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Ketoprofen Pregnancy and Breastfeeding Warnings

Ketoprofen is also known as: Actron, Nexcede, Orudis, Orudis KT, Oruvail

Ketoprofen Pregnancy Warnings

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: 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.

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. 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.

See references

Ketoprofen Breastfeeding Warnings

In a small study where 18 women were given 100 mg IV every 12 hours for 2 to 3 days postpartum, 61 samples were collected between the third and fourth dose; of the 61 samples collected, this drug was undetectable in 17 of the samples. The authors assumed a milk concentration of 20 mcg/L for undetectable samples and calculated an average milk concentration of 57 mcg/L (range 20 to 177 mcg/L). It was estimated that a fully breastfed infant would receive an average dose of 8.5 mcg/kg per day or 0.31% of the maternal weight adjusted dose. Although levels were low, one center reported adverse renal and gastrointestinal side effects in breastfed infants whose mothers were taking this drug; thus other agents may be preferred, especially while nursing a newborn or preterm infant.

Use is not recommended. Excreted into human milk: Unknown Excreted in animal milk: Yes

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References for pregnancy information

  1. "Product Information. Ketoprofen (ketoprofen)." Teva Pharmaceuticals USA, North Wales, PA.
  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. Cerner Multum, Inc. "Australian Product Information." O 0
  5. "Product Information. Ketoprofen ER (ketoprofen)." Mylan Pharmaceuticals Inc, Morgantown, WV.

References for breastfeeding information

  1. "Product Information. Ketoprofen ER (ketoprofen)." Mylan Pharmaceuticals Inc, Morgantown, WV.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Ketoprofen (ketoprofen)." Teva Pharmaceuticals USA, North Wales, PA.
  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. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  6. MHRA. Medicines and Health Regulatory Agency "MHRA Drug Safety Update. Available from: URL: http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate."

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