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Diclofenac topical Pregnancy and Breastfeeding Warnings

Diclofenac topical is also known as: Diclo Gel with Xrylix, Diclozor, Flector Patch, Klofensaid II, Lexixryl, Pennsaid, Solaraze, Voltaren Gel, Xrylix

Medically reviewed on May 25, 2018

Diclofenac topical Pregnancy Warnings

Animal studies have revealed evidence of an increased risk of miscarriage, pre- and post-implantation loss, gastroschisis, embryo-fetal lethality, and cardiac malformation following systemic 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 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 D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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

AU TGA pregnancy category: C
US FDA pregnancy category: B (3% gel)
US FDA pregnancy category: C prior to 30 weeks gestation; D starting at 30 weeks gestation (topical solutions, patch, 1% gel)

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

Diclofenac topical Breastfeeding Warnings

Use is not recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-Following oral administration, this drug was detectable in human breast milk.
-This drug should not be applied to the breasts of nursing mothers.

See references

References for pregnancy information

  1. "Product Information. Voltaren Topical (diclofenac topical)." Endo Laboratories LLC, Chadds Ford, PA.
  2. "Product Information. Solaraze (diclofenac topical)" SkyePharma, San Diego, CA.
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. "Product Information. Pennsaid (diclofenac topical)." Horizon Pharma USA Inc, Northbrook, IL.
  5. "Product Information. Flector Patch (diclofenac topical)." Actavis U.S. (Alpharma USPD), Owings Mills, MD.
  6. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. "Product Information. Solaraze (diclofenac topical)" SkyePharma, San Diego, CA.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. "Product Information. Pennsaid (diclofenac topical)." Horizon Pharma USA Inc, Northbrook, IL.
  5. "Product Information. Flector Patch (diclofenac topical)." Actavis U.S. (Alpharma USPD), Owings Mills, MD.
  6. "Product Information. Voltaren Topical (diclofenac topical)." Endo Laboratories LLC, Chadds Ford, PA.
  7. 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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