The Scottish Medicines Consortium (SMC) has issued its monthly advice on new medicines.
Sitagliptin (Januvia®) has been accepted for restricted use as monotherapy to improve glycaemic control in patients with type 2 diabetes mellitus who are inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance.
Ketoprofen/omeprazole (Axorid®) has been accepted for the symptomatic treatment of rheumatoid arthritis, ankylosing spondylitis and osteoarthritis in patients with a previous history or who are at risk of developing NSAID associated gastric ulcers, duodenal ulcers and gastroduodenal erosions in whom continued treatment with ketoprofen is essential. This review also notes that other NSAIDs can be co-prescribed with proton pump inhibitors at lower cost.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
Clinical Knowledge Summaries (CKS) has been updated in July 2010 for the following clinical areas:
Action: Clinicians who see patients with any of these conditions may find the new and updated information useful when reviewing current clinical practice.
The European Medicines Agency has announced that it has started a review to determine whether new data on the risk of cardiovascular problems have an impact on the benefit-risk profile.
Rosiglitazone is available in the European Union as a single agent (Avandia®) and also in combination with metformin (Avandamet®) and glimepiride (Avaglim®).
In 2008 a similar review concluded that the benefit-risk profile remained positive but added new warnings to the product literature. The new warnings advised that clinicians must not use rosiglitazone in patients with acute coronary syndromes and should avoid use in patients with established ischaemic heart disease or peripheral vascular disease. This review may result in no change or in another change, revocation or suspension of the product licence.
Action: Clinicians should be aware of this review. The results of this review may lead to a product licence change.
The Chief Medical Officer at the Department of Health has reissued (PDF) an amended to colleagues within the NHS to provide details of the recommended influenza immunisation programme for 2010/11.
The letter has been reissued to correct an error around the age below which children that have not previously received a seasonal influenza vaccine should receive two doses of vaccine. The advice set out in the Joint Committee on Vaccination and Immunisation (JCVI) statement and the professional letter is for those under 12 years of age but the previous influenza Green Book chapter indicates below 13 years of age (as in previous years).
Action: Clinicians should be aware of this amendment and assess if the changes impact on planning to date.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for July 2010 (PDF).
This issue contains drug safety advice relating to the risk of accidental overdose with intravenous paracetamol (Perfalgan®). While this product is not likely to be widely used in primary care, clinicians should be aware of the risks and take precautions if prescribing this item.
This issue also informs readers that patient information about the Yellow Card Scheme is now available in 11 languages other than English.
The Stop Press section contains a reminder that orciprenaline sulphate (Alupent®) will be withdrawn at the end of September 2010. A recent review found that this product to be less effective and associated with a higher incidence of side effects when compared to more selective beta2-agonists.
Action: Clinicians will find this publication to be a useful review of current issues in drug safety.