The National Electronic Library for Medicines has published a fact sheet of supplementary information used by NHS Direct staff when advising about the swine 'flu vaccinations.
The fact sheet contains information in areas such as indications, contraindications, warnings and cautions, adverse effects and details about the vaccination programme.
The reference section provides links to other key resources including the European Medicines Agency portal. This website contains information about the medicines for pandemic influenza (H1N1) including the Summary of Product Characteristics (SPCs) for the three currently licensed vaccines available in Europe (Celvapan®, Focetria®, Pandemrix®) and antivirals (Tamiflu®, Relenza®).
Action: Clinicians will find plenty of useful information in these resources.
The Drugs and Therapeutics Bulletin has published a review of the available evidence for aspirin in the primary prevention of cardiovascular disease (CVD) and concluded that use in this way is unjustified. This advice has been reported in the general media (BBC).
This review considers the recommendations made in various current guidelines and the historical evidence base in comparison to more recent research including the analysis conduct by the Antithrombotic Trialists’ Collaboration and published in the Lancet earlier this year.
A gender specific analysis that is considered found an absolute benefit of 4 cardiovascular events prevented in 1,000 women and 3 prevented in men over a 6.4 year period. This benefit was offset by 2.5 additional bleeding events per 1,000 women and 3 events in men.
These same data can be expressed in terms of number needed to treat (NNT) to prevent a cardiovascular event and number needed to treat to cause a harm (NNH) of a bleeding event. In women the NNT is 333 and the NNH is 400 while in men the figures are 270 and 303 respectively.
The authors of this review conclude that, "the currently available evidence does not justify the routine use of low-dose aspirin for the primary prevention of CVD in apparently healthy individuals, including those with elevated blood pressure or diabetes". They recommend reviewing patients currently taking aspirin for primary prevention and advise against starting any new patients on primary prevention treatment with aspirin.
Action: Clinicians should be aware of this review and the media coverage it has generated. The balance of risk and benefit of aspirin in primary prevention appears to be a very fine line and continued use appears unjustified.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for November 2009 (PDF).
This issue contains drug safety information relating to the risk of osteonecrosis of the jaw and treatment with bisphosphonates. The risk association with oral agents appears to be low but cancer patients and those with poor dental status are advised to have a dental check prior to starting treatment. Regular dental checks, good oral hygiene and reporting of any oral symptoms such as dental mobility, pain, or swelling are advised for patients currently taking treatment.
Clinicians are also reminded of the danger of colchicine in overdosage. Toxicity is more likely in patients with renal or hepatic impairment, gastrointestinal or cardiac disease, and patients at extremes of age. All cases of suspected overdose should be referred for assessment and treatment.
Early notification is also given of the withdrawal of orciprenaline sulphate (Alupent®). A review has found that this drug is less effective than salbutamol and has significantly increased incidence of cardiac side effects, mainly palpitations and tachycardia. Based upon this unfavourable benefit-risk profile the product will be withdrawn next year.
The hot topic discusses an imminent update to the product information for all statins that will add information about recently identified adverse drug reactions (sleep disturbance, memory loss, sexual disturbances, depression, and interstitial pneumopathy). The changes will reflect the positive risk-benefit profile for statins while making patients aware of these side effects.
Finally, the stop press section clarifies the wording in the all of the patient information leaflets for oseltamivir (Tamiflu®) including the paediatric formulations. The leaflet notes that oseltamivir can be taking with aspirin since there is no known interaction between oseltamivir and aspirin. However, this information clarifies that aspirin should not be used in anyone younger than 16 years due to the risk of Reye's syndrome.
Action: Clinicians will find this publication to be a useful review of current issues in drug safety.