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Fenoprofen Pregnancy and Breastfeeding Warnings

Fenoprofen is also known as: Fenortho, Nalfon, ProFeno

Medically reviewed on Sep 10, 2018

Fenoprofen Pregnancy Warnings

Avoid use during third trimester of pregnancy.
Prior to 30 weeks gestation: Use is not recommended unless clearly needed.

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.
-If use prior to the third trimester is necessary, the dose should be kept low and duration of use as short as possible.

Animal studies have revealed evidence of an increased risk of miscarriage, pre- and post-implantation loss, gastroschisis, embryo-fetal lethality, and cardiac malformation 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.

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

Fenoprofen Breastfeeding Warnings

Use is not recommended.

Excreted into human milk: Yes

Comments: The effects in the nursing infant are unknown.

Following administration of 600 mg every 6 hours for 4 days in postpartum mothers, breast milk levels of this drug were reported to be 1.6% of those found in maternal plasma. The glucuronide metabolites of this drug may potentially be absorbed by a newborn.

See references

References for pregnancy information

  1. "Product Information. Nalfon (fenoprofen)." Xspire Pharma, Ridgeland, MS.
  2. MHRA. Medicines and Health Regulatory Agency "MHRA Drug Safety Update. Available from: URL: http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate."

References for breastfeeding information

  1. "Product Information. Nalfon (fenoprofen)." Xspire Pharma, Ridgeland, MS.
  2. MHRA. Medicines and Health Regulatory Agency "MHRA Drug Safety Update. Available from: URL: http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate."
  3. 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 -]):

Further information

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

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