Impact of Covid-19 Vaccination on Spontaneous Pharmacovigilance Reporting in France
ConclusionOur study showed a significant impact of the Covid-19 campaign vaccination in the reporting of adverse drug reactions that were not Covid-19 vaccine-related, of roughly 35%. This leads to a loss of information regarding the monitoring of drug safety that could have impacted the system capacity to detect safety signals for drugs other than Covid-19 vaccines. (Source: Drug Safety)
Source: Drug Safety - November 5, 2023 Category: Drugs & Pharmacology Source Type: research
22nd ISoP Annual Meeting “Putting Patients First in Pharmacovigilance: International Perspectives from Global South” 6–9 November 2023 Bali, Indonesia
(Source: Drug Safety)
Source: Drug Safety - November 3, 2023 Category: Drugs & Pharmacology Source Type: research
Proceedings of the International Ambulatory Drug Safety Symposium: Munich, Germany, June 2023
(Source: Drug Safety)
Source: Drug Safety - November 2, 2023 Category: Drugs & Pharmacology Source Type: research
Drug Utilisation Patterns of Alternatives to Ranitidine-Containing Medicines in Patients Treated with Ranitidine: A Network Analysis of Data from Six European National Databases
ConclusionsRanitidine was commonly used prior to referral, but it was subsequently discontinued and replaced primarily with PPIs. (Source: Drug Safety)
Source: Drug Safety - October 31, 2023 Category: Drugs & Pharmacology Source Type: research
Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis
ConclusionsIn this analysis of 4399 guselkumab-treated patients with psoriatic disease followed for 10,787 PYs, guselkumab had a favorable AE profile. AE rates were similar between guselkumab- and placebo-treated patients and were consistent throughout long-term guselkumab treatment and across broad subgroups of patients with psoriatic disease.Clinical Trials RegistrationsClinicaltrials.gov identifiers: NCT01483599, NCT02207231, NCT02207244, NCT02203032, NCT02905331, NCT03090100, NCT02325219, NCT02319759, NCT03162796, NCT03158285, and NCT03796858.Graphical Abstract (Source: Drug Safety)
Source: Drug Safety - October 31, 2023 Category: Drugs & Pharmacology Source Type: research
Drug Utilisation Patterns of Alternatives to Ranitidine-Containing Medicines in Patients Treated with Ranitidine: A Network Analysis of Data from Six European National Databases
ConclusionsRanitidine was commonly used prior to referral, but it was subsequently discontinued and replaced primarily with PPIs. (Source: Drug Safety)
Source: Drug Safety - October 31, 2023 Category: Drugs & Pharmacology Source Type: research
Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis
ConclusionsIn this analysis of 4399 guselkumab-treated patients with psoriatic disease followed for 10,787 PYs, guselkumab had a favorable AE profile. AE rates were similar between guselkumab- and placebo-treated patients and were consistent throughout long-term guselkumab treatment and across broad subgroups of patients with psoriatic disease.Clinical Trials RegistrationsClinicaltrials.gov identifiers: NCT01483599, NCT02207231, NCT02207244, NCT02203032, NCT02905331, NCT03090100, NCT02325219, NCT02319759, NCT03162796, NCT03158285, and NCT03796858.Graphical Abstract (Source: Drug Safety)
Source: Drug Safety - October 31, 2023 Category: Drugs & Pharmacology Source Type: research
Long-Term Real-World Post-approval Safety Data of Multiple Biosimilars from One Marketing-Authorization Holder After More than 18 Years Since Their First Biosimilar Launch
ConclusionsThis is one of the largest reviews of post-approval biosimilar pharmacovigilance data to date by one MAH. The real-world experience of all eight marketed Sandoz biosimilars for up to 18 years demonstrates that Sandoz biosimilars can be used as safely as their respective reference biologics. Therefore, patients and healthcare providers can be confident in the clinical benefit and safety of Sandoz biosimilars. It is reasonable to believe that similar conclusions about safety may be reached for other biosimilars developed and approved to the high standards as are already in place by major health authorities such as...
Source: Drug Safety - October 30, 2023 Category: Drugs & Pharmacology Source Type: research
Acknowledgement to Referees
(Source: Drug Safety)
Source: Drug Safety - October 30, 2023 Category: Drugs & Pharmacology Source Type: research
Long-Term Real-World Post-approval Safety Data of Multiple Biosimilars from One Marketing-Authorization Holder After More than 18 Years Since Their First Biosimilar Launch
ConclusionsThis is one of the largest reviews of post-approval biosimilar pharmacovigilance data to date by one MAH. The real-world experience of all eight marketed Sandoz biosimilars for up to 18 years demonstrates that Sandoz biosimilars can be used as safely as their respective reference biologics. Therefore, patients and healthcare providers can be confident in the clinical benefit and safety of Sandoz biosimilars. It is reasonable to believe that similar conclusions about safety may be reached for other biosimilars developed and approved to the high standards as are already in place by major health authorities such as...
Source: Drug Safety - October 30, 2023 Category: Drugs & Pharmacology Source Type: research
Intravenous Medication Administration Safety with Smart Infusion Pumps in the Neonatal Intensive Care Unit: An Observational Study
ConclusionWe identified the medication errors, which was unique to NICU populations, but no harm to the patients were identified. Most errors occurred due to a lack of compliance of using smart pump technology; therefore, potential exists to maximize safety related to medication administration practices in the NICU through hospital policy change and increasing adherence to appropriate use of smart pump technology. (Source: Drug Safety)
Source: Drug Safety - October 27, 2023 Category: Drugs & Pharmacology Source Type: research
