MHRA alert: chlorhexidine risk of anaphylaxis
25th October 2012
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued an alert for products or medical devices containing chlorhexidine following reports of anaphylaxis. Examples of products which contain chlorhexidine are: antiseptic creams, wipes, cleansers and skin preparations; antiseptic mouthwashes, toothpastes and dental implants; eye drops and contact lens solutions; antiseptic lozenges and throat sprays; urinary catheters; central venous catheters; and antimicrobial dressings.
The following advice has been given:
• be aware of the potential for an anaphylactic reaction to chlorhexidine
• ensure that known allergies are recorded in patient notes
• check the labels and instructions for use to establish if products contain chlorhexidine prior to use on patients with a known allergy
• if a patient experiences an unexplained reaction, check whether chlorhexidine was used or was impregnated in a medical device that was used
• report allergic reactions to products containing chlorhexidine to the MHRA.
NICE issues denosumab costing template
24th October 2012
The National Institute for Health and Clinical Excellence (NICE) has published a costing template to accompany its guidance on denosumab for preventing skeletal-related events in adults with bone metastases from solid tumours (TA 256).
Liverpool Care Pathway consensus statement
18th October 2012
Over 20 organisations have signed a consensus statement in support of the Liverpool Care Pathway for the dying patient, including professional bodies, third sector organisations, disease specific charities and organisations representing care homes, hospices, social services and palliative care specialists.
Metolazone discontinued
18th October 2012
Metolazone tablets (Sanofi Aventis) have been discontinued by the manufacturer in the UK and supplies are almost exhausted. There is currently no other supplier of metolazone tablets in the UK. The British Society for Heart Failure (BSH) has advised switching patients from metolazone to bendroflumethiazide when a patient's supplies run out, at a dose of 2.5 mg, increasing to 5mg, if indicated.
It is thought that generic manufacturers may step into the breach, and metolazone may become available again in the UK in the future.
DTB antidepressant treatment of neuropathic pain
18th October 2012
The latest Drug and Therapeutics Bulletin features part 1 of two articles on the treatment of neuropathic pain and features the use of antidepressants.
NICE evidence summary of tranexamic acid off-label use
17th October 2012
The National Institute for Health and Clinical Excellence (NICE) has published its first evidence summary for the off-label use of products (see our article 04-10-2011). It is for the use of tranexamic acid for significant haemorrhage following trauma.
Change of supplier for Epanutin (phenytoin) capsules
16th October 2012
Flynn Pharma has taken over the manufacture and distribution of Epanutin (phenytoin) capsules in the UK, with the product now marketed as Phenytoin sodium Flynn hard capsules (a generic). Phenytoin sodium Flynn hard capsules are bioequivalent to Epanutin and the capsules have markings and colourings exactly like Epanutin capsules, including still having the marking ‘Epanutin’.
Prescribers are advised to specify the Flynn Pharma product when ordering as pharmacies cannot give the Flynn Pharma product against a prescription for Epanutin and will need to get the prescription amended.
Concern has been raised in the media regarding the significant cost increase from £0.66 for a pack of 28 x 25mg capsules to £15.74.
EMA to review safety of codeine for post-operative pain relief in children
16th October 2012
The European Medicines Agency (EMA) has started its first safety review of a medicine under the new EU rules on pharmacovigilance. It will consider the safety of codeine-containing medicines when used for post-operative pain relief in children. This has been initiated at the request of the UK MHRA on the basis of recent concerns over an increased risk of morphine toxicity when codeine is given in this setting. In particular, a very small number of cases of rare but fatal or life-threatening respiratory depression have been reported in children who are CYP2D6 ultra-rapid metabolisers and were given codeine after surgical removal of the tonsils or adenoids in the treatment of obstructive sleep apnoea.
WHO scoping document available for persistent pain in adults
15th October 2012
A scoping document for guidelines for the pharmacological treatment of persistent pain in adults has been published by the World Health Organization (WHO). Subject to the availability of funding, it is anticipated that these guidelines will be ready by Spring 2015.
Hydromorphone ER 32mg launched in US
12th October 2012
A once daily modified-release hydromorphone 32mg tablet (Exalgo; Mallinckrodt, Hazelwood, MO) has been added to the existing product range of 8mg, 12mg and 16mg modified-release tablets for opioid-tolerant adult patients with moderate to severe chronic pain in the US.
BNF now updated monthly on-line
11th October 2012
BNF 64 (September 2012) is now available. In addition, both the BNF and BNF for Children will now be updated online every month via bnf.org, MedicinesComplete, NHS Evidence and the NICE BNF apps. Print editions of BNF will continue to be published every six months, and BNF for Children annually.
Paediatric morphine doses
11th October 2012
Following the publication of the WHO Guidelines on the Pharmacological Treatment of Pain in Children with Medical Illness (see our article 8-03-2012), WHO have highlighted that the new dosage guidelines for morphine have a more cautious approach and replace the dosage recommendations in the WHO Model Formulary for Children (2010). For specific details see the WHO newsletter and the full guidelines.
Topical capsaicin cream, Cochrane review
10th October 2012
A Cochrane review on the use of low concentration topical capsaicin cream for neuropathic pain has been published.
FDA warn of skin injury with OTC rubefacients
9th October 2012
Rare cases of serious burns on the skin have been reported to the US Food and Drug Administration (FDA) where over-the-counter (OTC) topical muscle and joint pain relievers were applied. The products contained the active ingredients menthol, methyl salicylate, or capsaicin.
Epistatus product description change
3rd October 2012
There has been a change made to the product description of the unauthorized (unlicensed) midazolam product Epistatus (Special Products Limited; 01932 690325) as follows:
Midazolam (Epistatus) 10mg in 1mL Buccal Liquid x 5mL
has been replaced with
Midazolam (Epistatus) 10mg in 1mL Oromucosal Solution x 5mL.
Recent news
- Palliative Care Formulary available via the Association for Palliative Medicine (APM)
- NICE draft guideline for cannabidiol for Dravet syndrome
- NICE draft guideline for cannabidiol for Lennox-Gastaut syndrome
- NICE draft guideline for Cannabis-based medicinal products
- EMA adopts a positive opinion for Epidyolex
- Updated BTS/SIGN asthma guideline published
- Joint position statement on the decision by WHO to withdraw guidance documents
- Neuropathic pain in adults: updated NICE guidance
- BETTER- B breathlessness survey- last chance to complete
- Safer management of controlled drugs
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