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Orthopaedic Alerts - Implant Recall

Details
By Michelle Llamas
Michelle Llamas
Alerts
04 March 2015

FDA Reconsiders, Orders Heart Attack Warning for Testosterone

FDA Orders Testosterone Drugmakers to Add Heart Attack Warning to Label

The Food and Drug Administration (FDA) ordered testosterone drugmakers to add heart attack and stroke risk warnings to medication labels and also warned doctors against over-prescribing the medication.

The agency announced recently that pharmaceutical companies must clarify that testosterone drugs are only approved for use in men with low testosterone caused by an injury or disease. They also must warn physicians and patients that the treatment is not without risks, that the medication may increase the risk of cardiovascular problems including heart attack and stroke.

“FDA has become aware that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging,” the agency said.

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Last Updated: 04 March 2015
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