Results 51 to 60 of about 11,239 (184)

Antiseizure potency and neurotoxicity of the enantiomers of fenfluramine and norfenfluramine in rats and correlations with their concentrations in plasma and brain

Epilepsia, EarlyView.
Abstract Objective Based on the evidence that fenfluramine‐induced anorexia, weight loss, and cardiovascular toxicity are primarily mediated by the d‐enantiomers of fenfluramine and its metabolite norfenfluramine, we investigated pharmacokinetic/pharmacodynamic correlations for the active enantiomers of fenfluramine and norfenfluramine in the rat ...
Yara Sheeni, Dinorah Barasch, Tawfeeq Shekh‐Ahmad, Emilio Perucca, Meir Bialer   +4 more
wiley   +1 more source

Hallucinatory Side Effects of ADHD Drugs

Pediatric Neurology Briefs, 2009
Clinical trial and postmarketing surveillance data for drugs used in treatment of attention deficit hyperactivity disorder were analyzed to determine the frequency of hallucinations and other psychotic side effects, in a study at the US Food and Drug ...
J Gordon Millichap
doaj   +1 more source

Collagen‐membrane‐covered matrix‐associated chondrocyte implantation improves safety over periosteum‐covered MACI for large knee cartilage defects: A real‐world data analysis in the registry study

Knee Surgery, Sports Traumatology, Arthroscopy, EarlyView.
Abstract Purpose This registry study aimed to evaluate the safety and effectiveness of collagen membrane‐covered matrix‐associated autologous chondrocyte implantation (cMACI) versus periosteum‐covered MACI (pMACI) for large knee cartilage defects (Outerbridge III–IV, ≥4 cm²) in the femorotibial and/or patellofemoral joints with a minimum 2‐year follow ...
Yuji Uchio, Ryosuke Kuroda, Yasuo Niki, Katsura Sugawara, Yasuyuki Ishibash   +4 more
wiley   +1 more source

Real‐World Safety and Effectiveness of Glatiramer Acetate in Patients With Multiple Sclerosis: Final Results of Post‐Marketing Surveillance in Japan

Neurology and Clinical Neuroscience, EarlyView.
ABSTRACT Background Glatiramer acetate is an injectable disease‐modifying therapy indicated for multiple sclerosis (MS). Aim To evaluate the real‐world safety and effectiveness of glatiramer acetate for MS in Japan. Methods A prospective, multicenter, observational, all‐case post‐marketing survey was conducted in Japan between November 2015 and March ...
Masaaki Niino, Eriko Hayashi, Mai Itani, Jun‐ichi Kira   +3 more
wiley   +1 more source

Occurrence of Pulmonary Oil Microembolism After Testosterone Undecanoate Injection: A Postmarketing Safety Analysis

Sexual Medicine, 2020
Background: The Aveed Risk Evaluation and Mitigation Strategy program was instituted because of potential risk of pulmonary oil microembolism (POME) and/or anaphylaxis after intramuscular injection of Aveed (testosterone undecanoate), indicated for ...
Alexander W. Pastuszak, MD, PhD, Yiqun Hu, MD, PhD, Jeffrey D. Freid, MD   +2 more
doaj   +1 more source

A British Pharmacological Society Position Statement on Medications in Pregnancy and Lactation

British Journal of Clinical Pharmacology, EarlyView.
Agnesa Mustafa, Cleodie C. Swire, Reya V. Shah, Bernadette Jenner, Rory H. McLean, Muhammad Shamsher Ahmed, Adrie Bekker, Julia Zöllner, Rachel K. Scott, Robert R. Bies, Sara K. Quinney, Dagan O. Lonsdale, Emma Forton Magavern, Catriona Waitt, Anita Banerjee   +14 more
wiley   +1 more source

Systemic Treatment of Psoriasis: Current Evidence on Efficacy and Safety

The Journal of Dermatology, EarlyView.
ABSTRACT Systemic treatments for moderate‐to‐severe plaque psoriasis have been advanced from broad immunosuppressants up to agents more selectively targeting cytokines, cytokine receptors, or intracellular signaling. The current systemic treatments mainly consist of conventional systemic agents, biologics targeting tumor necrosis factor (TNF)‐α ...
Teppei Hagino, Naoko Kanda
wiley   +1 more source

Analysis of Global Drug Development Pathways and Postmarketing Safety in Japan: Local Studies May Reduce Drug‐Related Deaths

Clinical and Translational Science, 2019
Recent International Conference on Harmonization (ICH) guidelines provide pharmaceutical companies with regulatory justifications to pursue various global drug‐development pathways, in some of which “local” dose‐ranging and/or pivotal phase III studies ...
Tomoko Kawamura Okubo, Shunsuke Ono
doaj   +1 more source

The implementation of rifapentine and isoniazid (3HP) in two remote Arctic communities with a predominantly Inuit population, the Taima TB 3HP study

International Journal of Circumpolar Health, 2020
Background: The incidence of TB among Inuit is the highest in Canada. A significantly shorter latent TB infection (LTBI) treatment with rifapentine and isoniazid once weekly for 12 weeks (3HP) is now available in limited settings in Canada.
G. G. Alvarez, D. Van Dyk, R. Mallick, S. Lesperance, P. Demaio, S. Finn, S. Edmunds Potvin, M. Patterson, C. Pease, K. Amaratunga, C. Hui, D.W. Cameron, S. Mulpuru, S.D. Aaron, F. Momoli, A. Zwerling   +15 more
doaj   +1 more source

Postmarketing Studies: Benefits and Risks

Value in Health, 1999
To consider the benefits and risks of large postmarketing outcomes studies, as demonstrated by studies of the statin drugs.Literature review.The risks were that the statin studies had a strong coat-tail effect. Each new study was beneficial to all statins as well as the one studied.
Garfield, Frances B., Caro, J. Jaime
openaire   +2 more sources