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FDA Adds Heart Attack, Stroke Warnings to Testosterone Drug Labels

By June 9, 2015 October 14th, 2019 No Comments

In recent years, countless men have turned to testosterone drugs after being bombarded by advertising promising enhanced sexual function, increased vigor, and a more youthful lifestyle. Unfortunately, many of these men have suffered from serious and sometimes fatal side effects after taking “Low T” drugs. Yesterday, the FDA stated that the companies that make these testosterone drugs will now be required to include warnings about the risk of stroke and heart attack on drug labels.

The drug safety communication about new testosterone label warnings was published on the FDA website yesterday. According to the FDA, drugs like Androgel, Testim, and Axiron could cause serious heart problems. The FDA also stated in a press release that testosterone drugs should only be prescribed to men who have diagnosed low testosterone, and not to men who request the drug for “lifestyle” reasons: “FDA cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions. 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.”

The FDA launched an investigation into heart risks linked to Low T drugs in September after receiving multiple reports of heart attacks and strokes suffered as a side effect of these medications. In the drug safety communication the agency stated, “Based on the available evidence from studies and expert input from an FDA Advisory Committee meeting, FDA has concluded that there is a possible increased cardiovascular risk associated with testosterone use. 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.”

In addition to the heightened warnings to patients, the FDA also urges physicians to only prescribe testosterone drugs to patients with hypogonadism verified by blood tests. Patients taking testosterone medications should be aware of potential warning signs including chest pain, slurred speech, shortness of breath, or weakness or pain on one side of the body.

Multiple men have already filed dangerous drug lawsuits after suffering deep vein thrombosis, pulmonary embolism, heart attack, or stroke while using testosterone medications. For more information on potential compensation for your medical expenses and suffering in a testosterone drug lawsuit, contact a personal injury lawyer you can trust.

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