CPMP Reaffirms Third Generation Pill Safety

Third-generation oral contraceptives, the safety of which was the subject of a storm of controversy earlier this year, have been pronounced safe by the European Union's Committee on Proprietary Medicinal Products.

The CPMP issued a position statement on April 19 which recommended that no changes be made in the use of these products. The announcement follows six months of debate over whether the third-generation products were associated with a higher risk of venous thrombosis than the earlier second-generation products (Marketletters passim).

Dutch Authorities Follow Suit After the CPMP delivered its opinion, the Dutch health authorities also issued a statement indicating that there is no need to change prescription guidelines for the products. "General practitioners and pharmacists have been made sufficiently aware of the problems and risks mentioned in recent publications," said the Dutch Ministry of Health. However, the German Federal Drug Institute has recommended that these products be contraindicated in the case of first users under 30.