date, no therapeutic drug concentrations of aripiprazole have been established. Although quantitative data are limited with respect to the drug’s bio-availability, Yokoi et al. reported that administration for 14 days in 15 males, in doses of 0.5, 1, 2, 10, and 30 mg/day, resulted in dose-dependent receptor occupancy between 40% and 95%. The investigators found that it was possible to obtain an adequate occupancy and that the data might be […]
Although minimal side effects from have been reported, complete clinical data have not yet been established. In a 52-week study reported by Bristol-Myers Squibb, 1,294 patients with schizophrenia were evaluated to establish efficacy, safety, and tolerabil-ity. Patients taking aripiprazole experienced significantly fewer extrapyramidal symptoms than patients taking haloperi-dol. The most commonly reported adverse drug events associated with arip-iprazole in this study were insomnia, psychosis, anxiety, and akathisia. The incidence of […]
Although early antipsychotic agents, such as (GlaxoSmithKline) and haloperidol (Haldol®, Ortho-McNeill) showed great promise initially, their limitations became evident when extrapyramidal side effects were associated with their use. Subsequently, the novel atypical antipsychotics, such as (Novartis), risperidone drug ( Risperdal canadian , Janssen), canadian olanzapine (Eli Lilly), quetiapine fuma-rate ( Seroquel canadian , AstraZeneca), Pfizer), demonstrated fewer extrapyramidal side effects, thus providing an option […]
PL. 107-109 of the BPCA reauthorizes the pediatric studies provision of the 1997 Modernization Act to improve the safety and efficacy of pharmaceuticals for children. It continues to encourage pharmaceutical companies to conduct studies of on-patent drugs that are used in pediatric populations (but that are […]
After several years of clinical studies, important label changes have had an impact on the use of these drugs in children (Table 1).
2002 and 2003
In January 2003, the Secretary of DHHS revealed that 12 commonly prescribed drugs would now require clinical testing for use in children. The governmental agencies (DHHS and FDA) have planned to support the testing of the drugs starting this year. Pediatric drug testing is […]
The FDA, working under the aegis of the Congress, began to persuade pharmaceutical companies to provide pediatric labeling information on drugs if such data were available. Initially, a 1979 FDA regulation required full clinical trials in pediatric populations as the basis for drug labeling for chil-dren, but progress in achieving this goal was made very slowly. The 1979 regulation permitted pediatric claims only if there had been adequate and […]
PROBLEMS OF DRUG TESTING IN CHILDREN
Children obviously need medicines, medical health professionals agree, but they are considered “therapeutic orphans” when it comes to drug development. Most drugs are studied, approved, and labeled for use in adults. To use one of these approved […]
Blog invites submissions of review articles, reports on clinical techniques, case reports, conference summaries, and articles of opinion pertinent to the control of pain and anxiety in dentistry.