A letter to physicians regarding the safe use of Yasmin
25.03.2009
In collaboration with the Agency for Medicinal Products and Medical Devices, on 25 March 2009, Bayer d.o.o. sent a letter to gynecology and dermatology specialists regarding the changes in the information on use of Yasmin (drosperinonum, ethinylestradiolum). The intention was to give an additional warning to physicians about the safe use of Yasmin.
The Summary of Product Characteristics and the Patient Information Leaflet were changed at the request of the Agency. Indication for oral contraceptive is now more clearly stated. It was strongly advised that this medicine ought not to be used solely for the purpose of treating acne. Also, additional information was provided on the increased risk of a thromboemoblic event in cases when users changed the type of oral contraceptive and in repeated users taking the contraceptive after a long period of pause. In such cases, the risk of developing a thromboembolic event is greater than in long-time users.
It is important to emphasise that a big prospective cohort clinical study has shown that the incidence of venous thromboembolisms in women who have used Yasmin for the same amount of time is the same as in women using other low-dose combined oral contraceptives.
The risk/benefit ratio of Yasmin is favourable for approved indication, proper use and taking into account the need for individual assessment of the risk/benefit ratio for each individual user. The Agency will continue to closely monitor the safe use of all combined oral contraceptives.
The text of the letter with the Summary of Product Characteristics can be found below:
„Direct advice to healthcare professionals regarding the changes in the information on Yasmin-Croatian document“
