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Generic Name
Diclofenac and misoprostol
Trade Name
Arthrotec 75
Manufacturer
Searle
Risk Category
X
  • Positive evidence of human fetal risk exists.
  • Potential benefits may warrant use of the drug in pregnant women despite potential risks (e.g. life threatening situations or serious illness).
  • Studies in animals and/or humans have demonstrated fetal abnormalities.
  • Fetal risk involved in use of drug, clearly outweighs potential benefit.
  • Contraindicated in women who are or may become pregnant. Don’t use.
FDA Pregnancy Risk Categories

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Indication
Indication
  • Anti-inflammatory non-steroidal.
  • Antacid, synthetic PG E1 analogue.
  • Fetal Risk
    Fetal Risk
  • Diclofenac is teratogenic is some animals causing cleft palate is a split in roof of the mouth, due to failure of two sides to fuse during embryonic development. Could also be a cleft lip, which is a split in the lip">cleft palate and at maternal toxic doses it causes intrauterine growth retardation, decreased fetal survival and prolonged pregnancy.
  • No well-controlled human data but no association with congenital anomalies has been reported.
  • If used in 3rd trimester it can cause constriction of pulmonary artery to aorta">ductus arteriosus with subsequent neonatal pulmonary hypertension, oligohydramnios as a result of impaired fetal renal function. Misoprostol is not teratogenic or toxic in animals: Contraindicated in pregnancy because it induces abortion.
  • Following unsuccessful 1st trimester abortion, it is teratogenic producing limb, digital, skull defects and gastroschisis.
  • Bilateral palsy of cranial nerves (moebius sequence) and cleft palate is a split in roof of the mouth, due to failure of two sides to fuse during embryonic development. Could also be a cleft lip, which is a split in the lip">cleft lip and palate.
  • Breast Feeding
    Breast Feeding
  • Both agents are excreted into milk.
  • Diclofenac is safe.
  • Misoprostol is contraindicated in breast feeding, causes diarrhea in nursing infants.
  • Other Trade Names
     
    The information on this Web site is not intended as a substitute for the advice and care of your doctor or other health-care provider. Always consult your doctor if you have any questions about exposures during pregnancy and lactation, and before you take any medications. Please read the Terms and Conditions before using this website.
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