Questions and Answers:
Q1. Why have you suddenly decided to withdraw the marketing authorisations for Epogam and Efamast?
A. The marketing authorisations have been withdrawn by the MCA following a review of all the relevant information, including new studies and statistical analyses. The data does not support the current standard of efficacy required for authorisation of these products as medicines for the treatment of eczema and mastalgia (breast pain).
Q2. Why was this information not present at the time of licensing and in hindsight should these products never have been granted marketing authorisations?
A. These products were licensed on the basis of the evidence available to the MCA at the time. The latest decision is based on both the existing and new evidence and analyses regarding the efficacy of these products, which explains the regulatory action.
Q3. Has a new safety issue come to light since the licensing of these products?
A. There is no safety issue associated with the use of these products indicated for eczema and mastalgia. Evening Primrose Oil is still available in health food shops for those who still wish to take it as a dietary supplement.
Q4. If there is no safety issue why are you withdrawing the marketing authorisations of these products?
A. Following the review of all the relevant information, the MCA has decided that the current standard of therapeutic efficacy required to warrant having these products licensed as medicines is not sufficient and therefore the licences were cancelled by the MCA. Evening Primrose Oil is still available but not as a licensed medicine.
Q5. Will it be safe to use Evening Primrose Oil bought from a health food shop?
A. Yes. There is no safety issue surrounding the use of Evening Primrose Oil.
Q6. How will patients who used Epogam and Efamast now manage their conditions?
A. There is no need for urgent medical advice – patients taking Epogam or Efamast can have the management of their treatment reviewed at their next routine check.
Q7. NHS guidelines advocate the use of gamolenic acid (derived from Evening Primrose Oil) in the management of mastalgia. Therefore why have you decided to go against such guidelines?
A. These guidelines were based on the more limited data available at the time the products were licensed. The conclusion on lack of evidence of efficacy followed the review of new studies and statistical analyses and the guidelines will therefore be revised to reflect current findings.
Q8. What was wrong with the original efficacy data supplied at the time of licensing, was it fraudulent?
A. The marketing authorisations for Epogam and Efamast are being withdrawn following a review of information from new studies and statistical analyses, which does not support the current standard of efficacy required for authorisation of these products as medicines for the treatment of eczema and mastalgia (breast pain). Pharmacia, the present marketing authorisation holder, is not implicated in fraud.
Q9. Has there been reports of Adverse Drug Reactions (ADR’s) associated with gamolenic acid a drug that should not have been licensed in the first place?
A. During the use of gamolenic acid in clinical practice there have been reports of reactions suspected to be associated with the medicine for example diarrhoea and nausea. All medicines have the potential to cause side effects. Most of these side effects are not serious and are predictable from the known actions of the drug. It is important to remember that the reporting of a particular reaction to the MCA does not necessarily mean that it has been caused by the drug. Many factors have to be taken into account in assessing causal relationships including temporal association, the possible contribution of concomitant medication, and the underlying disease. There have been no safety issues associated with gamolenic acid.
Q10. Does the withdrawal of the Marketing Authorisations (MA’s) also apply to generic versions of gamolenic acid?
A. Efamast and Epogam are the only licensed products containing gamolenic acid for the relevant indications and there are therefore formally no “generic” licensed products. There is a product, which is parallel imported and the importer has been informed that the licence for the product has ceased. Products containing gamolenic acid will still be available from health food shops and pharmacies but will not be licensed medicines and therefore not allowed to make medicinal claims.
Q11. Can Doctors still prescribe Epogam and Efamast after 7 October and will the prescriptions be reimbursed?
A. Valid prescriptions will continue to be filled until existing stock is exhausted and there are no plans to blacklist these products from reimbursement. There will, however, be no new stock supplied from Pharmacia after 7 October so once the existing stock runs out it will not be possible to fill a prescription. It is therefore important that patients discuss with their doctor suitable alternatives, to ensure a managed transition to another therapy.
Q12. What alternative treatment does the MCA recommend?
A. The MCA is legally bound to operate a licensing regime based on the safety, quality and efficacy of medicines. The Agency cannot, however, give advice on how to treat individual patients. The Department of Health is considering with Cancer Research UK how to update the guidance for general practitioners “Guidelines for referral of patients with breast problems”. All breast screening units will be notified of the outcome of these considerations. |
