The ANSM warns against a potentially fatal misuse of Prodilantin, especially in children under five years old.
Be careful with the use of Prodilantin (sodium fosphenytoin). This drug used in the treatment of epileptic seizures (state of epilepticus of the tonic-clonic type), is the subject of potentially fatal misuse, alert the ANSM this Thursday.
“Medication errors, in particular overdoses, have been reported with Prodilantin” 75mg / ml, explains the National Agency for the Safety of Medicines and Health Products. These overdoses “may be responsible for cardiac arrest and / or death”.
Contraindication in children
These misuses concern in particular children under the age of five, who would be prescribed Prodilantin when the drug is contraindicated in this population. “As a reminder, Prodilantin (sodium fosphenytoin) is not indicated in children under 5 years of age and safety and efficacy have not been established in this population,” recalls the ANSM.
However, some reports mention “a higher percentage, compared to other age groups, of fatal overdose cases” in this population. The status epilepticus in children under 5 years old can be treated with the specialty Dilantin (sodium phenytoin), further specifies the agency.
10 times the dose
Medication errors can result from several factors: “too high doses, too fast infusion rate, too short time between a loading dose and a maintenance dose, confusion over phenytoin sodium equivalents, confusion between the concentration and the total quantity contained in a bottle ”.
These medication errors represent a significant problem due to the use of the product in emergency situations (severe epileptic seizure) and in patients in vulnerable situations. They can indeed be responsible for potentially serious medical sequelae (including fatal cardiac arrests).
Reports of a fatal outcome have in particular been reported in connection with confusion between the concentration (50 mg PE / ml) and the total quantity in the total volume per vial (500 mg PE in 10 ml of Prodilantin) resulting in overdoses of 10 times the dose.
Vigilance
The ANSM therefore alerts the emergency services, SAMU / SMUR, resuscitation / intensive care services, neurology and neurosurgery services, pediatric services, hospital pharmacists, in order to avoid these medication errors. “It is necessary to favor the display of the total quantity of active substance in the total volume (500 mg of PE in 10 ml of Prodilantin) rather than its concentration per ml in computer systems, prescription databases, automatic dispensing cabinets, ordering and storage software to avoid the risk of confusion ”.
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