The referral procedure for all CHCs is concluded. The product information is harmonised, particularly concerning warnings and precautions on the risk of venous and arterial thromboembolism (VTE/ATE).
25.11.2015 - Swissmedic co-ordinates the information on the above-mentioned issue in order to simplify the process, since the important notice concerns several authorisation holders: Actavis Switzerland AG, Bayer (Switzerland) AG, Berlis AG, Dermapharm AG, Effik SA, Gedeon Richter (Switzerland) AG, Janssen-Cilag AG, Labatec Pharma SA, Mepha Pharma AG, MSD Merck Sharp & Dohme AG, Pfizer AG, Pro Farma AG, Sandoz Pharmaceuticals AG, Spirig HealthCare AG.
- The product information (information for healthcare professionals and for patients) for all CHCs authorised in Switzerland was updated, harmonised and made more comprehensible concerning warnings and precautions on the VTE and ATE risk.
- The existing assessments of the VTE/ATE risk remain unchanged:
- While the use of a CHC increases the VTE risk compared to non-use, this risk is lower than that during pregnancy and puerperium.
- The absolute VTE risk is small for all low-dose CHCs (< 50 μg ethinylestradiol).
- Currently available data indicate that those CHCs containing the progestogens levonorgestrel, norgestimate or norethisterone are associated with the lowest VTE-risk (see table below).
- There is no evidence for differences between the low-dose CHCs in their risk of ATE.
- When deciding to prescribe a CHC, careful consideration should be given to the individual woman’s current risk factors, particularly those for VTE, and the difference in risk of VTE between the products.
- Since risk factors for VTE can change over time they should be reassessed at regular intervals.
- The VTE risk is at its highest during the first year of use or if the use of a CHC is resumed after a break of at least 4 weeks.
- There is no need to discontinue or change the selected CHC if it has been well tolerated to date and if no new risk factors for VTE have emerged over time.
- Concerning the selection and use of a CHC, the prescribing doctor should inform the user comprehensively and in a transparent manner about the risks, the precautions and the action to take in the event of problems. In this context, Swissmedic strongly recommends using the information material issued by the Swiss Society of Gynaecology and Obstetrics (SGGG).
- It is also important to raise awareness of the symptoms of VTE and. The women should be informed of the signs and symptoms and instructed in the procedure to follow if a VTE or ATE is suspected.
- In connection with the review procedure, the product information for all CHCs authorised in Switzerland has also been updated and harmonised in respect of other safety-related findings (particularly concerning other precautions and interactions) and CHC properties.
For detailed information please see pdf document for download.