The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for January 2014 (PDF).
This issue contains drug safety advice informing clinicians of new advice and recommendations for several drugs.
A recent trial aimed to assess optimal dosing time for patients undergoing percutaneous coronary intervention (PCI). Some patients were given a split loading dose before and at the time of the PCI while others were given a single loading dose at the time of the PCI. The trial found an increased risk of bleeding but no additional benefit in those who received the split loading dose. In line with the current product license, it is recommended that patients undergoing PCI are dosed at the time of the intervention to minimise the risk of bleeding.
Hepatic injury, including hepatic failure with fatal outcome, has been reported in association with temozolomide (Temodal®). Liver function testing is recommended before starting treatment and also at the mid-point between cycles. Onset may be delayed and even occur have treatment is complete.
Severe skin reactions such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in association with capecitabine. This is a rare (less than 1 in 10,000) but serious occurrence with 20 cases reported in the UK between 2002 and the end of 2013. Treatment should be permanently discontinued in patients who have a severe skin reaction and the reaction should be treated promptly.
As always, serious adverse drug reactions should be reported through the Yellow Card system.
Action: Clinicians will find this publication to be a useful review of current issues in drug safety.
The National Institute of Health and Care Excellence (NICE) has published new guidance for the month of January 2014. This month there are two clinical guidelines and one public health guideline that impact upon primary care.
The Prostate Cancer clinical guideline updates original guidance issued in February 2008. It offers evidence-based advice on the care of men referred to secondary care with suspected or diagnosed prostate cancer, including follow-up in primary care for men with diagnosed prostate cancer.
The Head Injury clinical guideline updates original guidance issued in September 2007. It offers evidence-based advice on the care of children, young people and adults with head injury including recommendations regarding pre-hospital assessment, advice and referral to hospital.
The Behaviour Change: Individual Approaches public health guideline makes recommendations on individual-level interventions aimed at changing health-damaging behaviours related to alcohol, diet, physical activity, sex and smoking among people aged 16 or over. It includes a range of approaches, from single interventions delivered as the opportunity arises to planned, high-intensity interventions that may take place over a number of sessions.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
MTRAC issued a new Commissioning Support review in January 2014. The review covers dapoxetine.
The dapoxetine (Priligy®) summary advises that this drug is suitable for restricted prescribing in primary care for the treatment premature ejaculation. The review notes that the evidence for this treatment is relatively strong but notes that accurate diagnosis of this condition requires referral to a specialist psychosexual health clinic.
Action: Clinicians should be aware of these reviews and use the recommendations to guide appropriate use of these medicines in current practice.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on newly licensed medicines.
Fentanyl citrate (Breakyl®) has been rejected for the treatment of breakthrough pain (BTP) in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain. The manufacturer failed to make a submission.
Saxagliptin / Metformin (Kombogylze®) has been accepted for use in the treatment of type 2 diabetes mellitus in adults as triple oral therapy (in combination with a sulphonylurea) to improve glycaemic control when dual therapy (with metformin and a sulphonylurea), in combination with diet and exercise, does not provide adequate glycaemic control.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
The British Medical Journal has published the results of an observational study that aimed to determine whether patients taking formulations of drugs that contain sodium (soluble, effervescent or dispersible formulations) have a higher incidence of cardiovascular events compared with patients on non-sodium formulations of the same drugs.
The study included data for 1,292,337 UK patients in the Clinical Practice Research Datalink who were prescribed at least two prescriptions of sodium-containing formulations or matched standard formulations of the same drug between January 1987 and December 2010. The primary outcome was a composite of incident non-fatal myocardial infarction, incident non-fatal stroke or vascular death. 61,072 patients who experienced a cardiovascular event were match with controls.
For the primary endpoint the adjusted odds ratio for exposure to sodium-containing drugs was 1.16 (95% confidence interval 1.12 to 1.21). Individually the odds rations were 1.22 (1.16 to 1.29) for incident non-fatal stroke, 1.28 (1.23 to 1.33) for all-cause mortality, 7.18 (6.74 to 7.65) for hypertension, 0.98 (0.93 to 1.04) for heart failure, 0.94 (0.88 to 1.00) for incident non-fatal myocardial infarction, and 0.70 (0.31 to 1.59) for vascular death.
The authors conclude that, "Exposure to sodium-containing formulations of dispersible, effervescent and soluble medicines was associated with significantly increased odds of adverse cardiovascular events compared with standard formulations of those same drugs". They recommend that "Sodium-containing formulations should be prescribed with caution only if the perceived benefits outweigh these risks".
The authors note several limitations in the study including accuracy of information in the database, inability to correct for family history, health behaviours and dietary sodium intake and lack of date on over-the-counter medicine use.
Action: Clinicians should be aware of the association between sodium containing drug formulations and increased cardiovascular events. Use of dispersible, effervescent and soluble medicines should be avoided where this is possible.
Source: Medicines Awareness Weekly email