Combined oral contraceptives (COCs) are divided into four generations depending on the type of progestogen they contain.
The European Medicines Agency (EMA) is evaluating the need for a change in the indication of third- and fourth-generation preparations.
Measures at EU level
An increased risk of venous thromboembolism is a known adverse effect of all oral contraceptives and already described in detail in the current product information. These events are very rare overall: the absolute risk is 20 to 40 cases per 100,000 woman-years.
To clarify whether the risk associated with the use of third- and fourth-generation preparations should restrict their use to patients in whom the use of other oral contraceptives is not indicated, the French Medicines Agency (Agence nationale de sécurité du médicament et des produits de santé, ANSM) has initiated an evaluation at the European level.
The Pharmacovigilance Risk Assessment Committee (PRAC) will make a recommendation after reviewing the data available on this issue. Further information is expected after the next meeting from 04.02. to 07.02.2013.
Situation in Austria
Included in this evaluation are all combined oral contraceptives of the third generation, this concerns preparations with the active ingredients:
as well as combined oral contraceptives of the fourth generation, this concerns preparations with the active ingredients:
BASG recommendations for users:
- Users are urged to observe the recommendations, warnings and contraindications of the currently valid technical information.
- Users are requested to report suspected adverse reactions to the BASG(www.basg.gv.at).
BASG recommendations for patients:
- Patients are urged to follow the instructions of their treating physician.
- There is no reason to discontinue use of a combined oral contraceptive containing any of the above agents - in any case, the treating physician should be consulted if there is any uncertainty.