Case study: Gaviscon Infant and constipation

Background information

A three-month-old baby boy was prescribed Gaviscon Infant (containing sodium alginate and magnesium alginate) to manage reflux, a condition in which the contents of the stomach come back up into the food pipe. This can be painful and can damage the gullet. Two days after starting the medicine, the baby had severe constipation. As there was no mention of constipation in the Patient Information Leaflet (PIL), the mother contacted their GP who advised them to stop the medication and increase water intake. The baby was also given infacol and miconazole as additional medicines without problems. The baby did not have any relevant medical history of constipation or any other conditions.  

Although the mother was not certain that Gaviscon Infant had caused constipation in her baby, she rightly completed a Yellow Card report as she suspected it might have been the cause. 

Investigation

This report alarmed Medicines and Healthcare products Regulatory Agency (MHRA) experts during routine assessment and a more thorough review was conducted. The review identified 6 additional reports of constipation with Gaviscon Infant in children. Four of these cases were reported by parents, one case was reported by a hospital pharmacist, and one case by a nurse. All cases reported Gaviscon Infant as the only suspect drug. In one case, Gaviscon Infant was stopped, and the child recovered but when the medicine was reintroduced, the child experienced the same side effects. Four cases were recovering or had recovered at the time of reporting upon the withdrawal of the drug. None of the patients had any relevant past medical history that suggested constipation or other medications that might increase the risk of constipation. 

Response

Following thorough assessment by the MHRA specialist unit that looks at medicine use in children; it was decided that this was a possible cause related with Gaviscon Infant and constipation. Gaviscon can be dissolved in water and can thicken solutions, and so stomach contents and potentially intestinal content, resulting in constipation. 

As the product information shows the medicine is for children aged one to two years, it was then agreed that MHRA would contact the pharmaceutical company to request a full review of all cases highlighting the age of patients who experienced constipation. The ages of the patients varied between two weeks to nine months, except for one child who was a one-year-old. It appears that in these cases the product had been used by a healthcare professional in an unapproved patient age group. 

Based on the information received from the pharmaceutical company and the available Yellow Card reports, it was decided to take regulatory action to make the product information clearer with the relevant warnings and precautions.

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