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Mefenamic acid Pregnancy and Breastfeeding Warnings

Mefenamic acid is also known as: Ponstel

Mefenamic acid Pregnancy Warnings

Avoid use during last trimester of pregnancy. Prior to 30 weeks gestation: Use only if potential benefit justifies the potential risk to the fetus. AU TGA pregnancy category: C 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: -Avoid use during third trimester as it may cause premature closure of the ductus arteriosus. -Not recommended in women attempting to conceive as may impair female fertility.

Animal studies have revealed evidence of an increased risk of miscarriage, cardiac malformation, gastroschisis, spontaneous abortion, and pre- and post-implantation loss following use of prostaglandin synthesis inhibitors in early pregnancy. Administration of nonsteroidal anti-inflammatory drugs (NSAIDs) during the third trimester of pregnancy may cause significant adverse effects, including premature closure of the fetal ductus arteriosus, pulmonary hypertension, fetal renal impairment, oligohydramnios, and inhibition of platelet aggregation. There are no controlled data in human pregnancy. Administration during labor and delivery is not recommended; onset of labor may be delayed and duration increased with greater bleeding tendency in mother and child. NSAIDs may impair female fertility; withdrawal of NSAID therapy should be considered in women with difficulties conceiving or who are undergoing investigation of infertility. 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 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.

See references

Mefenamic acid Breastfeeding Warnings

Due to lack of published clinical experience in nursing mothers and the potential for toxicity, other agents may be preferred.

Use is not recommended. Excreted into human milk: Yes (in trace amounts) Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. MHRA. Medicines and Health Regulatory Agency "MHRA Drug Safety Update. Available from: URL: http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate."
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. "Product Information. Ponstel (mefenamic acid)." Pfizer U.S. Pharmaceuticals Group, New York, NY.

References for breastfeeding information

  1. 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 -]):
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Ponstel (mefenamic acid)." Pfizer U.S. Pharmaceuticals Group, New York, NY.
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  5. MHRA. Medicines and Health Regulatory Agency "MHRA Drug Safety Update. Available from: URL: http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate."

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