NICE publishes final scope for neuropathic pain guidance
26th May 2009
The UK National Institute for health and Clinical Excellence (NICE) has published the final scope for the guidance for pharmacological management of neuropathic pain in adults in non-specialist settings. The expected publication date of the guidance is March 2010, full details of the process can be found on the NICE website via the links below.
Nystan products discontinued
21st May 2009
Bristol Myers Sqibb (01895 523000) has discontinued Nystatin (Nystan) pessaries, vaginal cream, pastilles, oral tablets, cream and ointment in the UK.
We have confirmed that nystatin (Nystan) 100 000units/mL suspension 30mL remains available.
Change in blood glucose reporting
21st May 2009
From the 1 June 2009 laboratories in the UK will be changing the way in which HbA1c results are reported for people with diabetes. The new measurement will be in mmol/mol instead of %. The equivalent of the current target of 6.5% will be a target of 48mmol/mol. Dual reporting will take place until 31 May 2011 to allow people to become familiar with the new system. Further details for healthcare professionals, laboratory professionals and patients can be downloaded from the links below.
Healthcare professionals leaflet
Laboratory professionals leaflet
Patient information leaflet
MHRA recall seretide 250 evohalers
14th May 2009
The UK Medicines and Healthcare products Regulatory Agency (MHRA) have recalled batch 1183R of seretide 250 evohalers (25microgram of salmeterol xinafoate and 250microgram of fluticasone propionate per actuation) due to the possible presence of counterfeit inhalers in the legitimate supply chain.
Analytical testing of counterfeits, with this batch number, has indicated that some parts of the counterfeit product are genuine. Performance tests have demonstrated that there could be a reduced patient dose if patients have obtained and used a counterfeit inhaler.
FDA Oxycodone tablet shortage in US
14th May 2009
The US Food and Drug Administration have reported that there is a shortage of Oxycodone immediate release tablets (5mg, 15mg and 30mg) due to increased demand following earlier product recalls by other manufacturers.
New UK product droperidol injection
12th May 2009
Droperidol injection is now available again in the UK. Droperidol 2.5mg/ml (Xomolix, ProStrakan 01896 664000) has recently been licensed in the UK for:
• the prevention of nausea and vomiting induced by morphine derivates during post-operative patient controlled analgesia (PCA) in adults and
• prevention and treatment of post-operative nausea and vomiting in adults and, as second line, in children and adolescents.
The SPC is now available from the link below. NHS Cost is £39.40 for 10 x 1ml ampoules.
All formulations of droperidol (Droleptan, Janssen-Cilag) were voluntarily discontinued in the UK in March 2001 due to concerns about use in chronic conditions and it's potential effect on the cardiac QT interval (see MHRA safety warning below). The company also stated that continuation of the injectable form would not be viable.
MHRA alert doxepin 50mg capsules
7th May 2009
Packs of doxepin 50mg capsules (Sinepin, Marlborough Pharmaceuticals 01672 514187) from batch 0901001 have an error in the Braille print on the front of the carton. The Braille embossed on the carton states 'Sinepin 25mg'. This is incorrect and it should state 'Sinepin 50mg'.
All other batches are unaffected. The company has re-worked stocks of batch 0901001 which had not yet entered the supply chain. This stock will be distributed as batch number 0901001A and the Braille is corrected.
Pharmacists are asked to contact any visually impaired customers who may have received the affected batch to make them aware of this issue and should not dispense this batch of product to anyone who relies on Braille for the identification of the product.
MHRA advice: oral salicylate gels in under 16s
7th May 2009
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued new precautionary advice recommending that topical oral pain relief gels containing salicylate salts are not used in those under 16years old.
This is a precautionary measure only and there are no new safety concerns. The advice is being introduced due to a theoretical risk these products could increase the possibility of a child developing Reye's syndrome. The main products affected are Bonjela and Bonjela Cool Mint Gel.
FDA explains proposed opioid prescribing changes
7th May 2009
The US Food and Drug Administration (FDA) is planning a Risk Evaluation and Mitigation Strategy (REMS) that will affect opioid prescribing. This initiative is being introduced to reduce the misuse, abuse, addiction and overdose deaths associated with opioids whilst maintaining access for legitimate patients.
The FDA has produced a series of webinar (audio-with slide) programs to inform healthcare professionals about the issues related to REMS for opioid analgesics. The webinars can be accessed from the FDA link below or the slides alone can be downloaded. Input from stakeholders is requested and a public meeting is being held on 27th and 28th May for broader public interest and participation (see below for more infomation).
FDA opioid REMS webinar and slides
FDA notification of proposed opioid REMS
FDA notice of public meeting
EMEA positive opinion for fentanyl citrate nasal spray
7th May 2009
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has adopted a positive opinion, recommending the granting of a marketing authorisation for fentanyl citrate nasal spray solution (Instanyl) 0.5 mg/mL, 1mg/mL, 2mg/mL, intended for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain.
EMEA negative opinion for extension of pregabalin indication
7th May 2009
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has adopted a negative opinion recommending the refusal of an extension of the indication to the treatment of fibromyalgia in adults experiencing moderate to severe pain, for Lyrica (pregabalin). Lyrica is currently authorised for the treatment of neuropathic pain, epilepsy and generalised anxiety disorder in adults.
Withdrawal of marketing authorisation for epoetin delta
7th May 2009
Shire Pharmaceuticals have voluntarily withdrawn the marketing authorisation for Dynepo (epoetin delta) for commercial reasons.
Flu pandemic planning
5th May 2009
The UK Department of Health (DH) has published the following guidance "Pandemic flu: managing demand and capacity in health care organisations (surge)" which can be accessed from the DH website link below.
The document "Flu pandemic planning: advice for hospices" from Help the Hospices has been updated and can also be downloaded from below.
FDA botulinum toxin safety update
5th May 2009
As the result of an ongoing safety review, the US Food and Drug Administration (FDA) has notified the manufacturers of licensed botulinum toxin products to strengthen warnings in product labelling, and add a boxed warning, about the risk of adverse events when the effects of the toxin spread beyond the site of injection. A Risk Evaluation and Mitigation Strategy (REMS) should also be developed to ensure that the benefits of the product outweigh the risks to the patient. The REMS would include a communication plan and medication guide to provide more information on the risk for distant spread of botulinum toxin effects after local injection, as well as information to explain that botulinum toxin products cannot be interchanged.
The FDA is also requiring manufacturers to submit safety data of use in children and adults with spasticity to assess the signal of serious risk regarding distant spread of toxin effects.
Itraconazole updated SPC
5th May 2009
The UK SPC for itraconazole (Sporanox, Janssen Cilag 0800 7318450) has been updated as follows:
Section 4.4 has been updated with "Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine".
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