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Acetaminophen / pseudoephedrine Pregnancy and Breastfeeding Warnings

Acetaminophen / pseudoephedrine is also known as: Alka-Seltzer Cold and Sinus, Allerest No Drowsiness, Bayer Select Sinus Pain Formula, Benadryl Allergy Sinus Headache, Contac Sinus, Dristan Cold Non-Drowsy, Ephed Plus, Genapap Sinus, Ornex, Ornex Maximum Strength, Phenapap, Pseudoephedrine Sinus, Sinarest Sinus, Sine-Off Maximum Strength, Sinus Maximum Strength, Sinus Relief, Sinutab Maximum Strength, Sinutab Maximum Strength Non Drowsy, Sinutab Regular Strength, Sudogest Sinus Maximum Strength, Suphedrin Plus, Suphedrin Sinus, Tavist Sinus, Tylenol Sinus Maximum Strength

Acetaminophen / pseudoephedrine Pregnancy Warnings

Acetaminophen: Two cases of acetaminophen overdose in late pregnancy have been reported. In both cases neither the neonate nor the mother suffered hepatic toxicity. Investigations have revealed conflicting results with regards to the pharmacokinetic disposition of acetaminophen in pregnant women. One study has suggested that the oral clearance of acetaminophen is 58% higher and the elimination half-life is 28% lower in pregnant women compared to non-pregnant women. Another study has suggested that the elimination half-life is not different in patients who are pregnant. That study also suggested that the volume of distribution of acetaminophen may be higher in pregnant women. One study has suggested that acetaminophen in typical oral doses may result in a reduced production of prostacyclin in pregnant women. That study has also suggested that acetaminophen does not affect thromboxane production. Pseudoephedrine: A case-controlled surveillance study reported an elevated relative risk (3.2) associated with first-trimester pseudoephedrine use in 76 cases of gastroschisis. Relative risks for other drugs were 1.6 for salicylates, 1.7 for acetaminophen, 1.3 for ibuprofen, and 1.5 for phenylpropanolamine (not significant). The authors hypothesized vascular disruption was the etiology of gastroschisis. A second group of 416 infants with heterogeneous defects suspected to have a vascular etiology was studied. There was no increased risk associated with salicylates, ibuprofen, pseudoephedrine, phenylpropanolamine and other decongestants. These data require independent confirmation. In a review of 229,101 deliveries to Michigan Medicaid patients, 940 first-trimester exposures to pseudoephedrine and 1919 exposures anytime during pregnancy were recorded. A total of 37 birth defects were reported with first-trimester exposure (40 expected) and included (observed/expected) 3/9 cardiovascular defects, 2 oral clefts, and 3/2 polydactyly. These researchers reviewed nine cases of abdominal wall defects in the 1980-1983 Medicaid data compared to 3752 pseudoephedrine-exposed pregnancies, providing a relative risk of 1.8. Seven of the nine cases had been exposed to pseudoephedrine and of these only one case was a surgically treated abdominal wall defect. (written communication, Franz Rosa, MD, Food and Drug Administration, 1994 The Collaborative Perinatal Project monitored 50,282 mother-child pairs. Only 39 first-trimester exposures to pseudoephedrine were recorded, with one birth defect observed. For use anytime during pregnancy, 194 exposures were recorded with 3 birth defects observed (3.22 expected). The effect of pseudoephedrine on uterine and fetal blood flow was studied in 12 healthy pregnant women between 26 and 40 weeks gestation. Following a single 60 mg dose of pseudoephedrine, no significant effects was seen on fetal heart rate, uterine blood flow, or fetal aortic blood flow.

Acetaminophen has not been formally assigned to a pregnancy category. It is routinely used for short-term pain relief and as an antipyretic in all stages of pregnancy. Acetaminophen is believed to be safe in pregnancy when used intermittently for short durations. Acetaminophen should only be given during pregnancy when need has been clearly established. Pseudoephedrine has not been officially assigned to a pregnancy category. There are no controlled data in human pregnancy. Based on available data, pseudoephedrine is not thought to be teratogenic. Pseudoephedrine should only be used during pregnancy if benefit outweighs the risk to the fetus.

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Acetaminophen / pseudoephedrine Breastfeeding Warnings

Acetaminophen is excreted into human milk in small concentrations. One case report of an adverse effect (involving a rash) has been reported in a nursing infant. Acetaminophen is considered compatible with breast-feeding by the American Academy of Pediatrics. Pseudoephedrine is excreted into human milk. There are no reports of adverse effects in infants who were exposed to pseudoephedrine by breast milk. The American Academy of Pediatrics considers pseudoephedrine to be compatible with breast-feeding.

One small study has reported that following a 1000 mg dose of acetaminophen to nursing mothers, nursing infants receive less than 1.85% of the weight-adjusted maternal oral dose. Three mothers given pseudoephedrine demonstrated milk concentrations consistently higher than plasma concentrations. Maximum milk concentrations were reached at 1 to 1.5 hours after dosing. In one woman, the milk:plasma concentration ratio at 1,3, and 12 hours was 3.3, 3.9, and 2.6. The authors calculated that 100 mL of breast milk consumed over 24 hours would provide an infant with 0.25 to 0.33 mg of pseudoephedrine or 0.5% to 0.7% of the dose ingested by the mother.

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References for pregnancy information

  1. O'Brien WF, Krammer J, O'Leary TD, Mastrogiannis DS "The effect of acetaminophen on prostacyclin production in pregnant women." Am J Obstet Gynecol 168 (1993): 1164-9
  2. Levy G, Garrettson LK, Soda DM "Evidence of placental transfer of acetaminophen." Pediatrics 55 (1975): 895
  3. Galinsky RE, Levy G "Absorption and metabolism of acetaminophen shortly before parturition." Drug Intell Clin Pharm 18 (1984): 977-9
  4. Rayburn W, Shukla U, Stetson P, Piehl E "Acetaminophen pharmacokinetics: comparison between pregnant and nonpregnant women." Am J Obstet Gynecol 155 (1986): 1353-6
  5. Smith CV, Rayburn WF, Anderson JC, Duckworth AF, Appel LL "Effect of a single dose of oral pseudoephedrine on uterine and fetal Doppler blood flow." Obstet Gynecol 76 (1990): 803-6
  6. Miners JO, Robson RA, Birkett DJ "Paracetamol metabolism in pregnancy." Br J Clin Pharmacol 22 (1986): 359-62
  7. Rudolph AM "Effects of aspirin and acetaminophen in pregnancy and in the newborn." Arch Intern Med 141 (1981): 358-63
  8. Heinonen O, Slone D, Shapiro S; Kaufman DW ed. "Birth Defects and Drugs in Pregnancy." Littleton, MA: Publishing Sciences Group, Inc. (1977): 297
  9. Roberts I, Robinson MJ, Mughal MZ, Ratcliffe JG, Prescott LF "Paracetamol metabolites in the neonate following maternal overdose." Br J Clin Pharmacol 18 (1984): 201-6
  10. Byer AJ, Traylor TR, Semmer JR "Acetaminophen overdose in the third trimester of pregnancy." JAMA 247 (1982): 3114-5
  11. Werler MM, Mitchell AA, Shapiro S "First trimester maternal medication use in relation to gastroschisis." Teratology 45 (1992): 361-7

References for breastfeeding information

  1. Findlay JW, DeAngelis RL, Kearney MF, et al "Analgesic drugs in breast milk and plasma." Clin Pharmacol Ther 29 (1981): 625-33
  2. Findlay JW, Butz RF, Sailstad JM, Warren JT, Welch RM "Pseudoephedrine and triprolidine in plasma and breast milk of nursing mothers." Br J Clin Pharmacol 18 (1984): 901-6
  3. Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50
  4. Matheson I, Lunde PK, Notarianni L "Infant rash caused by paracetamol in breast milk." Pediatrics 76 (1985): 651-2
  5. Roberts RJ, Blumer JL, Gorman RL, et al "American Academy of Pediatrics Committee on Drugs: Transfer of drugs and other chemicals into human milk." Pediatrics 84 (1989): 924-36
  6. Notarianni LJ, Oldham HG, Bennett PN "Passage of paracetamol into breast milk and its subsequent metabolism by the neonate." Br J Clin Pharmacol 24 (1987): 63-7

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