Advocacy Groups Call For Heart Attack Warnings on Testosterone Drugs

By Rheingold Giuffra Ruffo & Plotkin LLP

A recent federally funded study found correlation and causation links of extremely high risks of heart attack from testosterone drugs like AndroGel, Fortesta and Axiron, which have urged consumer advocacy groups to call into question warning labels on such medications. The study found that testosterone therapy doubles the risk of heart attack, stroke and even death in men 65 or older.

Dr. Sydney Wolfe, a representative of a consumer advocacy group named Public Citizen recently filed a petition demanding the Food and Drug Administration to take immediate action by adding clear boxed warnings labels that indicate the severe cardiovascular problems associated with testosterone drugs. Additionally, Wolfe also discusses a discrepancy for the reporting of data in studies funded by drug companies. In April, whereas 14 non-industry funded trials reported a two-fold increase in risk of heart problems, 13 studies funded by drug companied did not show an increase in heart problems.

This petition highlights not just the health problems associated with testosterone drugs but also the lengths drug companies go to increase their sales. Deceitful marketing tactics focused on promoting the idea of masculinity to a broader population of otherwise healthy men is an issue that needs to be addressed. The claims of testosterone drugs as a way of to increase sex drive and reduce fatigue in men have been based on short-term studies that do not clearly highlight the risks associated with such drugs. However, such marketing techniques have successfully pushed for an increase in sales.

It is essential that the FDA respond to this issue by taking an action to educate consumers about the high risks of heart attack associated with these testosterone drugs.

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