Neuropathic pain consultation

28th June 2013

NICE has published for consultation, its guideline on the pharmacological management of neuropathic pain in adults in a non-specialist setting. Registered stakeholders are able to comment until the deadline of 17 July 2013.

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Diclofenac new contra-indications and warnings

28th June 2013

All formulations of diclofenac, except topical formulations, are now contra-indicated in patients with established:

• ischaemic heart disease
• peripheral arterial disease
• cerebrovascular disease
• congestive heart failure (New York Heart Association [NYHA] classification II–IV).

This follows the findings of a European review, which showed that the cardiovascular risk of diclofenac is equivalent to that of COX-2 inhibitors. Patients with these conditions already taking diclofenac should be switched to an alternative at their next routine appointment. The existing guidance that naproxen and low-dose ibuprofen are considered to have the most favorable thrombotic cardiovascular safety profiles of all non-selective NSAIDs still applies.

MHRA also recommend caution for patients with significant risk factors for cardiovascular events (eg, hypertension, hyperlipidaemia, diabetes mellitus, smoking).

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Abstral SPC updated

28th June 2013

The UK SPC for Abstral (fentanyl citrate) sublingual tablets has been updated. Section 4.2 now states that during titration or the maintenance period, patients should wait at least 2 hours before treating another episode of break through pain with Abstral.

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Lenalidomide authorized for a new indication

27th June 2013

Lenalidomide (Revlimid; Celgene) has been authorized for a new indication in the UK. The updated license now includes treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.

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Hydroxyethyl starch intravenous infusion suspended

27th June 2013

The UK MHRA has suspended all licenses for hydroxyethyl starch (HES) following trial results reporting an increased risk of renal dysfunction and death in critically ill patients compared with crystalloids. All remaining stock of HES products has been recalled.

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Codeine restricted use in children

26th June 2013

The MHRA have restricted the use of codeine in children following the results of a European safety review (see our news item 16-10-2012). Codeine is now contraindicated in:

• all children age 0–18 years who undergo tonsillectomy or adenoidectomy (or both) for obstructive sleep apnoea
• all patients of any age known to be CYP2D6 ultra-rapid metabolisers.

In addition:

• codeine should only be used to relieve acute moderate pain in children older than 12 years and only if it cannot be relieved by other painkillers such as paracetamol or ibuprofen alone. The maximum daily dose should not exceed 240mg taken in divided doses up to four times a day at intervals of no less than 6 hours. It should be used at the lowest effective dose for the shortest period and for a maximum of 3 days
• codeine is not recommended for use in children whose breathing might be compromised, including those with: neuromuscular disorders; severe cardiac or respiratory conditions; upper respiratory or lung infections; multiple trauma; or extensive surgical procedures. Morphine toxicity may be increased in these settings
• codeine should not be used by breastfeeding mothers because of potential harm to the baby via the breast milk.

The regulatory authorities in the USA and Canada have issued similar restrictions and warnings.

MHRA advice

FDA advice

Health Canada advice 

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Ketorolac 10mg tablets discontinued in UK

25th June 2013

Ketorolac 10mg tablets (Toradol; Roche) have been discontinued in the UK due to low demand. There are now no oral formulations of ketorolac available.

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Ondansetron injection SPC updated

25th June 2013

The UK SPC for ondansetron injection (Zofran; GlaxoSmithKline) has been updated. Section 4.2 now states that repeat dosing should be a minimum of 4 hours apart. A new maximum single dose of 8mg has been specified for patients aged above 75 years, which should be given over 15min diluted in 50-100mL of compatible infusion fluid.

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FDA approves denosumab for giant cell tumour of the bone

18th June 2013

The US Food and Drug Administration has approved denosumab (Xgeva; Amgen, California) for giant cell tumour of the bone in adults and adolescents, whose bones have matured, where the tumour is unresectable or likely to result in severe morbidity.

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