Thalidomide risks highlighted in latest Drug Safety Update
Antithrombotic prophylaxis should be administered for at least five months in patients starting thalidomide treatment, according to the latest issue of Drug Safety Update, published by the Medicines and Healthcare products Regulatory Agency.
The update highlights global postmarketing data that suggest that approximately one third of all reports of thromboembolic reactions associated with thalidomide are arterial. Of these, most are myocardial infarction and cerebrovascular events (54.2 per cent and 19.8 per cent, respectively) with the evidence indicating that the risk of arterial thrombotic and thromboembolic reactions is greatest during the first five months of therapy.
“Action should be taken to minimise all modifiable risk factors for thromboembolic events (eg, smoking, hypertension and hyperlipidaemia),” the update states.
The July issue of the DSU also advises prescribers that dexrazoxane is now contraindicated for use in children and adolescents up to 18 years of age and that use is restricted to adults with advanced or metastatic breast cancer who have previously received a minimum cumulative dose of 300mg/m2 doxorubicin or 540mg/m2 epirubicin. The change in dexrazoxane’s licensed indications follows a safety review by the European Medicines Agency.
In addition, the update reports that the suspension of marketing authorisations for Octagam (intravenous human normal immunoglobulin 5 per cent and 10 per cent) has been lifted following advice from the European Medicines Agency’s Committee for Medicinal Products for Human Use.
Citation: The Pharmaceutical Journal URI: 11080601
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