A 5-week-old boy has been prescribed 2.5 ml twice daily of dicycloverine (dicyclomine) one mg/ml mi

Fråga: A 5-week-old boy has been prescribed 2.5 ml twice daily of dicycloverine (dicyclomine) one mg/ml mixture against colic. When the child was 2.5 months old, the dose was increased to 5 ml twice daily. Just after this he experienced a tonic cramp with no eye-contact, which lasted for approximately 1/2 a minute. He was hospitalised and the EEG was normal. The drug was withdrawn. Two more times within a month the child had similar symptoms but it is unclear whether the drug was reinstituted or not. The questioner would like information concerning convulsions induced by dicycloverine. He is aware of the literature up to 1989 when he was in contact with DRIC.

Sammanfattning: Convulsions have been reported to occur during treatment with dicycloverine. However, no new information concerning this has been found in the literature from the last six years.

Svar: Dicycloverine is an orphan drug. It is an anticholinergic with an antispasmolytic effect on smooth muscles in the gastrointestinal tract. It is prescribed in Sweden as mixture one mg/ml with the indications infant colic symptoms. In 1985 the Medical Product Agency informed physicians about the use of the drug in medical care. They focused on the increase of reported side-effects and noted that physicians should be more restricted in prescribing the drug only to infants with troublesome colic symptoms and to inform the parents carefully about its side-effects (1).

Abroad, dicycloverine has been used for many years. For example in Britain it has been used for more than 40 years, with a broader indication but with contra-indications for children under 6 months of age.

In Sweden it is not recommended that dicycloverine be given to children under one month of age (2). Convulsions have been reported (3). In a new literature search no further information concerning side-effects such as convulsions, seizures or apnoea could be found. Very little information concerning dicycloverine have been published during the last ten years (4).

From 1982 to 1994, 28 reports of side-effects have been registered at SADRAC. These include five cases of lethargy, four apnoea, three disturbance of consciousness, one muscle cramp and two convulsions (5). We recommend that this case be reported to SADRAC.