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PRODUCED BY AND FOR MEMBERS OF THE DEPARTMENT OF SURGERY March 2015 | Archived Issues

P & T Approvals, FDA Warnings About Testosterone Products, Treanda, Chantix

Pharmacy Focus

See highlights of the February meeting of the Pharmacy and Therapeutics Committee. Also, the U.S. Food and Drug Administration has issued warnings about prescription testosterone products, Treanda and Chantix.


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P & T Approvals, FDA Warnings About Testosterone Products, Treanda, Chantix

Pharmacy Focus

Highlights of the February meeting of the Pharmacy and Therapeutics Committee are summarized in the PDF link below. Also, the U.S. Food and Drug Administration has issued warnings about prescription testosterone products, Treanda and Chantix.

P & T Approvals - February 2015 (PDF)

FDA: Testosterone Products Carry Possible Increased Risk of Heart Attack, Stroke

The FDA has concluded that there may be an increased cardiovascular risk associated with the use of prescription testosterone products. 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.

For more information, click here.

FDA: Treanda for Injection Incompatible With Many CSTDs

The FDA is warning healthcare professionals not to use Treanda for injection (45 mg/0.5 mL or 180 mg/2 mL solution) with closed system transfer devices (CSTDs), adapters and syringes containing polycarbonate or acrylonitrile-butadiene-styrene (ABS). Most marketed CSTDs contain either polycarbonate or ABS and are not compatible with the product.

Devices that contain polycarbonate or ABS dissolve when coming into contact with an ingredient in Treanda for injection, according to the FDA. This can lead to device failure, possible product contamination and potential serious adverse health consequences, including skin reactions in healthcare professionals preparing and administering this product and the risk of small blood vessel blockage in patients.

For more information, click here.

FDA: Chantix Can Change Patients' Reaction to Alcohol

The FDA is warning that the prescription smoking-cessation medicine Chantix (varenicline) can change the way people react to alcohol. Interactions between alcohol and Chantix have resulted in some patients experiencing increased intoxicating effects of alcohol, sometimes associated with aggressive behavior and/or amnesia. In addition, rare accounts of seizures in patients treated with Chantix have been reported.

For more information, click here.