In FASS it is stated that Ibuprofen (ACO) should be used with precaution in patients with epilepsy.

Fråga: In FASS it is stated that Ibuprofen (ACO) should be used with precaution in patients with epilepsy. This is not stated in FASS for the other ibuprofen preparations (Ibumetin, Brufen). The doctor wonders why.

Sammanfattning: There is no scientific support for the statement that ibuprofen should be used with special caution in epileptic patients. It was introduced early for safety reasons on the basis of two case reports. The drug producer ACO will take away this statement in the forthcoming version of FASS 1989.

Svar: Only one study is available on 126 cases of ibuprofen overdose where two cases of seizures were reported (1). One 16-month-old child ingested 469 mg/kg ibuprofen by history. The child developed apneic episodes followed by an aspiration pneumonitis and sepsis, and also had generalized seizures. This patient died on the seventh day after hospital admission. Another 5-year-old child had one generalized seizure within four hours of ingesting an unknown amount of ibuprofen. This patient recovered fully. There is no information, however, concerning seizures caused by ibuprofen at normal therapeutic doses.

The drug manufacturer ACO was contacted for the reasons of its statement in FASS. When they introduced ibuprofen into market the FASS text that "it should be used with precaution in patient of epilepsy" was copied from the manufacturer of Ibumetin, Alfred Benzon. ACO has kept this statement in FASS even after Alfred Benzon has taken it away. Now ACO is going to omit this sentence in the forthcoming FASS 1989 since there is no documentation for it.

Nevertheless, cramps or seizures connected with indomethacin therapy (2) and generalized convulsions in a breast-fed infant whose mother has taken indomethacin (3) have been reported. To the National Board of Health and Welfare´s ADRs registery, five cases of seizures (convulsions) have been reported for indomethacin during 1970 and 1984.