The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for December 2014 (PDF).
The drug safety section in this issue contains new advice for healthcare professionals when using ivabradine (Procoralan®) in the treatment of symptomatic angina. This medication has been linked with bradycardia, atrial fibrillation and other cardiovascular risks and the following new recommendations have been made.
- Only start ivabradine if the resting heart rate is at least 70 beats per minute
- Do not prescribe ivabradine with other medicines that cause bradycardia, such as verapamil, diltiazem or strong CYP3A4 inhibitors
- Monitor patients regularly for atrial fibrillation. If atrial fibrillation occurs, carefully reconsider whether the benefits of continuing ivabradine treatment outweigh the risks
- Consider stopping ivabradine if there is no or only limited symptom improvement after 3 months
This section also reminds clinicians of the risk of psychiatric disorders with isotretinoin (Roaccutane®). Clinicians are reminded that this medicine should only be prescribed under specialist supervision and that the patients and their family should be warned that the treatment might cause psychiatric disorders such as depression, anxiety, and in rare cases suicidal thoughts. Reporting of such symptoms should be encouraged and appropriate action taken if they arise; simply stopping isotretinoin may not be enough to alleviate symptoms.
Action: Clinicians will find this publication to be a useful review of current issues in drug safety.
Public Health England (PHE) has recently issued advice (PDF) for prescribers on the risk of misuse of pregabalin and gabapentin.
The advice was produced by an expert group and contains suggestions for a balanced and rational use of these medicines. It is noted the majority of patients will use these medicines appropriately but that in some cases they can lead to dependence and may be misused or diverted.
It is suggested that less harmful, alternative drugs can often be first-line treatments for the indicated conditions for which pregabalin and gabapentin are now used, and may be tried preferentially in higher risk settings or in patients who may be more likely to be harmed by the drugs.
Action: Clinicians should be aware of the potential for misuse and diversion of these medicines and the recommendations made to reduce these risks.
The National Institute of Health and Care Excellence (NICE) has published new guidance for the month of December 2014. This month there are four clinical guidelines and one technology appraisal that impact upon primary care.
The Antenatal and postnatal mental health clinical guideline offers evidence-based advice on the recognition, assessment, care and treatment of mental health problems in women during pregnancy and the postnatal period (up to 1 year after childbirth), and in women who are planning a pregnancy.
The Colorectal Cancer clinical guideline offers evidence-based advice on the diagnosis and management of colorectal cancer.
The Pneumonia clinical guideline offers evidence-based advice on the care and management of adults with community- and hospital-acquired pneumonia.
The Dabigatran: deep vein thrombosis and/or pulmonary embolism technology appraisal recommends this treatment as a possible treatment for adults with deep vein thrombosis or pulmonary embolism.
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.
Cholecalciferol 25,000iu solution (InVita D3®) has been accepted for the the prevention and treatment of vitamin D deficiency.
Clindamycin / Tretinoin gel (Treclin®) has been accepted for the for the topical treatment of acne vulgaris when comedones, papules and pustules are present in patients 12 years or older.
Dolutegravir / Abacavir / Lamivudine (Triumeq®) has been accepted for the treatment of Human Immunodeficiency Virus (HIV) infected adults and adolescents above 12 years of age weighing at least 40 kg. It is noted that in patients for whom this combination is appropriate, it offers a single tablet at a lower cost per dose compared with the individual components.
Indacaterol / Glycopyrronium (Ultibro Breezhaler®) has been accepted for use as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). It is noted that for patients for whom this combination is appropriate, this product provides the two ingredients in a single hard capsule at a lower cost than the individual components.
Umeclidinium (Incruse®) has been accepted for use as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). Recent studies of 12 and 24 weeks duration have demonstrated improvements in lung function and symptoms (such as dyspnoea) when compared with placebo. It is noted that umeclidinium is an alternative to other long-acting muscarinic antagonists (LAMAs).
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.