The Health Products Regulatory Authority (HPRA) has written to pharmacists warning that legacy batches of the drug sodium valproate (Epilim) still available in some pharmacies do not contain updated safety information.
In a recent letter, the HPRA highlighted several specific batches of the drug, some of which have expiry dates into 2021, that lack new advice in relation to pregnancy prevention, which was issued after a 2018 European Medicines Agency (EMA) review.
Epilim is used in the treatment of epilepsy and bipolar disorder. If a woman becomes pregnant while taking the drug, her baby is at risk of serious birth defects and developmental disorders.
In April 2018, pharmaceutical company Sanofi issued new contraindications, strengthened warnings and measures to prevent valproate exposure during pregnancy, as mandated by the EMA.
The safety information advised: “Valproate should not be used in female children, girls and women of childbearing potential unless other treatments are ineffective or not tolerated.”
The new advice led to changes to package leaflets, the inclusion of a pregnancy warning symbol on blister packs, and a pregnancy warning symbol and an updated text warning on the outer cartons.
The HPRA issued the notice to pharmacists recently to ensure that where batches with outdated leaflets were being given to women, that the most up-to-date package leaflet should be provided.
“The HPRA is aware that there are some legacy batches of Epilim products remaining on the Irish market which, although released in compliance with the relevant marketing authorisations at the time, do not contain the updates required after the 2018 review. Some of these batches have expiry dates into late 2020 and early 2021,” the letter stated.
“The HPRA wishes to highlight the existence of these batches to pharmacists. This is so that pharmacists may take measures to ensure that any woman/girl of childbearing potential who is being dispensed Epilim receives the most up-to-date information about their medicine, specifically in relation to pregnancy prevention.”