Press release: Discontinuation of Konakion Neonatal (Vitamin K)

Press release.

Date:	16 Jan 2006
Time:	12:49
Subject:	Discontinuation of Konakion Neonatal
Contact:	Press Office 020 7084 3535/3564 or press.office@mhra.gsi.gov.uk Out-of-hours 07770 446 189

Konakion Neonatal, which is a product primarily used to protect babies from vitamin K deficiency at birth, will be discontinued by the manufacturer, Roche Products Limited, on 31st March 2006.

The replacement product available is Konakion MM Paediatric.  This product was previously only licensed to be given by mouth or as an injection to premature babies/babies at special risk.   MHRA has however recently approved the administration of Konakion MM Paediatric to healthy babies by intramuscular injection. When given in this way, the volume of injection is different to that which health professionals will be used to with the old product.

Konakion MM paediatric has also now been licensed to reverse the effects of anticoagulant  therapy in babies and infants, under specialist advice.

Paediatric and obstetric staff should be aware of the prescribing information for the new product. A copy of the manufacturer’s letter to health professionals is available below.

Notes to Editor

1. 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.
2. The manufacturer will be communicating with health professionals about this important change in practice.  A copy of this information is available on the MHRA website at www.mhra.gov.uk , and further information is available from the Roche Drug Information Department on 0800 3281629, or by email to  medinfo.uk@roche.com .
3. The Department of Health recommends that all newborn babies should receive an appropriate Vitamin K regimen, to be agreed with the parents’ informed consent.  If parents have any queries, they should discuss the matter with their doctor or nurse.