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La nuova normativa di farmacovigilanza
Le nuove disposizioni di legge in tema di sicurezza dei medicinali promettono di cambiare significativamente la farmacovigilanza
Italiano
Le nuove disposizioni di legge in tema di sicurezza dei medicinali promettono di cambiare significativamente la farmacovigilanza
Le differenze sesso-genere specifiche (preferiamo usare il termine sesso-genere come discusso altrove1) coinvolgono la farmacocinetica e la farmacodinamica2 e riguardano tutti gli xenobiotici,1 riflettendosi sulle interazioni tra farmaci e rimedi botanici, tra farmaci e cibo, eccetera. Storicamente, le donne sono state poco arruolate negli studi clinici e ciò vale anche per gli animali di sesso femminile negli studi preclinici,2 oppure nel caso di arruolamento delle donne il disegno sperimentale non era spesso adatto a individuare le differenze sesso-genere.
Many Canadian jurisdictions are facing decisions about new oral anticoagulants for stroke prevention in patients with atrial fibrillation (the most common type of irregular heartbeat). Although the new drugs are as effective as standard therapy, they are more expensive and little is known about their long-term safety. CADTH’s review led to a recommendation that these drugs be considered second-line options.
Many Canadian jurisdictions are facing decisions about new oral anticoagulants for stroke prevention in patients with atrial fibrillation (the most common type of irregular heartbeat). Although the new drugs are as effective as standard therapy, they are more expensive and little is known about their long-term safety. CADTH’s review led to a recommendation that these drugs be considered second-line options.
Risks associated with this defect could include tissue necrosis in one or more organs that could result in stroke, myocardial infarction, respiratory failure, and loss of renal and hepatic function.
ICD lead malfunction may cause abnormal sensing or pacing, or delivery of inappropriate or no shock therapy, which could result in serious adverse events, including death.
Opioid pain medications such as hydromorphone have life-threatening consequences if overdosed.
Volume leakage and/or disconnection could impact patient ventilation.
Ultra-rapid metabolizers are more likely to have higher than normal amounts of morphine in their blood after taking codeine. High levels of morphine can result in breathing difficulty, which may be fatal.
The deadline for feedback on the draft Environmental Scan report on the Appropriate Utilization of Advanced Diagnostic Imaging Procedures has been extended to September 7, 2012.
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