Therapeutic advances in drug safety
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Different strategies have been studied to allow a better characterization of the safety profile of orphan drugs soon after their approval. At the end of the development phases only few data are available because of the small number of subjects exposed to an orphan medicine for the treatment of rare or ultra-rare conditions. As a consequence, the evaluation of the safety profile is limited at the time of the first approval. ⋯ On the other hand it could also cause the loss of some identification of SDRs that would be captured if no database restrictions had been undertaken. Therefore, data subgroup analysis should not be selected as a preferred approach to quantitative signal detection for orphan drugs but rather evaluated as complementary possibly to confirm negatives or to further characterize detected SDRs. Some examples of false negatives originating from quantitative signal detection in EudraVigilance applied to orphan drugs are discussed in this article.
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Review of clinical data on andexanet alfa for the reversal of factor Xa (FXa) inhibitor associated anticoagulation. ⋯ Studies evaluating laboratory parameters for coagulation show that andexanet alfa rapidly neutralizes the anticoagulant effects of apixaban, enoxaparin, edoxaban, and rivaroxaban. Clinical studies show that andexanet alfa improves markers related to coagulation, and reverses major bleeding in healthy volunteers and patients with life-threatening bleeding. Interruption of anticoagulation may result in thromboembolic and ischemic events. The use of andexanet alfa requires close monitoring for signs and symptoms of thromboembolic events, ischemic events, and cardiac arrest. Furthermore, anticoagulation should be resumed following the administration of andexanet alfa as soon as medically appropriate.
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Atypical antipsychotics (AAP) have been associated with reduced duration of delirium in the intensive care setting. However, long-term use of these drugs is associated with significant adverse events, including increased all-cause mortality in the elderly. Inappropriate continuation of AAPs after discharge from the intensive care unit (ICU) is worrisome and needs to be addressed.The aim of this work was to assess the prevalence of continuation of AAPs after hospital discharge and evaluate the associated risk factors. ⋯ Male sex and discharge to a healthcare facility were associated with a higher rate of continuation. Research into practical methods to reduce their continuation upon discharge should be performed to mitigate the long-term risks of AAP administration.
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Patients from residential aged care facilities are commonly exposed to inappropriate polypharmacy. Unplanned inpatient admissions can provide an opportunity for review of complex medical regimens and deprescribing of inappropriate or nonbeneficial medications. The aim of this study was to assess the efficacy, safety and sustainability of in-hospital deprescribing. ⋯ Deprescribing medications during an unplanned hospital admission was not associated with mortality, readmissions, or overall HRQOL.
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Sugammadex is used for the reversal of neuromuscular blockade caused by rocuronium bromide and vecuronium bromide. As part of the post licensing phase of drug development, adverse events related to the use of sugammadex are still being uncovered and being reported. The potential association between sugammadex and adverse events bronchospasm and coronary arteriospasm using a retrospective pharmacovigilance signal analysis was carried out. ⋯ The results of the pharmacovigilance analysis highlight a statistically significant disproportionality signal between sugammadex usage and bronchospasm and coronary arteriospasm adverse events. Physicians need to be aware of these adverse events when using sugammadex. The results of the pharmacovigilance signal analysis highlight a statistically significant disproportionality signal between sugammadex usage and bronchospasm and coronary arteriospasm adverse events. Physicians need to be aware of these adverse events when using sugammadex.