Epogam and Efamast (gamolenic acid) - withdrawal of marketing authorisations
The product licences for Epogam and Efamast are being withdrawn with effect from 7 October 2002.
Epogam and Efamast contain gamolenic acid (GLA) derived from evening primrose Oil. Epogam was licensed for the symptomatic relief of atopic eczema in children and adults and Efamast was licensed to treat mastalgia (breast pain).
The withdrawal follows a review by the MHRA/Committee on Safety of Medicines (CSM) of all the relevant information, which does not support the current standard of efficacy required for the authorisation of these products as medicines for the treatment of eczema and mastalgia. Existing stocks of these products will not be cleared from pharmacy shelves however new stock will not be supplied by Pharmacia after 7 October 2002. NHS reimbursement will continue while stocks are being exhausted from retail outlets.
There is no safety issue associated with the withdrawal of the licences of these products and evening primrose oil is still available in health food shops for those who wish to take a dietary supplement.
Patients taking Epogam or Efamast should have the management of their treatment reviewed at their next routine check.