This question concerns safety use of trimetoprim, sulfamethoxazol and ciprofloxacin/nduring pregnan

Fråga: This question concerns safety use of trimetoprim, sulfamethoxazol and ciprofloxacin during pregnancy in a patient with cystic fibrosis.

Sammanfattning: Sulfonamides should be avoided near term because of the risk of toxicity in the newborn.

Teratogenic risk of ciprofloxacin in humans has not been established but the drug is not

recommended in pregnant because of findings in animals.

Svar: Trials and case reports on trimetoprim and sulfonamide exposure during pregnancy in

humans have not associated these drugs with an increased risk of congenital abnormalities

(1,2). Jaundice and hemolytic anemia have been observed in newborns exposed to

sulfonamide during the neonatal period. Hyperbilirubinemia and kernicterus can also occur in

newborns (1).

An extensive literature search has not given any documentation of the risk of teratogenicity in

man with ciprofloxacin treatment. In a case report (3) provided by the manufacturer a 3-4

weeks pregnant woman was exposed to ciprofloxacin 500 mg orally twice daily for five days

during a clinical trial. The patient and her child were followed up during pregnancy and for

16 months after delivery. No fetal abnormality and no evidence of joint disease was observed.

However, use of ciprofloxacin is at present not recommended during pregnancy because it

causes cartilage deterioration in young animals and has been associated with arthropathy

(4,5). It has been classified in group B:3 in FASS which means that animal data could

indicate adverse effects in the fetus, although such findings in man have not been reported.

The possible use of antibiotics in pregnant women suffering from cystic fibrosis has

previously been reviewed (6).