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Staggered paracetamol overdose

28th November 2011

There has been a large media interest following the publication of a study in the British Journal of Clinical Pharmacology surrounding the repeated ingestion of slightly greater than recommended doses of paracetamol and the associated increased risk of fatality. See below for further information.

British Journal of Clinical Pharmacology (link to free access full article)
British Journal of Clinical Pharmacology (link to press release)

Update: anti-epileptics monographs

24th November 2011

The anti-epileptics monograph has been updated and published in the Journal of Pain and Symptom Management (JPSM) as a therapeutic review.

Howard P et al (2011) Therapeutic Reviews: Anti-epileptic drugs. Journal of Pain and Symptom Management. 42: 788-804.

This is the 8th therapeutic review in a series in the JPSM. Previous featured monographs include octreotide (July 2010), propofol (September 2010), psychostimulants (November 2010), thalidomide (January 2011), ketamine (March 2011), antipsychotics (May 2011) and loperamide (August 2011). All of these articles are based on those featured in PCF4.

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MHRA update: lenalidomide

18th November 2011

The November 2011 issue of Drug Safety Update from the MHRA features an update about the risk of a second primary malignancy associated with the use of lenalidomide (see our news item 31-05-2011). Clinical trials investigating use of lenalidomide in patients with newly diagnosed multiple myeloma have shown a four-fold increased risk of second primary malignancy (including: haematological malignancies such as acute myeloid leukaemia, Hodgkin’s disease, and B-cell lymphocytic leukaemias; myelodysplastic syndrome; solid tumours; and melanomas). There seems to be a smaller increased risk of second primary malignancy in patients treated with lenalidomide for relapsed or refractory myeloma; the authorised indication.

The MHRA advice continues to be: 

• Use of lenalidomide in unlicensed indications is not recommended unless it takes place as part of a clinical trial

• Patients should be carefully evaluated before and during treatment with lenalidomide using routine cancer screening for occurrence of second primary malignancy and treatment should be instituted as indicated

• Healthcare professionals should report all suspected adverse reactions, including second primary malignancy promptly to us via the Yellow Card Scheme.

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Positive benefit-risk balance of pholcodine-containing cough medicines

18th November 2011

The European Medicines Agency (EMA) has confirmed that the benefits of pholcodine-containing cough medicines outweigh their risks and that these medicines should remain available for the treatment of non-productive (dry) cough in children and adults

A review was initiated following concerns that its use may put people at risk of developing anaphylactic reactions to neuromuscular blocking agents used during surgery. However the EMA Committee for Medicinal Products for Human Use (CHMP) found no firm evidence to substantiate the hypothesis and it also noted that pholcodine-containing medicines have been available for the treatment of non-productive cough in the EU for decades and existing data confirm a positive benefit-risk balance of these medicines.

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Palonosetron capsules launched in UK

18th November 2011

Palonosetron capsules (Aloxi, IS Pharmaceuticals) have been launched in the UK for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults. The dose is 500microgram administered approximately one hour before the start of chemotherapy. The cost of a 500microgram capsule is £56.

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EMA reject appeal for new indication for duloxetine

18th November 2011

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has confirmed its previous negative opinion on the application for a new indication for duloxetine (Cymbalta) for the treatment of moderate to severe chronic somatic pain in patients not taking NSAIDs regularly.

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A review of nabilone for chronic pain management

15th November 2011

The Canadian Agency for Drugs and Technologies in Health (CADTH) has published a review of clinical effectiveness, safety and guidelines for the use of nabilone for chronic pain management. It includes a review of studies for neuropathic pain, cancer pain, non-cancer pain, spasticity-related pain resulting from MS and spinal pain.

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PSNC resource for specials

11th November 2011

The Pharmaceutical Services Negotiating Committee (PSNC) guidance on unlicensed specials and imports has been updated to clarify some common queries based on the new arrangements for reimbursing and endorsing prescriptions for unlicensed specials and imports.

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SMC rejects aprepitant

8th November 2011

Following a resubmission, the Scottish Medicines Consortium (SMC) does not recommend the use of aprepitant (Emend) within NHS Scotland as part of combination therapy, for prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy. The SMC concluded that the clinical and economic analyses submitted by the company were not sufficiently robust to gain its acceptance.

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Single dose fentanyl nasal spray launched in UK

2nd November 2011

NycoMed has launched Instanyl (fentanyl) single-dose nasal spray for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain.  Instanyl single-dose nasal spray is available as a pack of 6 individual child-resistant blisters in 50, 100 and 200microgram strength all costing £35.70 i.e. £5.95 per dose (NHS list price). The single dose blisters do not need priming before use.

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