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Safety warnings from Aifa on four medicines

The Italian Medicines Agency has implemented 4 warnings, relating to the safety of as many medicines, launched by the Prac, the EMA's pharmacovigilance risk assessment committee. The first is a provision for the suspension of the marketing authorizations of infusion solutions containing hydroxyethyl starch, used for the management of hypovolemia and hypovolemic shock in critically ill patients and, in particular, in patients with sepsis because, following a review of the available evidence, the Prac concluded that the benefits no longer outweigh the risks. There are also important measures to minimize the safety risks related to codeine-containing medicines when used for pain relief in children: they should only be used for the acute treatment of moderate pain above 12 years of age and only if they cannot be replaced with other painkillers such as paracetamol or ibuprofen, due to the risk of respiratory depression. Also, codeine should not be used in any minors undergoing surgery to have their tonsils or adenoids removed for obstructive sleep apnea, as these patients are more susceptible to breathing problems, nor in children with associated with respiratory problems. Limitations of use also for oral medicines and flupirtine-based suppositories: they should only be used for the treatment of acute pain in adults who cannot use other painkillers; treatment should not exceed two weeks. Patients should have liver function monitored every week and treatment should be stopped if there are signs of liver problems. Flupirtine must not be used in patients with pre-existing liver disease or who are abusing alcohol, as well as in patients taking other medicines that cause liver problems. Finally, the review of the painkiller diclofenac concluded that the effects on the heart and circulation when administered systemically are similar to those of selective COX-2 inhibitors, particularly when used at high doses (150 mg/day). and for long-term treatment. The benefits of diclofenac still outweigh the risks, however, measures already in place for COX-2 inhibitors should be applied to minimize the risk of arterial thromboembolic events.

June 18, 2013 – DoctorNews33




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Fedaiisf Federazione delle Associazioni Italiane degli Informatori Scientifici del Farmaco e del Parafarmaco