Frågedatum: 1998-09-30
RELIS database 1998; id.nr. 14739, DRUGLINE
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Is there a risk for teratogenicity of ketorolac (Toradol)?/nA 36-year-old woman received ketorolac



Fråga: Is there a risk for teratogenicity of ketorolac (Toradol)? A 36-year-old woman received ketorolac during surgery in gestation week 7.

Sammanfattning: In summary, the risk of ketorolac administration during pregnancy appears to be similar to the risk of other NSAID. There are no conclusive data indicating an increased risk of teratogenicity in humans caused by NSAID. Ketorolac intake is not considered an indication for abortion.

Svar: Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) used for short-term management of pain (1). When given to pregnant women in labour in one study, ketorolac concentrations in cord blood were very low and cord:maternal levels following intramuscular administration in labour were 1:4 (2). In another study a comparison between intramuscular ketorolac and pethidine during labour was carried out. No adverse effect occurred in mother or fetus in either group, but maternal sedation and fetal depression were statistically less in the ketorolac group (3).

Teratology studies in pregnant rats and rabbits, in doses up to 10 mg/kg/day (15 times the recommended human dose) revealed no evidence of embryotoxicity or malformations (4). A Medline search did not reveal any published studies of ketorolac use in pregnant women.

In the Swedish database of adverse drug reactions, there are no cases about ketorolac and pregnancy (5).

The question about NSAID and teratogenicity has been dealt with several times previously at the Drug Information Centers (6-12). These documents reveal no conclusive data indicating an increased risk of malformations in the offspring of mothers exposed to NSAID. NSAID used during late pregnancy has been shown to inhibit labour and to prolong pregnancy. NSAID used near-term might also cause constriction of the ductus arteriosus in utero and fetal pulmonary hypertension as well as increased risk of intracranial hemorrhage (8). Therefore NSAID is classified "C" in Sweden, that is, the drug has produced/or could be expected to produce, a risk for the fetus and/or the newborn child without directly causing malformations (12).

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