Acetaminophen / aluminum hydroxide / aspirin / caffeine / magnesium hydroxide Pregnancy and Breastfeeding Warnings
Acetaminophen / aluminum hydroxide / aspirin / caffeine / magnesium hydroxide Pregnancy Warnings
Aspirin has been assigned to pregnancy category C 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. Aluminum hydroxide and magnesium hydroxide have not been formally assigned to a pregnancy category by the FDA. There are no controlled data in human pregnancy. Other magnesium salts (such as magnesium sulfate) have been used extensively during pregnancy in large doses with no reports of congenital defects. Acetaminophen has not been formally assigned to pregnancy category by the FDA. It is routinely used for short-term pain relief and fever in all stages of pregnancy. Acetaminophen is believed to be safe in pregnancy when used intermittently for short durations. Caffeine has been assigned to pregnancy category B by the FDA. Both human and animal studies have failed to reveal evidence of significant mutagenic or carcinogenic effects. Caffeine crosses the placenta. Fetal blood and tissue levels in the fetus are similar to those in the mother. Caffeine has been reported to be an animal teratogen only with doses high enough to cause toxicity in the mother. In 1980, the Food and Drug Administration issued an advisory (based primarily on animal evidence) which stated that pregnant women should limit there intake of caffeine to a minimum. During the first two trimesters of pregnancy, the combination of acetaminophen, aluminum hydroxide, aspirin, caffeine, and magnesium hydroxide should only be given during pregnancy when clearly needed and when benefit outweighs risk. Because of the aspirin component of this combination drug, during the last trimester of pregnancy, this combination product is only recommended for use when there are no alternatives and benefits outweigh risk.
Acetaminophen / aluminum hydroxide / aspirin / caffeine / magnesium hydroxide Breastfeeding Warnings
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.
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 aluminum hydroxide or magnesium hydroxide into human milk. Because only small amounts of magnesium are systemically absorbed following oral administration of magnesium hydroxide, adverse effects in nursing infants would not be expected. Magnesium salts (like magnesium sulfate) are considered compatible with breast-feeding by the American Academy of Pediatrics. Acetaminophen is excreted into human milk in small concentrations. One case of a rash has been reported in a nursing infant. Acetaminophen is considered compatible with breast-feeding by the American Academy of Pediatrics. Caffeine is excreted into human milk in small amounts. Adverse effects in the nursing infant are unlikely. However, irritability and poor sleep patterns have been reported in nursing infants. The amount of caffeine generally found in caffeinated beverages is considered to usually be 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.
References for pregnancy information
- Beaulac-Baillargeon L, Rocheleau S "Paracetamol pharmacokinetics during the first trimester of human pregnancy." Eur J Clin Pharmacol 46 (1994): 451-4
- 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
- Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
- Galinsky RE, Levy G "Absorption and metabolism of acetaminophen shortly before parturition." Drug Intell Clin Pharm 18 (1984): 977-9
- Karlowicz MG, White LE "Severe intracranial hemorrhage in a term neonate associated with maternal acetylsalicylic acid ingestion." Clin Pediatr (Phila) 32 (1993): 740-3
- Rayburn W, Shukla U, Stetson P, Piehl E "Acetaminophen pharmacokinetics: comparison between pregnant and nonpregnant women." Am J Obstet Gynecol 155 (1986): 1353-6
- Rudolph AM "Effects of aspirin and acetaminophen in pregnancy and in the newborn." Arch Intern Med 141 (1981): 358-63
- Byer AJ, Traylor TR, Semmer JR "Acetaminophen overdose in the third trimester of pregnancy." JAMA 247 (1982): 3114-5
- Miners JO, Robson RA, Birkett DJ "Paracetamol metabolism in pregnancy." Br J Clin Pharmacol 22 (1986): 359-62
- Schoenfeld A, Bar Y, Merlob P, Ovadia Y "NSAIDs: maternal and fetal considerations." Am J Reprod Immunol 28 (1992): 141-7
- Fulton B, James O, Rawlins MD "The influence of age on the pharmacokinetics of paracetamol." Br J Clin Pharmacol 7 (1979): p418
- Levy G, Garrettson LK, Soda DM "Evidence of placental transfer of acetaminophen." Pediatrics 55 (1975): 895
- "Clasp: a randomised trial lf low-dose aspirin for the prevention and treatment of pre-eclampsia among 9364 pregnant women." Lancet 343 (1994): 619-29
- Eskenazi B "Caffeine during pregnancy: grounds for concern? [editorial; comment]." JAMA 270 (1993): 2973-4
- 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
- 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
- "Product Information. Bayer aspirin (aspirin)." Bayer, West Haven, CT.
- Parazzini F, Bortolus R, Chatenoud L, Restelli S, Benedetto C "Follow-up of children in the italian study of aspirin in pregnancy." Lancet 343 (1994): 1235
References for breastfeeding information
- Rose JE, Behm FM "Psychophysiological interactions between caffeine and nicotine." Pharmacol Biochem Behav 38 (1991): 333-7
- Matheson I, Lunde PK, Notarianni L "Infant rash caused by paracetamol in breast milk." Pediatrics 76 (1985): 651-2
- 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
- Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50
- "Product Information. Bayer aspirin (aspirin)." Bayer, West Haven, CT.
- 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
- Erickson SH, Oppenheim GL "Aspirin in breast milk." J Fam Pract 8 (1979): 189-90