Caffeine / magnesium salicylate Pregnancy and Breastfeeding Warnings

Brand names: Diurex

Caffeine / magnesium salicylate Pregnancy Warnings

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.

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."

Caffeine-magnesium salicylate has not been formally assigned to a pregnancy category by the FDA. Caffeine in general has not been formally assigned to pregnancy category by the FDA. However, caffeine citrate injection has been assigned to pregnancy category C by the FDA. Briggs et al. assigns caffeine to risk factor B. 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 have been reported to be similar to those in the mother. Two cases of possible maternal caffeine-induced hypokalemic paralysis has been reported. 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 their intake of caffeine to a minimum. Magnesium salicylate has not been formally assigned to pregnancy category by the FDA. Briggs et al. considers salicylates and aspirin to be interchangable in consideration of risk in human pregnancy and assigns it to pregnancy risk factor C except when used full-dose in 3rd trimester when it is risk factor D. 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. During the first two trimesters of pregnancy, aspirin should only be given during pregnancy when clearly needed and 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.

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Caffeine / magnesium salicylate Breastfeeding Warnings

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. Caffeine is reported as compatible with breastfeeding by Briggs et al.

Salicylate 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 salicylate can result in rashes, platelet abnormalities, and bleeding in nursing infants. Salicylate is reported as compatible with breastfeeding by Briggs et al. Because of a single case report of metabolic acidosis, the American Academy of Pediatrics characterizes salicylate as a drug that has been "associated with significant effects on some nursing infants and should be given to nursing mothers with caution."

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Further information

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