British guideline on the management of asthma updated

28th October 2014

The British guidelines on the management of asthma (SIGN 141), produced jointly by the British Thoracic Society (BTS) and Scottish Intercollegiate Guidelines Network (SIGN) have been updated.

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FDA approved naloxegol for opioid-induced constipation

23rd October 2014

The US Food and Drug Administration (FDA) has approved naloxegol (Movantik; Astra Zeneca) a peripherally acting opioid antagonist, for the treatment of opioid-induced constipation in adults with chronic non-cancer pain.

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Cochrane review: codeine, alone and with paracetamol for cancer pain

23rd October 2014

A Cochrane review on the use of codeine, alone and with paracetamol for cancer pain (CD006601) has been published in full on-line.

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Cochrane review: desipramine for neuropathic pain in adults

23rd October 2014

A Cochrane review on the use of desipramine for neuropathic pain in adults (CD011003) has been published in full on-line.

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Dexamethasone 4mg/mL injection changes

21st October 2014

Dexamethasone injection 4mg/mL (Organon) has been acquired by Aspen pharmaceuticals. They have reformulated the product and it now contains 3.8mg/mL dexamethasone, available as a 1mL vial, which requires storage in a fridge.

The other dexamethasone injectable formulations in the UK are 3.3mg/mL (Hameln and Hospira), available as 1mL glass ampoules and do not require refrigeration.

These changes have significant implications for prescribing, administration and storage, with potential further risks for confusion and error above those already ready present due to the different dexamethasone salts.

MHRA has highlighted the issues in the October 2014 Drug Safety Update and UKMI has produced a safety assessment report summarizing the changes, the differences between the products and the potential next steps.

MHRA Drug Safety Update

UKMI product safety assessment (4 November 2014 an updated version is now available click here)

Dexamethasone 3.8mg/mL SPC

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Tegretol chewtabs discontinued in UK

20th October 2014

Novartis is discontinuing carbamazepine 100mg and 200mg chewable tablets (Tegretol Chewtabs) due to the closure of the UK manufacturing site. The existing stocks of 200mg tablets are expected to be depleted by end of October 2014 and 100mg tablets by May 2015.

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New indication for methylnaltrexone in USA

14th October 2014

The US Food and Drug Administration has approved subcutaneous methylnaltrexone injection (Relistor; Salix Pharmaceuticals) for the relief of opioid-induced constipation in adults with chronic non-cancer pain. This is in addition to the existing indication of opioid-induced constipation in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient.

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Nitrofurantoin contra-indications updated

14th October 2014

The guidance for using nitrofurantoin in renal impairment has changed. Nitrofurantoin is now contra-indicated in patients with an estimated glomerular filtration rate (eGFR) of <45mL/min/1.73m². However, a short course (3 to 7 days) may be used with caution in certain patients with an eGFR of 30−44 mL/min/1.73m².

Previously nitrofurantoin was contra-indicated in patients with a creatinine clearance of <60mL/min. The evidence for this has been reviewed by the MHRA in the context of increasing antibiotic resistance and the increasing risk of clostridium difficile colitis with the use of alternative broad-spectrum antibiotics. New evidence supports the revised contra-indication. Further information can be found in the MHRA Drug Safety Update.

MHRA Drug Safety Update

Nitrofurantoin SPC

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SMC accepts capsaicin patch

14th October 2014

The Scottish Medicines Consortium has accepted capsaicin patch (Qutenza) for restricted use within NHS Scotland for the treatment of peripheral neuropathic pain in non-diabetic adults either alone or in combination with other medicinal products for pain. It must only be used in patients who have not achieved adequate pain relief from, or have not tolerated, conventional first and second-line treatments.

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Denosumab updated SPC and information on ONJ and hypocalcaemia

8th October 2014

The UK MHRA has sent out updated information for health professionals to minimise the risk of osteonecrosis of the jaw (ONJ) and hypocalcaemia for both UK formulations of denosumab (Xgeva^® and Prolia^®; Amgen). The UK SPCs have been updated in line with these recommendations.

In addition, denosumab (Xgeva^®) is now indicated for the treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

Xgeva SPC

Xgeva health professional letter

Prolia health professional letter

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Buscopan and baclofen confusion

8th October 2014

UK Medicines Information (UKMI) has highlighted the risk of confusion between Buscopan^® 10mg tablets (hyoscine butylbromide) and baclofen 10mg tablets, following numerous reported medication errors. The majority of errors occurred whilst dispensing although some have occurred whilst prescribing or administering. Recommendations on managing this risk have been made in a product safety assessment report.

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Diclofenac dose reduced in Canada

7th October 2014

Health Canada has reduced the maximum daily dose of diclofenac tablets and suppositories to 100mg/day following a safety review. In addition, diclofenac is not recommended in patients with pre-existing cardiovascular disease (CVD) or cerebrovascular disease, or presenting risk factors for CVD. The review was undertaken following the publication of the study in 2013 (Bhala N et.al Lancet 382:769-79) which indicated that the cardiovascular risks of high dose diclofenac were comparable to COX-2 inhibitors.

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Zolpidem updated SPC

7th October 2014

Strengthened warnings regarding the risk of drowsiness and reduced driving ability, use in the elderly and in liver impairment have been added to the zolpidem SPC. This follows a European review and an MHRA Drug Safety Alert highlighting these risks earlier in the year.

The changes include advising patients:

• not to re-administer the dose during the same night
• not to drive, operate machinery, or work at heights until at least 8 hours after taking zolpidem and if they are still drowsy
• not to take zolpidem with alcohol, illicit drugs, or other central nervous system suppressants

In addition, a maximum of 5mg at night is recommended for people with liver impairment and the elderly.

Zolpidem SPC

MHRA Drug Safety Update

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Electronic prescribing for controlled drugs - DH consultation

2nd October 2014

The UK Department of Health (DH) has published a consultation document on proposals for electronically prescribing Schedules 2 and 3 CDs in both the NHS and privately. The consultation closes on 9 October 2014; responses can be made on-line or via a response form, both available on the DH website.

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