The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for March 2013 (PDF).
This issue contains drug safety advice informing clinicians that dabigatran (Pradaxa®) is now contraindicated in patients with prosthetic heart valves requiring anticoagulant treatment related to their valve surgery due to an increased risk of thrombosis and bleeding events.
This section also notes that aqueous cream may cause local skin reactions, such as stinging, burning, itching, and redness. This seems to be linked with use as a leave on emollient, particularly in children, when the product contains sodium lauryl sulphate. In cases where irritation occurs it is recommended to use an alternative emollient that is free from sodium lauryl sulphate.
Finally, this section notes that there have been reported cases of toxin spread with botulinum toxin type B (Neurobloc®) that have mostly occurred with off-label use. It is recommended that usage should adhere to the licensed indication and that all patients are warned of the signs and symptoms of toxin spread.
This issue also contains information about a new learning module on benzodiazepines. The module covers adverse events, factors that raise the risk of adverse events and how the risk can be reduced.
Action: Clinicians will find this publication to be a useful review of current issues in drug safety.
The National Institute of Health and Clinical Excellence (NICE) has published new guidance for the month of March 2013. This month there is one clinical guideline that impacts upon primary care.
The Hyperphosphataemia in chronic kidney disease guideline offers evidence-based advice on the care of adults, children and young people with stage 4 or 5 chronic kidney disease (CKD) who have, or are at risk of, hyperphosphataemia. It contains recommendations for the dietary management of hyperphosphataemia and the use of phosphate binders.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Bimatoprost single-dose eye drops (Lumigan UD®) has been accepted for restricted use for the treatment of elevated intraocular pressure in chronic open-angle glaucoma and ocular hypertension in adults. Use is restricted to patients who have proven sensitivity to the preservative benzalkonium chloride.
Ingenol mebutate gel (Picato®) has been accepted for use in the treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis in adults.
Rivaroxaban (Xarelto®) has been accepted for use in the treatment of pulmonary embolism (PE), and prevention of recurrent deep vein thrombosis (DVT) and PE in adults. It was noted that this recommendation is based upon treatment durations of 3, 6 or 12 months and that cost-effectiveness of indefinite treatment has not been demonstrated.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
JAMA Internal Medicine (formerly the Archives of Internal Medicine) has published the results of an observational study that aimed to assess the relationship between sleep medication use and injurious falls in nursing home residents.
The study review data for 15,528 patients who were long stay residents in nursing homes in America with a documented hip fracture between July 2007 and December 2008. The patients were reviewed for exposure to non-benzodiazepine hypnotic drugs before the hip fracture with 1,715 (11.0%) of participants being dispensed such a medication. The risk of hip fracture was elevated in users of non-benzodiazepine hypnotic drugs compared to non-users (OR 1.66, 95% CI 1.45-1.90).
The association was also stronger for new users of non-benzodiazepine hypnotic drugs (OR 2.20, 95% CI 1.76-2.74), those with moderate to severe cognitive impairment compared to mild impairment (OR 1.86 versus 1.43, P=0.06) and those who require full assistance with transfers (OR, 2.02 versus 1.43, P=0.02).
The authors conclude that, "caution should be exercised when prescribing sleep medications to nursing home residents".
The authors note some limitations in this study. The analysis did not include assessment of the drug dose used or any impact of traditional benzodiazepines. Also, the severity and impact of the insomnia on hip fracture risk could not be separated from drug use in the analysis.
Action: Clinicians should be aware of this analysis. While the findings are not surprising they provide a reminder to use hypnotics cautiously in those at higher risk of falling.
The product license for Fostair® (beclometasone and formoterol) pressurised metered dose inhaler (pMDI) has been updated with a new indication to allow use as maintenance and reliever therapy.
The Summary of Product Characteristics advises that patients can take one inhalation of the inhaler regularly twice daily for maintenance and then take up to six additional inhalations as needed in response to symptoms.
Symbicort® (budesonide and formoterol) dry power inhalers (DPI) are already licensed in this way. The license extension for Fostair® now gives clinicians and patients a choice of delivery device (pMDI or DPI).
Action: Clinicians should be aware of the license extension. Patients who prefer pMDI devices may find this product more acceptable.
Thanks to Kevin Ashworth for highlighting this information