Aspirin / codeine Pregnancy and Breastfeeding Warnings
Aspirin / codeine is also known as: Empirin with Codeine
Aspirin / codeine Pregnancy Warnings
A study of the use of low-dose aspirin (60 mg per day) to prevent and treat preeclampsia in 9364 pregnant women (the Collaborative Low-dose Aspirin Study in Pregnancy--CLASP) did "not support routine prophylactic or therapeutic administration of antiplatelet therapy in pregnancy to all women at increased risk of preeclampsia or IUGR." In that study, no excess of intraventricular hemorrhage, neonatal bleeds, or mortality attributable to bleeding were observed. The investigators did identify a possible role for low-dose aspirin in the treatment of early-onset preeclampsia severe enough to need very preterm delivery. Another study of low-dose aspirin (follow-up from the Italian Study of Aspirin in Pregnancy) has suggested that "low dose aspirin in pregnancy is safe with respect to the risks of malformation and of major impairment in development at 18 months of age." High-dose aspirin (2 g per day) has been associated with stillbirths, cerebral hemorrhage, oculoauriculovertebral dysplasia, neonatal salicylate toxicity, constricted ductus arteriosus, cyclopia, and neonatal acidosis. Some cases of congenital heart defects have been reported. However, a case control study of aspirin use in the first trimester concluded that aspirin "does not increase the risk of congenital heart defects in relation to that of other structural malformations." The frequency of fetal exposure to aspirin reported in many studies may be underestimated because aspirin (and other salicylates) occur in many over-the-counter preparations and women may fail to recall taking aspirin and over-the-counter drugs.
Aspirin-codeine has been assigned to pregnancy category C by the FDA. 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. Increased maternal bleeding can occur during delivery when aspirin is used 1 week prior to and/or during labor and delivery. Prolonged gestation and labor have been reported due to aspirin's inhibition of prostaglandin. Codeine is the only narcotic analgesic which has shown a statistically significant association with teratogenicity (involving respiratory tract malformations) at the time of this writing. Like other narcotics, codeine rapidly crosses the placenta. Neonatal codeine withdrawal has occurred even in infants whose mothers were taking codeine at cough suppressant doses for as little as ten days prior to delivery. There are no controlled data in human pregnancy. Aspirin-codeine should only be given during pregnancy 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.
Aspirin / codeine 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." Codeine is excreted into human milk in small amounts. Several small series and one small retrospective study suggest that codeine may be causative in episodes of apnea, bradycardia and cyanosis in the first week of life. Codeine is nevertheless considered compatible with breast-feeding by the American Academy of Pediatrics.
References for pregnancy information
- 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
- Bracken MB, Holford TR "Exposure to prescribed drugs in pregnancy and association with congenital malformations." Obstet Gynecol 58 (1981): 336-44
- Heinonen O, Slone D, Shapiro S; Kaufman DW ed. "Birth Defects and Drugs in Pregnancy." Littleton, MA: Publishing Sciences Group, Inc. (1977): 297
- Mangurten HH, Benawra R "Neonatal codeine withdrawal in infants of nonaddicted mothers." Pediatrics 65 (1980): 159-60
- Koren G, Pastuszak A, Ito S "Drugs in pregnancy." N Engl J Med 338 (1998): 1128-37
- Karlowicz MG, White LE "Severe intracranial hemorrhage in a term neonate associated with maternal acetylsalicylic acid ingestion." Clin Pediatr (Phila) 32 (1993): 740-3
- Schoenfeld A, Bar Y, Merlob P, Ovadia Y "NSAIDs: maternal and fetal considerations." Am J Reprod Immunol 28 (1992): 141-7
- "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
- "Product Information. Bayer aspirin (aspirin)." Bayer, West Haven, CT.
References for breastfeeding information
- Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50
- 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
- "Product Information. Bayer aspirin (aspirin)." Bayer, West Haven, CT.
- Erickson SH, Oppenheim GL "Aspirin in breast milk." J Fam Pract 8 (1979): 189-90
- Findlay JW, DeAngelis RL, Kearney MF, et al "Analgesic drugs in breast milk and plasma." Clin Pharmacol Ther 29 (1981): 625-33
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