Amlodipine and celecoxib Pregnancy Warnings
Animal studies with amlodipine have revealed decreased litter size (by about 50%) and increased intrauterine deaths (about 5-fold) at doses approximately 10 times the MRHD. Animal studies with celecoxib have revealed structural abnormalities at doses approximately 2 times the maximum recommended human dose (MRHD) and embryofetal lethality at doses approximately 6 times the MRHD. There are no controlled data in human pregnancy.
The nonsteroidal anti-inflammatory drug (NSAID) may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women.
US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.
Use should be avoided starting at 30 weeks of gestation (third trimester); consider withdrawal of this drug in women who have difficulties conceiving or who are undergoing investigation of infertility; pregnant women with hypertension should be carefully monitored and managed accordingly.
US FDA pregnancy category: Not assigned
Risk Summary: Use of nonsteroidal anti-inflammatory drugs (NSAIDs) during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus.
Comments:
-Advise females of reproductive potential who desire pregnancy that NSAIDs may be associated with a reversible delay in ovulation.
-Advise females of reproductive potential to contact their healthcare provider with a known or suspected pregnancy.
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Amlodipine and celecoxib Breastfeeding Warnings
An observational clinical lactation study of 31 lactating women estimated the infant dose of amlodipine to be 1.7% to 3.3% of the recommended dose for an average 6-year old (20 kg). Two clinical lactation studies that included a total of 11 breastfeeding women estimated the infant dose of celecoxib to be 0.1% to 0.33% of the clinically used dose for pediatric patients.
The manufacturer makes no recommendation regarding use during lactation.
Excreted into human milk: Yes (amlodipine, celecoxib)
Comments: The individual components have been used without apparent harmful effects in the nursing infant.
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