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 Based upon this unfavourable benefit-risk profile the product will be withdrawn next year.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.
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