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Post-marketing safety of antiseizure medications: Focus on serious adverse effects including drug reaction with eosinophilia and systemic symptoms (DRESS).
Seizure
January 2025
Department of Pharmacy Practice, Auburn University Harrison College of Pharmacy, Auburn, AL 36049, United States.
Purpose: On November 28, 2023, the U.S. FDA issued a Drug Safety Communication, warning that antiseizure medications (ASMs) levetiracetam and clobazam can cause a rare but serious reaction, drug reaction with eosinophilia and systemic symptoms (DRESS).
View Article and Find Full Text PDFDrug Development.
Alzheimers Dement
December 2024
Tokyo Metropolitan Institute for Geriatrics and Gerontology, Tokyo, Japan.
In Japan, the regulatory authority approved the drug in September 2023, and on December 20, it became available for prescription country-wide under the health insurance system. However, there are strict patient, physician, and facility requirements for the prescription of Lecanemab, and various problems are anticipated in its future implementation and widespread use in society. Lecanemab is the first anti-Aβ antibody in Japan, and even dementia specialists do not have sufficient knowledge and experience in its introduction, evaluation of efficacy, and evaluation and handling of side effects.
View Article and Find Full Text PDFPost-marketing safety concerns with lecanemab: a pharmacovigilance study based on the FDA Adverse Event Reporting System database.
Alzheimers Res Ther
January 2025
Department of Pharmacy, Xuanwu Hospital of Capital Medical University, No. 45, Changchun Street, Xicheng District, Beijing, 100053, People's Republic of China.
Background: The safety data of lecanemab in the post-marketing period has yet to be fully investigated in the current literature. We aimed to identify and characterise the safety profile of lecanemab in the post-marketing period.
Methods: We searched and reviewed the reports submitted to the FDA's Adverse Event Reporting System (FAERS).
Use of Causal Framework to Evaluate Effect of Abuse Deterrent Properties of Extended-Release Oxycodone on Tampering in a Real-World Settings.
Pharmacoepidemiol Drug Saf
January 2025
Rocky Mountain Poison & Drug Safety, Denver Health & Hospital Authority, Denver, Colorado, USA.
Purpose: To assess whether exposure to an extended-release (ER) oxycodone with abuse deterrent properties (ADF) reduced tampering of oxycodone in a real-world, postmarket setting to address the thinking behind Category 4 labeling by the FDA.
Methods: Data from an observational cross-sectional study of the general adult population (2022) was used under a causal framework to estimate the confounding-adjusted odds of tampering oxycodone after exposure to two types of ADF ER oxycodone. The tampering behaviors of those who used only single entity immediate-release (SE-IR) oxycodone was used as a comparison.
Pharmacovigilance in Australia: how do adverse event reports from clinicians contribute to medicine and vaccine safety?
Aust Prescr
December 2024
Pharmacovigilance Branch, Therapeutic Goods Administration, Canberra.
Reporting adverse events (adverse drug reactions) associated with medicines and vaccines assists with identifying previously unrecognised side effects and other safety concerns. Reporting adverse events to the Therapeutic Goods Administration is mandatory for sponsors (pharmaceutical companies), and strongly encouraged but voluntary for healthcare professionals and consumers. Adverse events should be reported even when causality is uncertain, as reports may contribute to identification of a safety signal for new or uncommon events.
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