA will meet in September to discuss the safety of Low-T therapy products, which are a booming business.
“Partly inspired by a ‘Low T’ advertising push, men have been scrambling to supplement low testosterone counts–technically known as hypogonadism–with products that may increase sex drive, improve mood and strengthen muscle tone,” according to fiercepharma.com.
Manufacturers are currently raking in about $1.6 billion per year, and another company is seeking FDA approval for its low-T therapy product. The FDA will consider the company’s request the day after the safety panel’s discussion.
In the meantime, the FDA has mandated that all Low-T therapy manufacturers add the risk of blood clot to their product labels.
“Because these clots occur in the veins, this new warning is not related to FDA’s ongoing evaluation of the possible risk of stroke, heart attack, and death in patients taking testosterone products,” the FDA’s website stated in June.
Bloomberg recently reported that 45 federal lawsuits are pending against AndroGel makers Abbott Laboratories and AbbVie Inc. If you have a question about adverse side effects you suffered while taking AndroGel or another Low-T therapy product, attorney Chris Mellino invites you to contact our Cleveland office for a free consultation.