Boxed Warning Added to Promethazine Labeling for Pediatric Use

New England Journal of Medicine (Impact Factor: 55.87). 07/2005; 352(25):2653. DOI: 10.1056/NEJM200506233522522
Source: PubMed
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    • "In the United States, reports of serious and often life-threatening adverse events of promethazine in children led to a "boxed warning" being added in 2004 to the labeling of promethazine. The warning included a contraindication for use in children younger than 2 years and a strengthened warning with regard to use in children 2 years of age or older[24]. In February 2009, the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom[25] advised that cough and cold remedies containing certain ingredients, including first-generation H1-antihistamines, should no longer be used in children younger than 6 years because the balance of benefit and risks has not been shown to be favorable. "
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    ABSTRACT: This article reviews the molecular biology of the interaction of histamine with its H1-receptor and describes the concept that H1-antihistamines are not receptor antagonists but are inverse agonists i.e. they produce the opposite effect on the receptor to histamine. It then discourages the use of first-generation H1-antihistamines in clinical practice today for two main reasons. First, they are less effective than second generation H1-antihistamines. Second, they have unwanted side effects, particularly central nervous system and anti-cholinergic effects, and have the potential for causing severe toxic reactions which are not shared by second-generation H1-antihistamines. There are many efficacious and safe second-generation H1-antihistamines on the market for the treatment of allergic disease. Of the three drugs highlighted in this review, levocetirizine and fexofenadine are the most efficacious in humans in vivo. However, levocetirizine may cause somnolence in susceptible individuals while fexofenadine has a relatively short duration of action requiring twice daily administration for full all round daily protection. While desloratadine is less efficacious, it has the advantages of rarely causing somnolence and having a long duration of action. Lastly, all H1-antihistamines have anti-inflammatory effects but it requires regular daily dosing rather than dosing ‘on-demand’ for this effect to be clinically demonstrable.
    World Allergy Organization Journal 02/2011; 4(3):S22-S27. DOI:10.1097/WOX.0b013e3181f385d9
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    • "Since its approval in 1951, serious and often life-threatening adverse events; including respiratory depression; over sedation; agitation; hallucinations; seizures; and dystonic reactions have been reported with promethazine use in children.95,96 As of 2005, there were 38 cases of respiratory depression, apnea, or cardiac arrest reported to the Food and Drug Administration (FDA).97 Twenty two of them were in children aged 1.5 months to 2 years of age, 7 of which died. "
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    ABSTRACT: Acute gastroenteritis is a very common disease. It causes significant mortality in developing countries and significant economic burden to developed countries. Viruses are responsible for approximately 70% of episodes of acute gastroenteritis in children and rotavirus is one of the best studied of these viruses. Oral rehydration therapy is as effective as intravenous therapy in treating mild to moderate dehydration in acute gastroenteritis and is strongly recommended as the first line therapy. However, the oral rehydration solution is described as an underused simple solution. Vomiting is one of the main reasons to explain the underuse of oral rehydration therapy. Antiemetics are not routinely recommended in treating acute gastroenteritis, though they are still commonly prescribed. Ondansetron is one of the best studied antiemetics and its role in enhancing the compliance of oral rehydration therapy and decreasing the rate of hospitalization has been proved recently. The guidelines regarding the recommendation on antiemetics have been changed according to the evidence of these recent studies.
    Clinical and Experimental Gastroenterology 07/2010; 3(1):97-112.
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    • "Four (19%) of 21 patients who were on promethazine therapy were children aged less than two years. The use of promethazine in infants has been restricted due to safety concerns (18). Moreover, four (26.7%) of 15 patients who were receiving prochlorperazine were adults who received prochlorperazine intramuscularly. "
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    ABSTRACT: This nationwide study was conducted to assess the extent of adherence of primary-care physicians to the World Health Organization (WHO)-recommended guidelines on the use of oral rehydration therapy (ORT), antimicrobials, and prescribing of other drugs used in treating symptoms of acute diarrhoea in Bahrain. A questionnaire-based, cross-sectional survey was carried out in primary-care health centres. During a six-week survey period (15 August-30 September 2003), 328 (25.2%) completed questionnaires were returned from 17 of 20 health centres. In a sample of 300 patients, oral rehydration salts (ORS) solution was prescribed to 89.3% (n=268) patients; 12.3% received ORS alone, whereas 77% received ORS in combination with symptomatic drugs. Antimicrobials were prescribed to 2% of the patients. In 11.4% of the cases, rehydration fluids and other drugs were given parenterally The mean number of drugs was 2.2+0.87 per prescription. In approximately one-third of the patients, three or more drugs were used. Primary-care physicians almost always adhered to the WHO guidelines with respect to ORT and antimicrobials. However, in several instances, ORT was prescribed along with polypharmacy, including irrational use of drugs for symptomatic relief. Effective health policies are needed to reduce the unnecessary burden on the healthcare system.
    Journal of Health Population and Nutrition 07/2007; 25(2):205-11. · 1.04 Impact Factor
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