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Nifedipine Pregnancy and Breastfeeding Warnings

Nifedipine is also known as: Adalat, Adalat CC, Afeditab CR, Nifediac CC, Nifedical XL, Procardia, Procardia XL

Medically reviewed on Mar 19, 2018

Nifedipine Pregnancy Warnings

Animal studies have revealed evidence of embryotoxicity, placentotocity, fetotoxicity, and teratogenicity. There are no controlled data in human pregnancy.

Cases of perinatal asphyxia, cesarean delivery, prematurity, and intrauterine growth retardation were reported. Calcium channel blockers (CCBs) have been associated with acute pulmonary edema, especially in patients receiving IV CCBs, those with multiple pregnancy, and/or with concomitant beta-2 agonist use.

Reversible changes in sperm function have occurred with use of CCBs.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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.

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
-Some experts recommend: Use is contraindicated.

AU TGA pregnancy category: C
US FDA pregnancy category:
-Immediate-release capsules: C
-Extended-release tablets: Not assigned.

Risk Summary: This drug has been shown to be teratogenic in animal models.

Comments:
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-Some experts recommend use after week 20 in patients only if all other treatment options are not indicated or have failed to be efficacious.

See references

Nifedipine Breastfeeding Warnings

Immediate-release formulations: Benefit to mother should outweigh risk to the infant.
Extended-release formulations: Use is contraindicated.
-Some experts recommend: Breastfeeding is not recommended during use of this drug.

Excreted into human milk: Yes

Comments:
-This drug is considered compatible with breastfeeding by the American Academy of Pediatrics.
-Some experts recommend delaying breast feeding/milk expression for 3 to 4 hours for patients receiving immediate-release formulations.

See references

References for pregnancy information

  1. "Product Information. Procardia (nifedipine)." Pfizer US Pharmaceuticals, New York, NY.
  2. "Product Information. Adalat (nifedipine)." Bayer, West Haven, CT.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. "Product Information. Adalat (nifedipine)." Bayer, West Haven, CT.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  5. "Product Information. Procardia (nifedipine)." Pfizer US Pharmaceuticals, New York, NY.
  6. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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