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Diflunisal Pregnancy and Breastfeeding Warnings

Diflunisal is also known as: Dolobid

Medically reviewed on Sep 10, 2018

Diflunisal Pregnancy Warnings

Animal studies have revealed evidence of embryotoxicity and teratogenicity at higher doses that also produced maternal toxicity. Aspirin and other salicylates have shown evidence of teratogenicity in animal studies at doses ranging from 1 to 8 times the human dose. 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, prolongation of bleeding time, tricuspid incompetence, intracranial bleeding, fetal renal impairment, oligohydramnios, gastrointestinal bleeding or perforation, and increased risk of necrotizing enterocolitis. Administration during labor and delivery in rat studies caused an increased incidence of dystocia, delayed parturition, and decreased pup survival. There are no controlled data in human pregnancy.

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 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.

Use should be avoided during the third trimester of pregnancy; according to some authorities, use is contraindicated.
Prior to third trimester: Use only if potential benefit justifies the potential risk to the fetus.

US FDA pregnancy category: C

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.

See references

Diflunisal Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes

Comments: The effects in the nursing infant are unknown.

Milk levels range from 2% to 7% of simultaneous maternal serum levels after 7 days of administration of 125 or 250 mg twice a day. This would represent milk levels ranging from 0.3 to 0.9 mg/L with a dose of 125 mg/day and 0.8 to 2.7 mg/L with a dose of 250 mg/day. A shorter-acting agent with more published information available may be preferred, especially while nursing a newborn or preterm infant.

See references

References for pregnancy information

  1. MHRA. Medicines and Health Regulatory Agency "MHRA Drug Safety Update. Available from: URL: http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate."
  2. "Product Information. Dolobid (diflunisal)." Merck & Co, Inc, West Point, PA.

References for breastfeeding information

  1. MHRA. Medicines and Health Regulatory Agency "MHRA Drug Safety Update. Available from: URL: http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate."
  2. "Product Information. Dolobid (diflunisal)." Merck & Co, Inc, West Point, PA.
  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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