Cevimeline
Risk Factor: CM
Class: AUTONOMICS
/ Parasympathomimetics (Cholinergics)
Contents of this page:
Fetal Risk Summary
Breast Feeding Summary
References
Questions and Answers
Fetal Risk Summary
Cevimeline is an oral cholinergic agonist indicated for the treatment of dry mouth in patients with Sjgren's syndrome.
In reproduction studies with rats, a dose, approximately 5 times the recommended human dose for a 60-kg person on a body surface area basis, given from 14 days before mating through day 7 of gestation, caused a reduction in the mean number of implantations. This effect may have been due to maternal toxicity (1).
No studies examining the placental transfer of cevimeline have been located. The molecular weight (about 245 for the hydrated salt form) is low enough, however, that passage to the fetus should be expected.
No studies describing the use of cevimeline during human pregnancy have been located. The very limited animal data, which did not include exposure during organogenesis, and the lack of any reported human pregnancy experience, prevents an assessment of the risk that this drug presents to a fetus.
Breast Feeding Summary
No reports describing the use of cevimeline in human lactation have been located. The molecular weight (about 245 for the hydrated salt form) suggests that excretion into breast milk should be expected. Because the effects of this exposure on a nursing infant are unknown, combined with the lack of data on the amount of drug that may be in milk, women who are taking cevimeline should probably not breast feed.
References
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Product information. Evoxac. Daiichi Pharmaceutical, 2001.
