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Association of anxiolytic drugs with Torsade de Pointes: a pharmacovigilance study of the Food and Drug Administration Adverse Event Reporting System.
J Pharm Policy Pract
September 2024
School of Medical and Life Sciences, Sunway University, Sunway City, Malaysia.
Article Synopsis
- This study investigated the link between anxiolytic drugs and the occurrence of Torsade de Pointes (TdP), a type of heart arrhythmia, using data from the FDA's Adverse Event Reporting System (FAERS) over a 30-year period.
- Researchers identified 260 cases of TdP linked to anxiolytics and employed various data-mining algorithms to analyze the risk associated with these drugs.
- The findings revealed six new signals of TdP risk linked to specific drugs, notably showing bromazepam and midazolam as the highest risk, while urging the need for more rigorous clinical studies to ensure patient safety.
When self-administration with counterfeit or mislabeled medicine is suspected, comprehensive laboratory analysis should be preferred over immunoassay screening to avoid false negative results. Carisoprodol, which was formerly a popular muscle relaxant drug in many countries, has reappeared on illegal drug markets, and may cause an itching, purple-colored rash, even after a single dose.
View Article and Find Full Text PDFCarisoprodol Single and Multiple Dose PK-PD. Part II: Pharmacodynamics Evaluation Method for Central Muscle Relaxants. Double-Blind Placebo-Controlled Clinical Trial in Healthy Volunteers.
J Clin Med
February 2022
Clinical Pharmacology Department, Hospital Clínico San Carlos, IdISSC, 28040 Madrid, Spain.
Centrally acting skeletal muscle relaxants (CMR) such as carisoprodol are used to treat acute, painful musculoskeletal conditions, though its precise mode of action has not been characterized. A double-blinded, placebo-controlled, randomized clinical trial was designed to evaluate the pharmacokinetics-pharmacodynamics (PKPD) of CMR after single (350 mg), double (700 mg), and multiple doses (up to 350 mg/8 h, 14 days) of carisoprodol. Muscular (Electromyogram-EMG, muscular strength dynamometry), central (sedation), and tolerability (psychomotor activity test, adverse events) parameters, as well as withdrawal symptoms, were evaluated.
View Article and Find Full Text PDFSingle and Multiple Dose PK-PD Characterization for Carisoprodol. Part I: Pharmacokinetics, Metabolites, and 2C19 Phenotype Influence. Double-Blind, Placebo-Controlled Clinical Trial in Healthy Volunteers.
J Clin Med
February 2022
Pharmacology & Toxicology Department, Facultad de Medicina, Universidad Complutense de Madrid, 28040 Madrid, Spain.
Carisoprodol was authorised in 1959 without a full pharmacokinetic-pharmacodynamic (PK-PD) characterisation. We designed a crossover, double-blind, placebo-controlled, randomized clinical trial to characterize the PKs of carisoprodol and its main active metabolite, meprobamate, after single (350 mg), multiple (350 mg/8 h, 14 days), and double (700 mg) doses of carisoprodol. Thirteen healthy volunteers were enrolled.
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