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Diphenhydramine / ibuprofen Pregnancy and Breastfeeding Warnings

Diphenhydramine / ibuprofen is also known as: Advil PM, Ibuprofen PM, Motrin PM

Diphenhydramine / ibuprofen Pregnancy Warnings

Diphenhydramine-ibuprofen has not been formally assigned to a pregnancy category by the FDA. Diphenhydramine has been assigned to pregnancy category B by the FDA. Animal studies have failed to reveal teratogenicity. The Collaborative Perinatal Project reported 595 first-trimester exposures and 2,948 exposures anytime during pregnancy. No relationship was found to large categories of malformations. Possible associations with individual malformation were found. One study reported a statistical relationship between diphenhydramine use in the first trimester and cleft palate. One case of withdrawal in an infant whose mother ingested 150 mg per day of diphenhydramine has been reported. This infant developed tremor on the fifth day of life which was treated with phenobarbital. Ibuprofen has been assigned to pregnancy category B by the FDA. Animal studies failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy. While there are no literature reports linking the use of ibuprofen in pregnancy with birth defects, use late in pregnancy may cause premature closure of the ductus arteriosus and prolong labor and delivery. Diphenhydramine-ibuprofen should only be given during pregnancy when benefit outweighs risk. Ibuprofen should be avoided near term (last three months of pregnancy).

One manufacturer of ibuprofen has reported on 50 in utero exposures to ibuprofen. Seven cases were reported retrospectively and included one-third trimester fetal death of unknown cause, one spontaneous abortion without evidence of abnormalities, anencephaly (N=1), petit mal seizures progressing to grand mal seizures (N=1), cerebral palsy (N=1), microphthalmia, nasal cleft, and mildly rotated palate (N=1), and tooth staining (N=1). Of the 43 prospective cases, 23 were followed to a normal delivery. Of the remaining cases, one ended in a stillbirth without abnormalities, one ended in a spontaneous abortion without abnormalities, and the remaining were lost to follow-up.

See references

Diphenhydramine / ibuprofen Breastfeeding Warnings

Diphenhydramine is excreted into human milk. Diphenhydramine may also inhibit lactation. Ibuprofen has not been detected in human milk. Ibuprofen is considered compatible with breast-feeding by the American Academy of Pediatrics. 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.

See references

References for pregnancy information

  1. Saxen I "Letter: Cleft palate and maternal diphenhydramine intake." Lancet 1 (1974): 407-8
  2. "Product Information. Motrin (ibuprofen)." Pharmacia and Upjohn, Kalamazoo, MI.
  3. Koren G, Pastuszak A, Ito S "Drugs in pregnancy." N Engl J Med 338 (1998): 1128-37
  4. Leathem AM "Safety and efficacy of antiemetics used to treat nausea and vomiting in pregnancy." Clin Pharm 5 (1986): 660-8
  5. Zierler S, Purohit D "Prenatal antihistamine exposure and retrolental fibroplasia." Am J Epidemiol 123 (1986): 192-6
  6. Heinonen O, Slone D, Shapiro S; Kaufman DW ed. "Birth Defects and Drugs in Pregnancy." Littleton, MA: Publishing Sciences Group, Inc. (1977): 297
  7. Brost BC, Scardo JA, Newman RB "Diphenhydramine overdose during pregnancy: lessons from the past." Am J Obstet Gynecol 175 (1996): 1376-7
  8. Parkin DE "Probable Benadryl withdrawal manifestations in a newborn infant." J Pediatr 85 (1974): 580
  9. Barry WS, Meinzinger MM, Howse CR "Ibuprofen overdose and exposure in Utero: results from a postmarketing voluntary reporting system." Am J Med 77 (1984): 35-9

References for breastfeeding information

  1. Weibert RT, Townsend RJ, Kaiser DG, Naylor AJ "Lack of ibuprofen secretion into human milk." Clin Pharm 1 (1982): 457-8
  2. "Product Information. Motrin (ibuprofen)." Pharmacia and Upjohn, Kalamazoo, MI.
  3. Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50
  4. Townsend RJ, Benedetti TJ, Erickson SH, Cengiz C, Gillespie Wr, Gschwend J, Albert KS "Excretion of ibuprofen into breast milk." Am J Obstet Gynecol 149 (1984): 184-6
  5. Ring ME, Corrigan JJ, Fenster PE "Effects of oral diltiazem on platelet function: alone and in combination with "low dose" aspirin." Thromb Res 44 (1986): 391-400

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