Spiriva in Pregnancy

[Cheryl Laubacher]

Hello. Is there any information in using Sprivia (tiotropium) during pregnancy?
Thank you,
Cheryl

[Sandra]

Cheryl Laubacher,

Spiriva is rated a P3 – Unknown, risk to the fetus cannot be ruled out. "No evidence of tumorigenicity was observed in a 104-week inhalation study in rats at tiotropium doses up to 0.059 mg/kg/day, in an 83-week inhalation study in female mice at doses up to 0.145 mg/kg/day, and in a 101-week inhalation study in male mice at doses up to 0.002 mg/kg/day. These doses correspond to approximately 25, 35, and 0.5 times the recommended human daily inhalation dose (RHDID) on a mg/m2 basis, respectively.

Tiotropium bromide demonstrated no evidence of mutagenicity or clastogenicity in the following assays: the bacterial gene mutation assay, the V79 Chinese hamster cell mutagenesis assay, the chromosomal aberration assays in human lymphocytes in vitro and mouse micronucleus formation in vivo, and the unscheduled DNA synthesis in primary rat hepatocytes in vitro assay. In rats, decreases in the number of corpora lutea and the percentage of implants were noted at inhalation tiotropium doses of 0.078 mg/kg/day or greater (approximately 35 times the RHDID on a mg/m2 basis). No such effects were observed at 0.009 mg/kg/day (approximately 4 times than the RHDID on a mg/m2 basis). The fertility index, however, was not affected at inhalation doses up to 1.689 mg/kg/day (approximately 760 times the RHDID on a mg/m2 basis). These dose multiples may be over-estimated due to difficulties in measuring deposited doses in animal inhalation studies.

At present there is no evidence of fetal structural abnormalities in rats or rabbits at elevated doses. These doses correspond to approximately 660 and 6 times the RHDID on a mg/m2 basis, respectively. However, in rats, fetal resorption, litter loss, decreases in the number of live pups at birth and the mean pup weights, and a delay in pup sexual maturation were observed at inhalation tiotropium doses of ≥0.078 mg/kg (approximately 35 times the RHDID on a mg/m2 basis).

There are no adequate and well-controlled studies in pregnant women." (Medications and Mothers' Milk database, Dr Thomas Hale PhD).

Sandra Lovato R.N.
InfantRisk Center