Press release: People with severe allergies advised to see their GP after recall of Anapen adrenaline injector

Press Release

Date:	23 May 2012
Time:	10:00
Subject:	People with severe allergies advised to see their GP after recall of Anapen adrenaline injector.
Contact:	Press Office 020 3080 7651 or press.office@mhra.gsi.gov.uk Out-of-hours 07770 446 189

The Medicines and Healthcare products Regulatory Agency (MHRA) today issued an alert to healthcare professionals and is advising people who suffer from severe allergic reactions to see their GP or clinic as soon as possible to discuss alternative products after Anapen – an adrenaline injector used to treat anaphylactic shock – was precautionary recalled by the licence holder Lincoln Medical Limited.

A potential problem with the speed and delivery of adrenaline by the Anapen injectors was found during development work by the manufacturer Owen Mumford Ltd. No problems with these injectors have been reported by people or healthcare professionals but in the worst case scenario, the injector could fail to deliver adrenaline in an emergency situation when a person has a severe allergic reaction caused by peanuts or other foods, insect bites or stings.

People with the injectors below at home are advised to continue using their Anapen injectors until they can discuss using alternative products with their GP or clinic.

Anapen 500 micrograms in 0.3ml solution for injection in a pre-filled syringe PL 18813/0003
Anapen 300 micrograms in 0.3ml solution for injection in a pre-filled syringe PL 18813/0001
Anapen Junior 150 micrograms in 0.3ml solution for injection in a pre-filled syringe PL 18813/0002

Gerald Heddell, the MHRA’s Director of Inspection, Enforcement and Standards, said:

“This is a precautionary recall and no problems with Anapen adrenaline injectors have been reported by people or healthcare professionals. People should continue to use their existing Anapen injectors until they can obtain an alternative product and they should make an appointment with their GP or clinic as soon as possible to discuss this.”

Notes to Editor

1. The Class 2 drug alert has been sent to healthcare professionals and is available on the MHRA website here: Class 2 Drug Alert (Medicines recall): Lincoln Medical Limited - Anapen 500mcg, 300mcg and Junior 150mcg/0.3ml solution for injection in a pre-filled syringe - EL (12)A/20
2. Patients can call the Anaphylaxis Campaign website helpline on 01252 542029 if they are worried or have urgent questions
3. The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone – the public and healthcare professionals as well as the industry – to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action. www.mhra.gov.uk