Selected items from the News and Latest Additions sections of www.palliativedrugs.com, the world’s leading palliative care website.
Safety updates
Codeine restricted use in children
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 0–18 years undergoing tonsillectomy or adenoidectomy (or both) for obstructive sleep apnoea
- all patients of any age known to be CYP2D6 ultra-rapid metabolizers.
In addition, codeine:
- should only be used to relieve acute moderate pain in children older than 12 years when other painkillers such as paracetamol or ibuprofen are inadequate. It should be given in divided doses up to four times a day at intervals of no less than 6h and used at the lowest effective dose for a maximum of 3 days. The maximum daily dose should not exceed 240mg/24h
- is not recommended for use in children whose breathing might be compromised (e.g. those with neuromuscular disorders; severe cardiac or respiratory conditions; upper respiratory or lung infections; multiple trauma; or extensive surgical procedures) as the risk of morphine toxicity may be increased
- should not be used by breastfeeding mothers because of potential harm to the baby via the breast milk.
For more information, click here. The regulatory authorities in the USA and Canada have issued similar restrictions and warnings.
Diclofenac new contra-indications and warnings
All formulations of diclofenac, except topical formulations, are now contraindicated 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 (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking). For more information, click here.
Hydroxyethyl starch intravenous infusion suspended
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. For more information, click here.
Drug updates
Ketorolac 10mg tablets discontinued in UK
Ketorolac 10mg tablets (Toradol; Roche) have been discontinued in the UK due to low demand. There are now no oral formulations of ketorolac available.
Abstral SPC updated
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 2h before treating another episode of breakthrough pain with Abstral.
FDA approves denosumab for giant cell tumour of the bone
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 not resectable or likely to result in severe morbidity.
Lenalidomide authorized for a new indication
Lenalidomide (Revlimid; Celgene) has been authorized for a new indication in the UK. The updated SPC 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.
Hot topics
Neuropathic pain consultation
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. For more information, click here.
Latest additions
PCF updated monographs
The online Palliative Care Formulary (PCF) is being continually updated. The following monographs have been updated during June 2013 and supersede those in the publication of the 4th edition of the Palliative Care formulary (PCF4). They can be accessed from the formulary section of the website:
Chapter 5: Weak opioids (minor amendment)
Chapter 5: Codeine phosphate (minor amendment)
Chapter 5: Strong opioids
Chapter 5: Buprenorphine and Quick Prescribing Guide: Use of transdermal buprenorphine
Chapter 7: Systemic corticosteroids (minor amendment)
Chapter 7: Thalidomide
Chapter 9: Potassium (no changes)
Chapter 9: Magnesium
Appendix 2: Taking controlled and prescription drugs to other countries
For a full list of all the monographs updated since the publication of PCF4, (over 50) click here.
PCF4 2nd reprint changes
We would like to thank members for their support which has seen the original and first reprint of PCF4 sell out. In preparing for the 2nd reprint, we have made some minor changes to spelling and formatting in addition to the following changes and clarifications to the text. For full details, click here. We recommend that you amend your copy accordingly. All necessary changes have already been made on the website.
The changes made for the 1st reprint in January 2012 have already been made available and can be accessed from below, along with a list of those monographs that have been updated on the website since PCF4 publication.
We endeavour to achieve the highest levels of accuracy in the text and are always grateful for your feedback (hq@palliativedrugs.com).
Prepared by Sarah Charlesworth and Andrew Wilcock