The Pharmaceutical Journal
Vol 269 No 7215 p352
14 September 2002

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Medicines Control Agency (www.mca.gov.uk)

Epogam and Efamast lose product licences

Patients prescribed gamolenic acid (Epogam or Efamast) for the symptomatic relief of atopic eczema or to treat mastalgia should be advised to have their treatment reviewed. This follows a decision by the Medicines Control Agency to withdraw the licences for these products.

The MCA says that there is no safety issue associated with the withdrawal but that the available evidence on the efficacy of gamolenic acid is not sufficient to support licensing.

No new stock will be supplied by Pharmacia, manufacturer of the products, after 7 October when the withdrawal comes into effect. Pharmacists can continue to dispense the product and reimbursement for National Health Service prescriptions will continue while stocks are used up.

A spokesman for the MCA told The Journal: "The MCA has decided that the current standard of therapeutic efficacy required to warrant having these products licensed as medicines is not sufficient. Information for patients will be available on the MCA's website [www.mca.gov.uk]. But there is no need for urgent medical advice."

Evening primrose oil is still available as a dietary supplement for those who wish to continue taking it.