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). 1 FASS (The Swedish catalogue of approved medical products) 1998; 1162 2 Walker JJ, Johnstone J, Lloyd J, Rocha CL: The transfer of ketorolac tromethamine from maternal to foetal blood. Eur J Clin Pharmacol 1988; 34: 509-511 3 Walker JJ, Johnston J, Fairlie FM, Lloyd J: A comparative study of intramuscular ketorolac and pethidine in labour pain. Eur J Obst Gyn Repr Biol 1992; 46: 87-94

4 Motherisk statements, Hospital for sick children, Toronto, Canada
5 SADRAC (The Swedish adverse reactions advisory committee):s adverse drug reactions database
6 Drugline nr 11469 (year 1994)
7 Drugline nr 10317 (year 1994)
8 Drugline nr 10530 (year 1993)
9 Drugline nr 09507 (year 1992)
10 Drugline nr 08532 (year 1991)
11 Drugline nr 05667 (year 1987)

12 Drugline nr 03694 (year 1983)