Norway. The Norwegian Medicines Control Agency (NMCA) has issued a reminder that ethinylestradiol/ cyproterone (Diane) is associated with an increased risk of thrombosis. The NMCA has received 26 reports of adverse reactions associated with Diane, including 15 of venous thrombosis, two of which were fatal. They note that ethinylestradiol/ cyproterone (Diane) should be used with the same caution as oral contraceptives, and should not be used in women with known risk factors for thrombosis, such as smoking, obesity and a personal or family history of thrombosis.

Reference:

Nytt om Legemidler, 11 August 2004. Available on the Internet at www.legemiddelverket.no