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Pregabalin Pregnancy and Breastfeeding Warnings

Pregabalin is also known as: Lyrica

Pregabalin Pregnancy Warnings

Pregabalin has been assigned to pregnancy category C by the FDA. Animal studies have revealed increased incidences of fetal structural abnormalities and other manifestations of developmental toxicity including lethality, growth retardation, and both nervous and reproduction system functional impairment. Animal studies have reported that pregabalin crosses the placenta and have shown an increased risk in male-mediated teratogenicity. There are no controlled data in human pregnancy. Pregabalin should only be given during pregnancy when there are no alternatives and benefit outweighs risk.

Men being treated with pregabalin should be informed of the potential risk of male-mediated teratogenicity. Animal studies have reported increased incidences of specific skull alterations attributed to abnormally advanced ossification, retarded ossification, increased incidences of skeletal malformations, decreased fetal body weights, and visceral variations. When offspring were tested as adults, neurobehavioral abnormalities and reproductive impairment were observed. To provide information regarding the effects of in utero exposure to pregabalin, physicians are advised to recommend that pregnant patients taking pregabalin enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/.

Pregabalin Breastfeeding Warnings

Animal studies have reported pregabalin to be present in milk.

There are no data on the excretion of pregabalin into human milk. Because many drugs are excreted in human milk and because of the potential for tumorigenicity shown for pregabalin in animal studies, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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