Propoxyphene to be withdrawn from US market
23rd November 2010
The US Food and Drug Administration (FDA) has requested that companies voluntarily withdraw propoxyphene products from the US market. They have recommended that healthcare professionals in the US stop prescribing and dispensing medicines containing propoxyphene, on the basis of a review of evidence suggesting that it has significant cardiac toxicity, even at therapeutic doses.
The European Medicines Agency (EMA) recommended that the marketing authorisations for dextropropoxyphene be withdrawn across the European Union in June 2009.
DH care planning information sheets
22nd November 2010
The UK Department of Health (DH) has published a series of information sheets for health care professionals supporting individuals with long term conditions. The information sheets cover a range of topics including care planning, care co-ordination, managing need and assessment of risk, motivating people to self care, goal setting and action planning and end of life care.
Annual evidence update on end of life care
22nd November 2010
The UK NHS Evidence health information resources website (formerly a specialist section of National Library for Health) has produced the first annual update of the evidence on end of life care.
Annual evidence update on head and neck cancer
9th November 2010
The UK NHS Evidence health information resources website (formerly a specialist section of National Library for Health) has produced the first annual update of the evidence in head and neck cancer.
FDA approves duloxetine for chronic pain
9th November 2010
The US Food and Drug Administration (FDA) has approved duloxetine to treat chronic musculoskeletal pain, including discomfort from osteoarthritis and chronic lower back pain.
Oramorph SPC updated
8th November 2010
The UK SPC for Oramorph oral solution 10mg/5mL (morphine sulphate, Boehringer Ingelheim 01344 424600) has been updated to include a specific section for paediatric patients and new information for children aged 13-18years old.
Specific information has also been added on excipients methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) and the amount of ethanol (alcohol) The SPC now states that Oramorph oral solution contains 10vol% ethanol (alcohol). Each dose contains up to 0.81g of alcohol which is equivalent to 20mL beer or 8.3mL wine. The latest SPC can be accessed from the link below.
Actiq SPC updated
5th November 2010
Section 4.2 of the SPC for Actiq (Oromucosal fentanyl lozenge , Flynn Pharma 01462 458 974) has been amended to include additional information on measures to prevent a potential overdose and to further clarify the dosage during titration, maintenance therapy and dose readjustment.
OTC codeine cough liquid preparations should not be used in children
3rd November 2010
The UK Medicines and Healthcare products Regulatory Agency (MHRA) have advised that cough liquid preparations containing codeine should not be available for over the counter purchase (OTC) for use in children and young people under 18years. This follows an evaluation of the benefits and risks of OTC oral codeine liquids for the treatment of cough in children. Further information is contained in the MHRA October 2010 Drug Safety Update which can be accessed from the link below.
NPSA multiple Signal notifications
2nd November 2010
The UK National Patient Safety Association (NPSA) has issued several Signals. Signals are notifications of key risks emerging from reviews of serious incidents reported to the National Reporting and Learning System (NRLS). Signals issued in October include:
Delay in diagnosis and treatment of spinal cord compression
Accurate patient weight
Wrong site nerve block
Haemorrhage following removal of femoral catheters
Non-invasive ventilation
Risk of harm to bariatric patients from delays in treatment
Anticoaguated patients and head injury
Overdose of IV paracetamol in infants and children.
The full details of these notifications can be found on the NPSA Signal website link below.
Generic ibandronic acid
2nd November 2010
The European Medicines Agency (EMA) has recently granted a marketing authorization for generic ibandronic acid (Ibandronic acid Teva) for the prevention of skeletal events in patients with breast cancer and bone metastases (50mg tablets) and for the treatment of osteoporosis in post-menopausal women at risk of developing fractures (150mg tablets).
The Committee for Medicinal Products for Human Use (CHMP) of the EMA has also adopted a positive opinion recommending the granting of a marketing authorization for generic ibandronic acid (Iasibon) for the prevention of skeletal events in patients with breast cancer and bone metastases (tablets and infusion), and for the treatment of tumour-induced hypercalcaemia with or without metastases (infusion).
EMA authorisation Ibandronic acid Teva CHMP opinion on Iasibon
GlucaGen 1mg Hypokit drug alert
1st November 2010
A class 4 medicines defect drug alert has been issued by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for GlucaGen 1mg Hypokit (glucagon 1mg powder and solvent for injection, Novo Nordisk A/S).
It has been found that in an extremely small number of cases, the glass of the powder vial is cracked close to the base so that when the solvent is added, the vial leaks.
Recipients of the affected batches (YW60411 and YW60452, expiry 31/12/2012, first distributed 01/09/2010 and 07/09/2010 respectively) are asked to check their stock for signs of this defect, which is very obvious, and to discard any affected vials. Patients who may have received these batches should also be contacted. Replacement stock from alternative batches is available. For further details see the MHRA website link below.
King's Fund publication on End of Life Care Strategy
1st November 2010
The King's Fund has published "Implementing the End of Life Care Strategy: Lessons from good practice". It is available as a download from the website link below.
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