Poisoning by Drugs, Medicaments and Biological Substances Codexery

Gray baby syndrome

Rare, fatal neonatal toxicity from chloramphenicol accumulation.

Gray baby syndrome is a rare but serious side effect in newborns from accumulated chloramphenicol.[1] The condition can be fatal if not diagnosed early.[1][2] It is dose-related and typically appears 2 to 9 days after starting the medication.[3]

Quick Facts

Serum warning level
>50 μg/mL
Therapeutic peak level
10-20 μg/mL
Onset range
2 to 9 days after initiation of medication
Toxic daily dose threshold
greater than 200 milligrams
Neonate age contraindication
less than one week old (especially preterm)

Facts from the source article.

Key facts and history

In 1958, premature newborns given chloramphenicol to prevent infections showed a higher mortality rate than untreated infants.[4] The syndrome results from insufficient glucuronidation in the baby's liver, causing toxic chloramphenicol metabolites to accumulate.[5] High chloramphenicol levels block electron transport in the liver, myocardium, and skeletal muscles.[2] This blockade can cause cell damage because electron transport is essential for cellular respiration.[2]

The drug also weakens bilirubin-albumin binding, potentially leading to brain damage or kernicterus.[2] Common signs include ashen gray skin, vomiting, hypotension, cyanosis, hypothermia, and cardiovascular collapse.[2] The syndrome does not result from maternal use during pregnancy or breastfeeding.[6] In newborn infants, the UDP-glucuronyl transferase enzyme system is not fully developed, which prevents them from metabolizing the required amount of chloramphenicol for excretion.[5]

The buildup of the drug is also worsened by the kidneys' inability to adequately excrete the unconjugated form.[5]

What the cited sources add

The MSD Manual states that gray baby syndrome involves hypothermia, cyanosis, flaccidity, and circulatory collapse and is often fatal.[7] To avoid the syndrome, clinicians should not give infants ≤ 1 month of age more than 25 mg/kg/day initially.[7][8] The MSD Manual also notes that chloramphenicol has no teratogenic effects.[7] Reversible dose-related bone marrow depression is an early sign of toxicity.[7][9]

References

  1. Wikipedia, "Gray baby syndrome" (CC BY-SA 4.0), which cites: "Drug toxicity in the neonate", Biology of the Neonate, 2004, p. 218–21 (original not read by us) en.wikipedia.org
  2. Wikipedia, "Gray baby syndrome" (CC BY-SA 4.0), which cites: "StatPearls", StatPearls Publishing, 2021 (original not read by us) en.wikipedia.org
  3. Wikipedia, "Gray baby syndrome" (CC BY-SA 4.0), which cites: "Clindamycin, metronidazole, and chloramphenicol", Mayo Clinic Proceedings, 1999, p. 825–33; "Clindamycin, metronidazole, and chloramphenicol", Mayo Clinic Proceedings, 1999, p. 825–33; "Laboratory guidelines for monitoring of antimicrobial drugs.", Clinical Chemistry, 1998, p. 1129–40 (original not read by us) en.wikipedia.org
  4. Wikipedia, "Gray baby syndrome" (CC BY-SA 4.0), which cites: "Chloramphenicol: new perspectives on an old drug", Drug Intelligence & Clinical Pharmacy, April 1982, p. 295–300; "Chloramphenicol", LiverTox: Clinical and Research Information on Drug-Induced Liver Injury, 2012; "Old drug, new wrapping – A possible comeback for chloramphenicol?", International Journal of Pharmaceutics, June 2017, p. 538–546; "Pharmacovigilance: An Overview", Clinical Therapeutics, December 2018, p. 1991–2004 (original not read by us) en.wikipedia.org
  5. Wikipedia, "Gray baby syndrome" (CC BY-SA 4.0), which cites: "Goodman & Gilman's The Pharmacological Basis of Therapeutics", McGraw-Hill, 2005, p. 1173–1202; "StatPearls", StatPearls Publishing, 2021 (we also read that source) en.wikipedia.org
  6. Wikipedia, "Gray baby syndrome" (CC BY-SA 4.0), which cites: "Drugs and Lactation Database (LactMed)", National Library of Medicine (US), 2006; "WHO model formulary for children 2010", World Health Organization, 2010, p. 99–101; "Safety of Antimicrobials During Pregnancy: A Systematic Review of Antimicrobials Considered for Treatment and Postexposure Prophylaxis of Plague", Clinical Infectious Diseases, 2020, p. S37–S50 (original not read by us) en.wikipedia.org
  7. Werth, "Chloramphenicol", MSD Manual Professional Edition, 2020. facts only, no text reused. msdmanuals.com
  8. Wikipedia, "Gray baby syndrome" (CC BY-SA 4.0), which cites: "Chloramphenicol: what we have learned in the last decade", Southern Medical Journal, 1986, p. 1129–34; "Chloramphenicol toxicity in neonates: its incidence and prevention", British Medical Journal, 1983, p. 1424–7; "[Need for the determination of chloramphenicol levels in the treatment of bacterial-purulent meningitis with chloramphenicol succinate in infants and small children]", Monatsschrift Kinderheilkunde, 1985, p. 209–13; "Key Potentially Inappropriate Drugs in Pediatrics: The KIDs List", The Journal of Pediatric Pharmacology en.wikipedia.org
  9. Wikipedia, "Gray baby syndrome" (CC BY-SA 4.0), which cites: "Meyler's Side Effects of Drugs: The International Encyclopedia of Adverse Drug Reactions and Interactions", 2016, p. 229–236 (we also read that source) en.wikipedia.org

Each numbered sentence above was checked against the source it cites before publication. Sentences citing Wikipedia adapt text from the English Wikipedia article Gray baby syndrome (contributors), used under CC BY-SA 4.0; this entry is available under the same licence. Other sources were used for facts only; no text or images are copied from them.

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