Carcinogenesis, Mutagenesis, Impairment of Fertility
Amlexanox was not carcinogenic when administered orally to rats for two years and to mice for 18 months. In vitro (Ames) and in vivo (mouse micronucleus) mutagenicity tests of amlexanox were negative. Amlexanox at doses up to two hundred times the projected human daily dose, on a mg/m² basis, did not significantly affect fertility or general reproductive performance in rats.
Pregnancy Category B
Teratology studies were performed with rats and rabbits at doses up to two hundred and six hundred times, respectively, the projected human daily dose, on a mg/m² basis. No adverse fetal effects were observed. At doses up to two hundred times the projected human daily dose, on a mg/m² basis, amlexanox did not have significant effect on peri- and postnatal development of rat fetuses. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Amlexanox was found in the milk of lactating rats; therefore, caution should be exercised when administering amlexanox oral paste, 5%, to a nursing woman.
Safety and effectiveness of amlexanox oral paste, 5%, in pediatric patients have not been established.
Clinical studies of Aphthasol (amlexanox) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Last reviewed on RxList: 6/2/2009
This monograph has been modified to include the generic and brand name in many instances.
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