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Celecoxib researcher admits fabricating data in 21 articles

31st March 2009

A leading researcher, Dr Scott Reuben, who supported the use of celecoxib, has admitted fabricating data in 21 of his 72 articles indexed by PubMed. A list of these articles, which have now been retracted, can be downloaded from the link below. A full report can be found in the British Medical Journal:
Lenzer J (2009) Prominent celecoxib researcher admits fabricating data in 21 articles. British Medical Journal 338: 618-619.
We have checked though the PCF3 and HPCF USA monographs. We currently have only one reference by this author, which is NOT on the retracted list. The reference appears in the general NSAIDs monograph in chapter 5 and refers to a statement on NSAIDs and bone healing. However, because the original data on which it was based cannot be guaranteed accurate, we are currently investigating alternative supporting evidence for the claims made by this reference and will amend the monograph.

Retraction notice
BMJ reference (registration required)

NICE guideline on diagnosis and treatment of breast cancer

31st March 2009

The UK National Institute for Health and Clinical Excellence (NICE) has issued a new guideline on best practice for the diagnosis and treatment of advanced breast cancer.

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Advance Care Planning national UK guidelines

26th March 2009

National guidelines have been published on advance care planning (ACP) in clinical practice in the UK. The guidelines have been jointly prepared by the British Geriatrics Society, Royal College of Physicians, Royal College of Nursing, Royal College of Psychiatrists, Royal College of General Practitioners, British Society of Rehabilitation Medicine, Alzheimer's Society, Help the Aged and the National Council for Palliative Care and can be downloaded from the Royal College of Physicians website (see link below).

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Dexamethasone 500microgram tablets available in UK

25th March 2009

Dexamethasone 500microgram tablets are now available again as a licensed product in the UK from Chemidex Pharma Ltd (01784 477167, info@chemidex.co.uk ). The tablets can be ordered direct from Movianto Healthcare (code DEX500T) or via mainline wholesalers (pip code 114-6091). The NHS list price is £29.50 per 28 tablets (no minimum order requirement).

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Capsaicin patch (Qutenza) for peripheral neuropathic pain

24th March 2009

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has recommended the granting of a marketing authorisation for capsaicin 179mg cutaneous patch (Qutenza) for the treatment of peripheral neuropathic pain in non-diabetic adults, either alone or in combination with other medicinal products for pain.

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New BNF 57 available

24th March 2009

The latest edition of the British National Formulary (number 57, March 2009) is now available in print and on-line.

BNF website
What's new in BNF57

NPSA rapid response report: Reducing harm from oral bowel cleansing solutions

24th March 2009

The UK National Patient Safety Agency (NPSA) has issued a rapid response report on reducing the risk of harm from oral bowel cleansing solutions. Death and harm from electrolyte abnormalities, dehydration and serious gastro-intestinal problems have been reported following the inappropriate use of oral bowel cleansing solutions (Picolax, Citrafleet , Fleet Phospho-Soda, Klean Prep, Moviprep) prior to surgery and/or investigative procedures.
Harm from these medicines has resulted from lack of clarity in relation to who is authorising the use of these products (and is clinically responsible) and who is authorised to supply these products. The alert sets out action for all organisations in the NHS and independent sector where bowel cleansing solutions are used. Deadline for completed action is 7 September 2009.

Rapid response report on oral bowel cleansing solutions
Supporting information on oral bowel cleansing solutions
NPSA website

ICS statement on unlicensed and off-label prescribing

18th March 2009

The Intensive Care Society (ICS) has issued a consensus statement regarding the use of unlicensed medicines or licensed medicines for unlicensed uses in critically ill patients.

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SMC rejects oxycodone/naloxone prolonged release tablets (Targinact)

18th March 2009

The Scottish Medicines Consortium (SMC) has not accepted, within NHS Scotland, oxycodone/naloxone prolonged release tablets (Targinact) for the treatment of severe pain which can be adequately managed only with opioid analgesics. The SMC stated that "the addition of naloxone to oxycodone did not impair analgesia and improved bowel function when patients were not receiving regular laxative therapy. However the clinical benefit in patients receiving regular laxative therapy is uncertain and the manufacturer did not present a sufficiently robust economic analysis to gain acceptance by SMC".

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ACPA Guide 2009 - Pain Medications & Treatments

12th March 2009

The American Chronic Pain Association (ACPA) has published it's annually updated pain management reference. The 2009 update features expanded coverage of non-drug interventions and complementary therapies.

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Carbamazepine and genetic testing updated SPC

12th March 2009

The UK SPC for all Tegretol preparations (carbamazepine, Novartis Pharmaceuticals) have been updated with the following statement:
'Before deciding to initiate treatment, patients of Han Chinese and Thai origin should whenever possible be screened for HLA-B*1502 as this allele strongly predicts the risk of severe carbamazepine-associated Stevens-Johnson syndrome'.
This follows information from the MHRA in April 2008 (see below).
According to the SPC, if these individuals test positive for HLA-B*1502, carbamazepine should not be started unless there is no other therapeutic option. Patients who test negative, have a low risk of Stevens-Johnson syndrome, although the reactions may still very rarely occur. It is not known whether all individuals of south east-Asian ancestry are at risk due to lack of data. The allele HLA-B*1502 has been shown not to be associated to Stevens-Johnson syndrome in the Caucasian population.

Tegretol Retard SPC
MHRA report

Buprenorphine transdermal patch (BuTrans) updated SPC

10th March 2009

The following sections of the UK SPC for BuTrans 5, 10 and 20microgram/h (buprenorphine transdermal patch, Napp 01223 424912) have been updated as follows:
Section 4.1 The indication has changed from severe pain to moderate pain and now reads "BuTrans is indicated for the treatment of non-malignant pain of moderate intensity when an opioid is necessary for obtaining adequate analgesia. BuTrans is not suitable for the treatment of acute pain."
Section 4.6 A warning that BuTrans should not be used during pregnancy or in women of childbearing potential not using effective contraception has been added.

BuTrans SPC

Adcortyl in Orabase 10g discontinued in UK

10th March 2009

Bristol-Myers Squibb Pharmaceuticals has discontinued Adcortyl in Orabase (triamcinolone acetonide 0.1% in oral paste) 10g tubes as of 31st March 2009 or when current stock is exhausted.
A 5g tube of Adcortyl in Orabase obtainable as a Pharmacy medicine (P) for mouth ulcers will remain available on sale to the public. For further information, contact their Medical Information department on 0800 7311736.

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