L'Agenzia Italiana del Farmaco rende disponibili nuove e importanti informazioni su ellaOne (ulipristal acetato) e sorveglianza post-marketing: Registro delle Gravidanze.
Administration of contaminated or otherwise poor quality drug products can result in serious and life-threatening injury or death.
L'Agenzia europea per i
medicinali (EMA) ha avviato una rivalutazione urgente del medicinale per la
sclerosi multipla Zinbryta (daclizumab) in seguito a 7 casi di gravi disturbi
infiammatori a livello cerebrale avvenuti in Germania, tra cui encefalite e meningoencefalite,
e ad un caso avvenuto in Spagna.
Sibutramine and its active metabolites substantially increase blood pressure and/or pulse rate in some patients and may present significant health risks including heart attack, arrhythmia, and stroke.
Delay or inability to deliver a shock to a patient in cardiac arrest or pace a patient’s heart whose heartbeat is too slow could result in serious injury and/or death.
Cracked vials may result in a lack of sterility assurance. Use of or exposure to a non-sterile product may be associated with adverse events such as fever, chills, sepsis or invasive systemic infections in patients.
Prescribers advised to consider using other antibiotics in patients with heart disease.
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