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Info on Elmiron during Pregnancy
Also posted on "I'm Pregnant" - Just bought the 2004 PDR and wanted to provide you with the information on Elmiron.
"PREGNANCY CATEGORY B
Reproduction studies have been performed in mice and rats with intravenous daily doses of 15 mg/kg, and in rabbits with 7.5 mg/kg. These doses are 0.42 and 0.14 times the daily oral human doses of ELMIRON when normalized to body surface area. These studies did not reveal evidence of impaired fertility or harm to the fetus from ELMIRON. Direct in vitro bathing of cultured mouse embryos with pentosan polysulfate sodium (PPS) at a concentration of 1 mg/mL may cause reversible limb bud abnormalities. Adequate and well controlled studies have not been performed in pregnant women. Because animal studies are not always predictive of human response, this drug should be used in pregnancy only if clearly needed."
Hope that helps you and your doctor make any decisions about whether to stay on it or not. At first, my doctor said it was okay and then re-thought his decision when he got to the part about limb bud adnormalities. So, for now, I'm off of it.
Shubes
"PREGNANCY CATEGORY B
Reproduction studies have been performed in mice and rats with intravenous daily doses of 15 mg/kg, and in rabbits with 7.5 mg/kg. These doses are 0.42 and 0.14 times the daily oral human doses of ELMIRON when normalized to body surface area. These studies did not reveal evidence of impaired fertility or harm to the fetus from ELMIRON. Direct in vitro bathing of cultured mouse embryos with pentosan polysulfate sodium (PPS) at a concentration of 1 mg/mL may cause reversible limb bud abnormalities. Adequate and well controlled studies have not been performed in pregnant women. Because animal studies are not always predictive of human response, this drug should be used in pregnancy only if clearly needed."
Hope that helps you and your doctor make any decisions about whether to stay on it or not. At first, my doctor said it was okay and then re-thought his decision when he got to the part about limb bud adnormalities. So, for now, I'm off of it.
Shubes