NeLM news service
Letters to BMJ on shortgage of lorazepam injection in UK

Reference: BMJ 2011; 343: d5955 (letter), d5962 (company reply)

Source: BMJ

Date published: 22/09/2011 18:50

Summary
by: Yuet Wan

In a letter to the BMJ, the author from Addenbrooke’s Hospital notes that hospitals in his area have been out of stock of IV lorazepam since May 2010. He explains why this drug is preferable to IV diazepam as first line treatment of status epilepticus, and expresses concern about the difficulty in treating patients with status epilepticus and those with agitation, as they are being exposed to drugs that are less likely to be successful and have more common and serious adverse events. He notes that there seems to be no problem with supplies in the US and cannot understand why stocks from there cannot be made available to the UK market. He calls on Pfizer to consider releasing sufficient quantities of IV lorazepam to the UK market soon, calling for a detailed explanation from the company if this is not possible.

 

In reply, Pfizer’s medical director has explained that for several months the company has faced supply issues, which until recently has been produced by a third party manufacturer, Recipharm. On 30 June 2011, it informed Pfizer of the immediate closure of sterile manufacturing activities at its UK site, with the full knowledge of the MHRA and the Department of Health, thus ceasing the manufacture of IV lorazepam for Pfizer. The company states that it is working closely with the appropriate authorities to ensure the long term resupply of this product to UK customers; and stocks are expected in the second quarter of 2013. It is also exploring short term resupply alternatives for customers and patients, and will continue to update the UK regulatory authorities on progress.

 

Pfizer stresses that it does not manufacture or supply IV lorazepam in the US, and any trans-Atlantic supply of the product is subject to UK regulatory requirements and approvals. However, it is aware that third party companies are importing unlicensed medicines on a named patient basis and have made lorazepam available for UK customers in this way.

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