The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Atomoxetine (Strattera®) has been accepted for use in the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults as part of a comprehensive treatment programme. They recommend that the presence of symptoms that were pre-existing in childhood should be confirmed.
Ondansetron orodispersible films (Setofilm®) have been accepted for restricted use in nausea and vomiting associated with emetogenic chemotherapy and post-operative nausea and vomiting (PONV). The review notes that generic preparations of ondansetron are available at a lower cost than the proprietary products.
Sodium phenylbutyrate granules (Pheburane®) have been accepted for use as an adjunctive therapy in the chronic management of urea cycle disorders. It is noted that this product provides an alternative to sodium phenylbutyrate tablets at no additional cost but is more expensive than an existing brand of sodium phenylbutyrate granules.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
The manufacturer of mefloquine (Larium®) has written to healthcare professionals with an update on the risk of neuropsychiatric adverse reactions associated with use of this medication.
Mefloquine has been known to potentially cause neuropsychiatric adverse reactions such as abnormal dreams, insomnia, anxiety and depression for some time. Less frequently hallucinations, psychosis, suicide and suicidal thoughts have been reported. Due to the long half-life of mefloquine, such reactions may persist for several months after discontinuation of treatment.
This letter emphasises the importance of promptly stopping treatment in any patient with signs of neuropsychiatric reactions. It is also recommended that patients are advised about the type of symptoms they might experience that are associated with neuropsychiatric reactions and to stop taking the medication immediately and seek medical advice should they arise. To aid this, the letter includes some Patient Alert Cards and a contraindication check list to use before prescribing.
Action: Clinicians should already be aware of the neuropsychiatric reactions associated with mefloquine use. The prescribing aids included with this letter may prove useful in ensuring safer use of mefloquine.
The National Institute of Health and Care Excellence (NICE) has published new guidance for the month of October 2013. This month there in one diagnostic guideline and one public health guideline that impact upon primary care.
The Faecal calprotectin diagnostic tests for inflammatory diseases of the bowel diagnostic guideline recommends that faecal calprotectin testing is made available as an option to help doctors distinguish between inflammatory bowel diseases, such as Crohn’s disease and ulcerative colitis, and non-inflammatory bowel diseases, such as irritable bowel syndrome. It is hoped that this test will help to reduce the number of people with irritable bowel syndrome having unnecessary invasive hospital investigations before their condition is diagnosed. Clinicians will need to check availability of this test with local pathology providers.
The Managing overweight and obesity among children and young people public health guideline makes recommendations on lifestyle weight management services for overweight and obese children and young people aged under 18. This guideline make several recommendations including raising awareness of lifestyle weight management programmes and formal referrals to such programmes.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
MTRAC issued two new Commissioning Support reviews in October 2013. The reviews cover perampanel and zonisamide.
The perampanel (Fycompa®) summary advises that this drug is not suitable for prescribing in primary care for adjunctive treatment of partial seizures in epilepsy. It is recommended that prescribing should occur in a tertiary care setting and notes that patients are likely to receive continued specialist supervision.
The zonisamide (Zonegran®) summary advises that this drug is suitable for restricted prescribing under defined conditions as monotherapy for partial seizures in epilepsy. It is recommended that the treatment is initiated and stabilised by a specialist after which maintenance therapy can be issued in primary care. It is expected that patients would continue to receive follow-up in secondary care.
Action: Clinicians should be aware of these reviews and use the recommendations to guide appropriate use of these medicines in current practice.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for October 2013 (PDF).
This issue contains drug safety advice informing clinicians of updated contraindications and warnings for the newer oral anticoagulants apixaban (Eliquis®), dabigatran (Pradaxa®) and rivaroxaban (Xarelto®). A common set of contraindications have been applied for all three of these agents to include range of clinical conditions where the patient is at significant risk of major bleeding, as well as in combination with other anticoagulant agents. The full contraindications are as follows:
- A lesion or condition, if considered a significant risk factor for major bleeding. This may include:
- Current or recent gastrointestinal ulceration
- Presence of malignant neoplasm at high risk of bleeding
- Recent brain or spinal injury
- Recent brain, spinal, or ophthalmic surgery
- Recent intracranial haemorrhage
- Known or suspected oesophageal varices
- Arteriovenous malformation
- Vascular aneurysms, or major intraspinal or intracerebral vascular abnormalities
- Concomitant treatment with any other anticoagulant agent for example: unfractionated heparin, low molecular weight heparin (such as enoxaparin or dalteparin), heparin derivatives (such as fondaparinux) or oral anticoagulants (such as warfarin). Exceptions are switching of therapy to or from the medicine, or when unfractionated heparin is given at doses necessary to maintain an open central venous or arterial catheter
Clinicians are also reminded to be aware of the contraindications, posology, and warnings and precautions for use specific to each medicine as well as the patient's individual risk factors for bleeding including their renal function (dose adjustment may be required).
Action: Clinicians will find this publication to be a useful review of current issues in drug safety.