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Drug Labels (drug + label)
Selected AbstractsPharmacodynamic differentiation of lorazepam sleepiness and dizziness using an ordered categorical measureJOURNAL OF PHARMACEUTICAL SCIENCES, Issue 8 2010Mohamed A. Kamal Abstract Categorical measures of lorazepam sleepiness and dizziness were modeled to identify differences in pharmacodynamic (PD) parameters between these adverse events (AEs). Differences in data-derived PD parameters were compared with relative incidence rates in the drug label (15.7% and 6.9%, respectively). Healthy volunteers (n,=,20) received single oral doses of 2,mg lorazepam or placebo in a randomized, double-blind, cross-over fashion. A seven-point categorical scale measuring the intensity of AEs was serially administered over 24,h. The maximum score (MaxS), and area under the effect curve (AUEC) were determined by noncompartmental methods and compared using a paired t -test. Individual scores were modeled using a logistic function implemented in NONMEM. AUEC and MaxS for sleepiness were significantly higher than dizziness (20.35 vs. 9.76, p,<,0.01) and (2.35 vs. 1.45, p,<,0.01). Model slope estimates were similar for sleepiness and dizziness (0.21,logits,×,mL/ng vs. 0.19,logits,×,mL/ng), but baseline logits were significantly higher for sleepiness (,2.81 vs. ,4.34,logits). Data-derived PD parameters were in concordance with label incidence rates. The higher intensity of sleepiness may be directly related to baseline (no drug present) while the increase in intensity as a result of drug was relatively similar for both AEs. © 2010 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 99:3628,3641, 2010 [source] FDA report: Ferumoxytol for intravenous iron therapy in adult patients with chronic kidney disease,,§AMERICAN JOURNAL OF HEMATOLOGY, Issue 5 2010Min Lu On June 30, 2009, the United States Food and Drug Administration (FDA) approved ferumoxytol (FerahemeÔ injection, AMAG Pharmaceuticals), an iron-containing product for intravenous (IV) administration, for the treatment of iron deficiency anemia in adult patients with chronic kidney disease (CKD). The safety and efficacy of ferumoxytol were assessed in three randomized, open-label, controlled clinical trials. Two trials evaluated patients with nondialysis dependent CKD and a third trial assessed patients undergoing hemodialysis. Randomization was either to ferumoxytol or oral iron. Ferumoxytol was administered as two 510 mg IV injections, separated by 3,8 days. Oral iron, Ferro-Sequels®, was administered at a dose of 100 mg twice daily for 21 days. In all three clinical trials, ferumoxytol administration increased the mean blood hemoglobin (Hgb) concentrations by ,1.0 g/dL over the 35 day period, a mean increase that was greater than what was observed in patients receiving oral iron. Patients receiving ferumoxytol also had increases in blood transferrin saturation (TSAT) and ferritin values. For the proposed ferumoxytol dosing regimen, 4.9% of patients had serum ferritin ,800 ng/mL and TSAT ,50% post-treatment. The most important ferumoxytol safety concerns were hypersensitivity reactions and/or hypotension. Anaphylaxis or anaphylactoid reactions were reported in 0.2% of subjects, and other adverse reactions potentially associated with hypersensitivity (e.g., pruritus, rash, urticaria, or wheezing) were reported in 3.7%. Hypotension was observed in 1.9%, including three patients with serious hypotensive reactions. Ferumoxytol administration may transiently affect the diagnostic ability of magnetic resonance imaging and the drug label provides further information regarding this effect. Am. J. Hematol. 2010. Published 2010 Wiley-Liss, Inc. [source] Retailers' tagging practices: a potential liability?PACKAGING TECHNOLOGY AND SCIENCE, Issue 1 2004Laura Bix Abstract This study investigates the coverage of federally mandated information on over-the-counter (OTC) drug labels by electronic article surveillance (EAS) tags applied to the exterior of cartons. Using adult-strength analgesics containing acetaminophen as a case study, researchers investigated the issue in Houston, Texas (24 stores) and Lansing, Michigan (33 stores). The information obscured by EAS tags was identified and classified for a total of 849 packages using a standardized data collection instrument. The results indicated that 293 packages examined, or 34.5%, had information mandated by the US Food and Drug Administration (US FDA) fully or partially obscured by the EAS tags. Retailers and manufacturers should be aware of such practices to reduce potential liability. Recommendations for improving EAS tag usage on OTC products are presented. Copyright © 2004 John Wiley & Sons, Ltd. [source] Is x-height a better indicator of legibility than type size for drug labels?PACKAGING TECHNOLOGY AND SCIENCE, Issue 5 2003Laura Bix Abstract In 1999 the US Food and Drug Administration published a regulation in an attempt to ensure the legibility of OTC drugs, specifying, among other things, a minimum type size of 6 points. This is problematic because different typefaces of the same size vary widely in type heights and, presumably, legibility. We hypothesized that specifying a minimum x-height, the height of the lowercase x, would produce more consistent legibility than the minimum type size specified within the regulation. Twenty-six subjects viewed two groups of typefaces using the Lockhart Legibility Instrument to quantify legibility. The first group contained typefaces that were all 6 points, but, by nature of their design, varied greatly in their x-heights. The second group was made from the same set of typefaces, but these were manipulated so that their x-heights were equal to the average x-height of group 1. A likelihood ratio test indicated that the group that varied in x-height, group 1, produced significantly more variable results than the group with equal x-heights, group 2. This indicates that specifying a minimum type size may not be the best approach for producing consistent legibility. Copyright © 2003 John Wiley & Sons, Ltd. [source] International Colour Coding for syringe drug labels: a surveyANAESTHESIA, Issue 10 2004R. Baba No abstract is available for this article. [source] Cheese, drug labels and anaesthetic room errorANAESTHESIA, Issue 2 2002C. P. Leng No abstract is available for this article. [source] Pivotal studies of orphan drugs approved for neurological diseases,ANNALS OF NEUROLOGY, Issue 2 2009Jun Mitsumoto MPH Objective To identify design elements of clinical trials leading to US Food and Drug Administration approval of drugs for neurological diseases with and without orphan indications. Methods We used publicly available information to identify approvals for drugs for neurological diseases with an orphan indication (n = 19) and compared them with recent approvals for drugs for neurological diseases without an orphan indication (n = 20). We identified "pivotal trials" from drug labels and drug approval packages, and assessed them on four elements of clinical trial design: control, blinding, randomization, and size. Results All drugs for neurological diseases (100%) approved without an orphan indication included at least two randomized, double-blind, placebo-controlled trials. In comparison, 32% of drugs with an orphan indication had at least two such trials (p < 0.001) and 74% had at least one (p = 0.02). Thirty-three pivotal trials were conducted for the 19 drugs approved with an orphan indication. Of the 33 trials, 11 (33%) did not use a placebo control, 9 (27%) were not double blind, and 4 (12%) were not randomized. Drugs approved without an orphan indication had more pivotal trials per drug (3.8 vs 1.7 trials; p < 0.001) and a larger mean trial size (506 vs 164 trial participants; p < 0.001). Interpretation The US Food and Drug Administration has approved orphan drugs for neurological diseases without randomized, doubled-blind, placebo-controlled pivotal trials. As orphan drug development grows, demand will likely increase for alternative designs for conducting adequate and well-controlled studies to demonstrate drug efficacy. Ann Neurol 2009;66:184,190 [source] | ||||||||||