sedative/hypnotic (tranquilizer)

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Adverse effects

  • increased mortality risk in patients taking sedative/ hypnotics 30 times in the past month
  • increased mortality (2-fold increase in 8 year mortality)[3]
  • repeated use of general anesthetics & sedatives, or use for > 3 hours, in children < 3 years of age & in women in the 3rd trimester of pregnancy could adversely affect child brain development[4]*
  • prolonged exposure to sedative in children < 3 years of age may adversely affect brain development[5]

* ACOG takes issue with warning[4]

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References

  1. UCLA Intensive Course in Geriatric Medicine & Board Review, Marina Del Ray, CA, Sept 12-15, 2001
  2. FDA MedWatch http://www.fda.gov/medwatch/safety/2007/safety07.htm#Sedative
  3. 3.0 3.1 Weich S et al Effect of anxiolytic and hypnotic drug prescriptions on mortality hazards: retrospective cohort study. BMJ 2014;348:g1996 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/24647164 <Internet> http://www.bmj.com/content/348/bmj.g1996
  4. 4.0 4.1 4.2 FDA Safety Alert. Dec 14, 2016 General Anesthetic and Sedation Drugs: Drug Safety Communication
    New Warnings for Young Children and Pregnant Women. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm533195.htm
    FDA Drug Safety Communication: Dec 14, 2016 FDA review results in new warnings about using general anesthetics and sedation drugs in young children and pregnant women. http://www.fda.gov/Drugs/DrugSafety/ucm532356.htm
    American College of Obstetricians & Gynecologists. Dec 21, 2016 Practice Advisory: FDA Warnings Regarding Use of General Anesthetics and Sedation Drugs in Young Children and Pregnant Women. http://www.acog.org/About-ACOG/News-Room/Practice-Advisories/FDA-Warnings-Regarding-Use-of-General-Anesthetics-and-Sedation-Drugs
  5. 5.0 5.1 FDA Safety Alert. April 27, 2017 General Anesthetic and Sedation Drugs: Drug Safety Communication
    FDA Approves Label Changes for Use in Young Children. https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm555631.htm