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Ketoprofen Pregnancy and Breastfeeding Warnings

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

Medically reviewed by Drugs.com. Last updated on Mar 11, 2021.

Ketoprofen Pregnancy Warnings

Contraindicated last trimester of pregnancy
NSAIDs should be avoided at 20 weeks gestation and later

AU TGA pregnancy category: C
US FDA pregnancy category: C

Risk Summary: Nonsteroidal anti-inflammatory drugs (NSAIDs) use in pregnant women at 30 weeks gestation and later may cause premature closure of the fetal ductus arteriosus; NSAID use at 20 weeks gestation or later may cause fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.

Comments:
-NSAID use in pregnancy prior to 20 weeks gestation should be based on a benefit-risk assessment; some authorities recommend avoiding NSAIDs throughout pregnancy whenever possible.
-If NSAID use is necessary between 20- and 30-weeks' gestation, limit use to the lowest effective dose for the shortest duration possible; ultrasound monitoring of amniotic fluid should be considered if NSAID use extends beyond 48 hours; if oligohydramnios occurs, discontinue NSAID and treat appropriately.
-NSAID use is not recommended in women attempting to conceive as it 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.

US FDA Drug Safety Communication (10-2020): The FDA is requiring a new warning be added to NSAID labeling describing the risk of fetal kidney problems that may result in low amniotic fluid. The FDA is recommending pregnant women avoid NSAID use at 20 weeks gestation or later. Through 2017, the FDA has received 35 reports of low amniotic fluid levels or kidney problems in mothers who took NSAIDs while pregnant. Five newborns died; 2 had kidney failure and confirmed low amniotic fluid, 3 had kidney failure without confirmed low amniotic fluid. The low amniotic fluid started as early as 20 weeks of pregnancy. There were 11 reports of low amniotic fluid levels during pregnancy and the fluid volume returned to normal after the NSAID was stopped. The medical literature has reported low amniotic fluid levels with use of NSAIDs for varying amounts of time, ranging from 48 hours to multiple weeks. Complications of prolonged oligohydramnios may include limb contractures and delayed lung maturation. In some postmarketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required. In other cases, the condition was reversible within 3 to 6 days of stopping the NSAID and in these cases reappeared when the same NSAID was restarted.
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

See references

References for pregnancy information

  1. US Food and Drug Administration "FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid. Available from: URL: https://www.fda.gov/media/142967/download." ([2020, Oct 15]):
  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.
  6. "Product Information. Ketoprofen (ketoprofen)." Teva Pharmaceuticals USA, North Wales, PA.

References for breastfeeding information

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

Further information

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