The Danish Medicines Agency has reported a number of companies to the police for having failed to update the package leaflet regarding pregnant and breast-feeding women's use of antidepressants of the SSRI type (selective serotonin reuptake inhibitors). At the same time, the Danish Medicines Agency has instructed the companies to withdraw any SSRIs with inadequate warnings.
This is the outcome of a compliance check carried out by the Danish Medicines Agency to see if the warnings related to the medicines' use for treatment of depression had been updated with respect to pregnancy and breast-feeding. The package leaflets should have been updated on the website indlaegsseddel.dk within one month from 30 June 2011, and the new package leaflets were to be found in the packages within three months.
Upon the expiry of the three-month deadline, the Danish Medicines Agency carried out spot checks of nine different packages containing SSRIs, which showed that eight out of nine packages did not contain an updated package leaflet.
The Danish Medicines Agency has therefore reported the companies to the police for imposition of a fine. At the same time, the Danish Medicines Agency has instructed the companies to withdraw any SSRIs whose package leaflet is insufficient. The Danish Medicines Agency will continue to check the package leaflets in SSRI packages for some time to come.
