The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for March 2012 (PDF).
This update contains drug safety information regarding the new contraindications and cautions added to aliskiren (Rasilez®) after a recent study found no benefit and an increased risk of harm when this drug was used in combination with either an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) in patents with type 2 diabetes.
The stop press section informs clinicians that the marketing authorisation (licence) for levothyroxine 100 microgram tablets manufactured by Teva has been suspended due to the potential for reduced efficacy and evidence of manufacturing difficulties. Clinicians should be aware that recent use of this product may result in a change in a patient’s symptoms and TSH status. Other brands of levothyroxine and other strengths from the same manufacturer are unaffected.
This sections also advises that Vigantoletten® and Dekristol® vitamin D (colecalciferol) capsules imported from Germany contain soya oil and arachis (peanut) oil respectively. Osto D2® capsules from Canada and Drisdol capsules® from the USA also contain soya oil. The packaging for these products may not explicitly list these ingredients and usage by susceptible individuals may lead to severe allergic reactions. It is recommended that doctors and pharmacists should check whether patients have any relevant allergies before prescribing or supplying these medicines.
Action: Clinicians will find this publication to be a useful review of current issues in drug safety.