MHRA News: Domperidone (Motilium) can no longer be bought without a prescription...

The European Medicines Agency (EMA) recently reviewed the safety and efficacy of medicines containing domperidone and found that people who take them may have a small increased risk of potentially life-threatening effects on the heart. Therefore the indications for these medicines were restricted to nausea and vomiting.

Following this, the Commission on Human Medicines, the independent advisory body to the MHRA, reviewed the safety of this medicine for supply over the counter in a pharmacy and advised that medical supervision was needed. Domperidone will now only be available as a prescription-only medicine (POM) with effect from 4 September 2014.

Key messages

• You can no longer buy domperidone without a prescription.
• There is a small risk that domperidone may cause heart problems in some people. Your doctor can tell you if domperidone is suitable for you.
• If you have recently bought domperidone without a prescription and you wish to continue taking it, speak to your doctor or pharmacist at your next routine visit.
• If you have been prescribed domperidone, there is no need to stop taking your medicine. 
• Talk to a doctor straight away if you experience dizziness; fainting; chest pain; or a rapid, fluttering, or pounding heartbeat while taking domperidone.

For Details CLICK HERE

MHRA Class II Medicines Recall (action within 48 hours): Motilium 10 10mg Tablets and Motilium Instants10mg Orodispersible Tablets manufactured by McNeil Products Limited

Johnson & Johnson Ltd., on behalf of the Marketing Authorisation Holder McNeil Products Limited, is recalling all unexpired stock of the Motilium 10 10mg Tablets and Motilium Instants10mg Orodispersible Tablets.

Johnson & Johnson Ltd., on behalf of the Marketing Authorisation Holder McNeil Products Limited, is recalling all unexpired stock of the above products. This follows a Europe-wide review of the safety and efficacy of all domperidone products which has resulted in the conclusion by the UK Commission on Human Medicines (CHM) that products containing domperidone no longer meet the requirements for supply with legal status ‘P’ (i.e. in a pharmacy without prescription, under the supervision of a pharmacist).

Remaining stocks of the above products should be quarantined.

Pharmacists and wholesalers will be contacted directly by Johnson and Johnson Ltd. with details of the returns process. Please wait for instructions from Johnson and Johnson Ltd. before returning any stock. If you have stock of the above products and have not heard from the company within 10 days of the date on this Drug Alert or if you have returns enquiries after reading the instructions please contact Johnson and Johnson Ltd. Pharmacy Sales Support on 0808 238 978

For Details CLICK HERE