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Acetaminophen / caffeine Pregnancy and Breastfeeding Warnings

Acetaminophen / caffeine is also known as: Excedrin Mild Headache, Excedrin Quick Tab, Excedrin Tension Headache, Headache Relief, Valorin Extra

Acetaminophen / caffeine Pregnancy Warnings

-Some experts say that acetaminophen-caffeine should not be taken during pregnancy due to the risk of lower birth weight and spontaneous abortion associated with caffeine consumption. -Two cases of acetaminophen overdose in late pregnancy have been reported. In both cases neither the neonate nor the mother suffered hepatic toxicity. -Caffeine levels in fetal blood and tissue have been similar to those in the mother. -Caffeine has been reported to be an animal teratogen; however, only with doses high enough to cause toxicity in the mother. -In a study of 2817 fertile women, no evidence of adverse effects from caffeine was found. The fecundability ratio (adjusted for known risk factors for time to conceive) was 1.03 between fertile women who consumed more than 7000 mg caffeine per month and those who consumed 500 mg or less per month. Caffeine was not associated with infertility in 1818 infertile women. In another study (n=441) no evidence was found that moderate caffeine use increased the risk of spontaneous abortion, intrauterine growth retardation, or microcephaly. AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

(AU, UK): Use is not recommended. (US, CA): This drug should be used during pregnancy only if clearly needed. AU TGA pregnancy category: -Paracetamol: A -Caffeine: Not formally assigned to a pregnancy category. US FDA pregnancy category: -Acetaminophen: Not formally assigned to a pregnancy category. -Caffeine: B Comments: -Acetaminophen is routinely used for short-term pain relief and fever in all stages of pregnancy. It is believed to be safe in pregnancy when used intermittently for short durations. -Caffeine crosses the placenta. Both human and animal studies have failed to reveal evidence of significant mutagenic or carcinogenic effects.

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Acetaminophen / caffeine Breastfeeding Warnings

(AU, UK): Use is not recommended due to the caffeine content. (US, CA): Acetaminophen is considered compatible with breast-feeding by the American Academy of Pediatrics. Because caffeine is excreted into human milk and because caffeine is metabolized slowly by nursing infants, consumption of more than moderate levels of caffeine by nursing mothers is not recommended. Excreted into human milk: Yes (acetaminophen, caffeine) Comments: -Adverse effects in the nursing infant are unlikely. However, irritability and poor sleep patterns have been reported in nursing infants from the caffeine component.

Acetaminophen is excreted into human breast milk but in clinically insignificant amounts. One small study has reported that following a 1000 mg dose of paracetamol to nursing mothers, nursing infants receive less than 1.85% of the weight-adjusted maternal oral dose. Paracetamol is not contraindicated in lactating mothers based on current published data. Studies show that caffeine is excreted into human breast milk and cases of irritability and poor sleeping in the infant have been reported. Caffeine in breast milk may potentially have a stimulating effect on the breast fed infant.

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References for pregnancy information

  1. Miners JO, Robson RA, Birkett DJ "Paracetamol metabolism in pregnancy." Br J Clin Pharmacol 22 (1986): 359-62
  2. Mills JL, Holmes LB, Aarons JH, Simpson JL, Brown ZA, Jovanovic-Peterson LG, Conley MR, Graubard BI, Knopp RH, Metzger BE "Moderate caffeine use and the risk of spontaneous abortion and intrauterine growth retardation [see comments." JAMA 269 (1993): 593-7
  3. Eskenazi B "Caffeine during pregnancy: grounds for concern? [editorial; comment]." JAMA 270 (1993): 2973-4
  4. Levy G, Garrettson LK, Soda DM "Evidence of placental transfer of acetaminophen." Pediatrics 55 (1975): 895
  5. Beaulac-Baillargeon L, Rocheleau S "Paracetamol pharmacokinetics during the first trimester of human pregnancy." Eur J Clin Pharmacol 46 (1994): 451-4
  6. Joesoef MR, Beral V, Rolfs RT, Aral SO, Cramer DW "Are caffeinated beverages risk factors for delayed conception? [see comments." Lancet 335 (1990): 136-7
  7. Rudolph AM "Effects of aspirin and acetaminophen in pregnancy and in the newborn." Arch Intern Med 141 (1981): 358-63
  8. Galinsky RE, Levy G "Absorption and metabolism of acetaminophen shortly before parturition." Drug Intell Clin Pharm 18 (1984): 977-9
  9. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  10. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  11. Byer AJ, Traylor TR, Semmer JR "Acetaminophen overdose in the third trimester of pregnancy." JAMA 247 (1982): 3114-5
  12. 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

References for breastfeeding information

  1. Berlin CM Jr, Denson HM, Daniel CH, Ward RM "Disposition of dietary caffeine in milk, saliva, and plasma of lactating women." Pediatrics 73 (1984): 59-63
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Rose JE, Behm FM "Psychophysiological interactions between caffeine and nicotine." Pharmacol Biochem Behav 38 (1991): 333-7
  4. Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50
  5. Matheson I, Lunde PK, Notarianni L "Infant rash caused by paracetamol in breast milk." Pediatrics 76 (1985): 651-2
  6. 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

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