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Focus on correct dose of Pro-Epanutin

24 June 2014

The Danish Health and Medicines Authority encourages hospitals to pay special attention to the risk of dose errors of the anticonvulsant medicine Pro-Epanutin.

The reason is that the National Agency for Patients' Rights and Complaints has identified 16 incidents in the Danish Patient Safety Database, all of which are about healthcare professionals who have been unsure about the use of the anticonvulsant medicine Pro-Epanutin.

Pro-Epanutin is a concentrate for injection fluid, which is used in emergencies, such as febrile seizures in children or epileptic seizures. Pro-Epanutin is used very rarely and some departments do not have the medicine as part of their standard product range because the medicine is not the first choice of treatment in case of acute seizures. Consequently, some of the healthcare professionals are not familiar with the medicine which increases the risk of dose errors.

Confusion occurs because Pro-Epanutin contains the substance fosphenytoin. When Pro-Epanutin is injected into the body, fosphenytoin is converted to the active substance phenytoin, but the conversion does not take place on a 1:1 basis. This confuses the healthcare professionals and increases the risk of dose errors.

The confusion has caused two serious incidents, one of which led to cardiac arrest and the other to poisoning and subsequent severe liver and renal impairment as well as damage to muscle tissue. The other incidents caused no injury to the patients.

To reduce the risk of dose errors in future, the Danish Health and Medicines Authority, the relevant pharmaceutical company and the National Agency for Patients' Rights and Complaints have published information about this issue to draw healthcare professionals' attention to the problem.

Healthcare professionals at the hospitals are encouraged to:

  • pay attention to the risk of dose errors
  • review the newest package leaflet or summary of product characteristics and update the department's instructions according to the current product information
  • increase focus on the safety of the general handling of the medicine.

The information was published by the National Agency for Patients' Rights and Complaints on Monday 23 June 2014: Doubt about dose of Pro-Epanutin (fosphenytoin) (in Danish)

In addition, the Danish Health and Medicines Authority is in dialogue with the pharmaceutical company and other European regulatory authorities about more preventive initiatives to avoid dose errors of the anticonvulsant medicine Pro-Epanutin.