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Aspirin / chlorpheniramine / dextromethorphan Pregnancy and Breastfeeding Warnings

Brand names: Alka-Seltzer Plus Flu Formula (old formulation)

Aspirin / chlorpheniramine / dextromethorphan Pregnancy Warnings

Aspirin has not been formally assigned to pregnancy category by the FDA. However, aspirin is considered to be in pregnancy category D by the FDA if full dose aspirin is taken in the third trimester. Use of nonsteroidal anti-inflammatory drugs during the third trimester of pregnancy should be avoided due to effects on the fetal cardiovascular system (closure of the ductus arteriosus). Aspirin use in pregnancy has been associated with alterations in both maternal and fetal hemostasis. In addition, high doses have been associated with increased perinatal mortality, intrauterine growth retardation, and teratogenic effects. During the first two trimesters of pregnancy, aspirin should only be given during pregnancy when clearly needed and when benefit outweighs risk. In 1990, the FDA issued a warning that it is especially important not to use aspirin during the last trimester of pregnancy unless specifically directed to do so by a physician because it may cause problems in the unborn child or complications during delivery.

Chlorpheniramine has been assigned to pregnancy category B by the FDA. Animal studies have not been reported. There are no controlled data in human pregnancy.

Dextromethorphan has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of teratogenicity. There are no controlled data in human pregnancy.

Aspirin/chlorpheniramine/dextromethorphan is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

See references

Aspirin / chlorpheniramine / dextromethorphan Breastfeeding Warnings

Aspirin is excreted into human milk in small amounts. Peak milk salicylate levels have been reported at nine hours after maternal dosing (and measured at 1.1 mg/dL). Use of large doses of aspirin can result in rashes, platelet abnormalities, and bleeding in nursing infants. Because of a single case report of metabolic acidosis, the American Academy of Pediatrics characterizes aspirin as a drug that has been "associated with significant effects on some nursing infants and should be given to nursing mothers with caution.

There are no data on the excretion of chlorpheniramine into human milk.

There are no data on the excretion of dextromethorphan into human milk.

The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Based on the low molecular weight of dextromethorphan some passage into breast milk probably occurs. However, maternal use of dextromethorphan products that do not contain alcohol are probably safe to use during breast-feeding.

See references

References for pregnancy information

  1. Nelson MA, Forfar JO. Associations between drugs administered during pregnancy and congenital abnormalities of the fetus. Br Med J. 1971;1:523-7.
  2. Schoenfeld A, Bar Y, Merlob P, Ovadia Y. NSAIDs: maternal and fetal considerations. Am J Reprod Immunol. 1992;28:141-7.
  3. Heinonen O, Shapiro S; Kaufman DW ed., Slone D. Birth Defects and Drugs in Pregnancy. Littleton, MA: Publishing Sciences Group, Inc. 1977;297.
  4. Product Information. Chlor-Trimeton (chlorpheniramine). Schering-Plough. PROD.
  5. Parazzini F, Bortolus R, Chatenoud L, Restelli S, Benedetto C. Follow-up of children in the italian study of aspirin in pregnancy. Lancet. 1994;343:1235.
  6. Karlowicz MG, White LE. Severe intracranial hemorrhage in a term neonate associated with maternal acetylsalicylic acid ingestion. Clin Pediatr (Phila). 1993;32:740-3.
  7. Clasp: a randomised trial lf low-dose aspirin for the prevention and treatment of pre-eclampsia among 9364 pregnant women. Lancet. 1994;343:619-29.
  8. Product Information. Benylin DM (dextromethorphan). Warner Lambert Consumer Healthcare. 2001;PROD.
  9. Andaloro VJ, Monaghan DT, Rosenquist TH. Dextromethorphan and other N-methyl-D-aspartate receptor antagonists are teratogenic in the avian embryo model. Pediatr Res. 1998;43:1-7.
  10. Briggs GG, Freeman RK, Yaffe SJ. Drugs in Pregnancy and Lactation. Baltimore, MD: Williams & Wilkins. 1998.
  11. Product Information. Bayer Aspirin (acetylsalicylsyra). Bayer. PROD.
  12. Einarson A, Lyszkiewicz D, Koren G. The safety of dextromethorphan in pregnancy - Results of a controlled study. Chest. 2001;119:466-9.
  13. Debus O, Kurlemann G, Gehrmann J, Krasemann T. Dextromethorphan in pregnancy. Chest. 2001;120:1038-40.
  14. Subtil D, Deruelle P, Trillot N, Jude B. Preclinical phase of polycythemia vera in pregnancy. Obstet Gynecol. 2001;98(5 Pt 2):945-7.
  15. Kozer E, Nikfar S, Costei A, Boskovic R, Nulman I, Koren G. Aspirin consumption during the first trimester of pregnancy and congenital anomalies: A meta-analysis. Am J Obstet Gynecol. 2002;187:1623-30.
  16. Leonhardt A, Bernert S, Watzer B, Schmitz-Ziegler G, Seyberth HW. Low-dose aspirin in pregnancy: maternal and neonatal aspirin concentrations and neonatal prostanoid formation. Pediatrics. 2003;111:e77-81.
  17. Li DK, Liu L, Odouli R. Exposure to non-steroidal anti-inflammatory drugs during pregnancy and risk of miscarriage: population based cohort study. BMJ. 2003;327:368.

References for breastfeeding information

  1. Erickson SH, Oppenheim GL. Aspirin in breast milk. J Fam Pract. 1979;8:189-90.
  2. Product Information. Chlor-Trimeton (chlorpheniramine). Schering-Plough. PROD.
  3. Committee on Drugs, 1992 to 1993. The transfer of drugs and other chemicals into human milk. Pediatrics. 1994;93:137-50.
  4. Product Information. Benylin DM (dextromethorphan). Warner Lambert Consumer Healthcare. 2001;PROD.
  5. Briggs GG, Freeman RK, Yaffe SJ. Drugs in Pregnancy and Lactation. Baltimore, MD: Williams & Wilkins. 1998.
  6. Product Information. Bayer Aspirin (acetylsalicylsyra). Bayer. PROD.

Further information

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