Boxed Warning Added to Promethazine Labeling for Pediatric Use

New England Journal of Medicine (Impact Factor: 54.42). 07/2005; 352(25):2653. DOI: 10.1056/NEJM200506233522522
Source: PubMed
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    ABSTRACT: This chapter reviews published studies in the field of pediatric therapeutics between July 1998 and July 2000. The most important area discussed in the first part of the chapter concerns the significant advances made in the labeling of drugs for children in the United States. Dr Harry Shirkey coined the term "therapeutic orphan" in 1968 to describe the state of children who were not being considered in either drug development or in drug clinical trials. This explains why about 80% of drugs listed in each edition of the Physicians' Desk Reference do not have labeling for the pediatric age group, especially children younger than 12 years. The recent legislative, regulatory, and pharmaceutical company activities to change this situation are summarized. These changes are current and promise to make significant contributions to the availability of drugs with adequate pediatric indications to the practicing physician. Another important change in recent years has been the appreciation of the importance of placebo-controlled clinical trials for psychotropic medications in children. Trials with one of the selective serotonin reuptake inhibitors, as well as further studies involving the appropriate dosing and preparation of stimulant drugs for attention-deficit/hyperactivity disorder (ADHD), are also discussed. Several new areas that promise significant knowledge in therapeutics are in the treatment of osteoporosis (a neglected condition in pediatrics), arthritis (a condition for which drugs are used to treat the disease rather than the symptoms), and acquisition of data concerning transplacental transfer of human immunodeficiency virus (HIV) and use of multiple anti-HIV drugs for treatment of this virus in the pediatric population.
    Advances in Pediatrics 02/2001; 48:439-64.
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    ABSTRACT: To describe the use of psychotropic drugs in children aged 0-5 years, in the Aquitaine region of South-west France and identify associated socio-demographic, familial and medical factors. Data used in this study come from the regional drug claims database of the National Health Insurance System of Aquitaine and from postal self-questionnaires sent to parents and prescribing physicians. In Aquitaine, psychotropic drugs were redeemed at least once in 2002 for 3.2% of young children. Hydroxyzine, niaprazide or diazepam were claimed at least once by 2.7% of children registered in the database. Prescribers were mostly general practitioners (76.7%) and pediatricians (20.1%). Psychotropic claims were more frequent in children having the highest number of medical consultations in 2002 (more than 7: odds ratio (OR) = 1.5 [95% confidence interval (CI): 1.3-1.7]) or of drug deliveries (7-15 deliveries: OR = 1.8 [95%CI: 1.6-2.1]; more than 15 deliveries: OR = 3.2 [95%CI: 2.7-3.9]). Psychotropic claim frequency increased with age. No association of psychotropic use with parental psychotropic use, socio-professional category and familial situation was found. Psychotropic delivery prevalence in Aquitaine in young children was below 5% in 2002. It notably concerned drugs of which the use is not devoid of toxicity because of anticholinergic properties.
    Pharmacoepidemiology and Drug Safety 07/2006; 15(7):504-9. DOI:10.1002/pds.1224 · 3.17 Impact Factor
  • Pediatric Asthma Allergy &amp Immunology 09/2006; 19(3):185-189. DOI:10.1089/pai.2006.19.185
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