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Caffeine Pregnancy and Breastfeeding Warnings

Caffeine is also known as: 357 HR Magnum, Alert, Cafcit, Caffedrine, ConRx Alert, Diurex Maximum Relief Water Caps, Diurex Ultra, Enerjets, Fastlene, Keep Alert, Keep Going, Lucidex, Molie, NoDoz, NoDoz Maximum Strength, Overtime, Pep-Back Peak Performance, Pep-Back Ultra, Stat Awake, Stay Alert, Stay Awake, Valentine, Verv, Vivarin, Wakespan

Caffeine Pregnancy Warnings

The drug 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. 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.

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. Furthermore, caffeine was not associated with infertility in 1818 infertile women and their primiparous controls. In another study (n=441) no evidence was found that moderate caffeine use increased the risk of spontaneous abortion, intrauterine growth retardation, or microcephaly. One study (n=18,478) on the consumption of coffee (with caffeine regarded as the key component in studies of the potential effects of coffee) found that pregnant women who drank 8 or more cups of coffee a day had more than twice the risk of delivering a stillbirth compared with women who did not drink coffee during pregnancy. However, as one letter regarding this study states, the "article raises more issues than it settles" including how much of increase in stillbirths was actually due to the increase in caffeine consumption. Another letter responding to this study claims that consumption of 8 or more cups of coffee is suggestive of addictive behavior. Those with addictive behavior are more likely to be smokers, have a high intake of alcohol, and use illegal drugs. Other questions regarding this study were also raised. Therefore, it has been questioned if the increased risk of delivering a stillbirth that the study associated with consumption of 8 or more cups of coffee per day can be associated with increased risk from increased caffeine consumption.

Caffeine 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. 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.

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