Other safety alerts
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| The United States: Testosterone Products: Drug Safety Communication - FDA Investigating Risk of Cardiovascular Events |
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The Food and Drug Administration (FDA) is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products. FDA has been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy. FDA is providing this alert while it continues to evaluate the information from these studies and other available data. FDA will communicate final conclusions and recommendations when the evaluation is complete.
Testosterone is a hormone essential to the development of male growth and masculine characteristics. Testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition. At this time, FDA has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death.
Patients should not stop taking prescribed testosterone products without first discussing any questions or concerns with their healthcare professionals. Healthcare professionals should consider whether the benefits of FDA-approved testosterone treatment is likely to exceed the potential risks of treatment. The prescribing information in the drug labels of FDA-approved testosterone products should be followed.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm384225.htm
In Hong Kong, there are six registered pharmaceutical products containing testosterone. All of the products are prescription only medicines. The Department of Health (DH) has not received relevant adverse reaction report in connection with the drug. DH will keep vigilant on any safety updates of the drug and actions taken by overseas regulatory authorities of any action deemed necessary.
Ends/ Tuesday, February 04, 2014
Issued at HKT 16:00
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