The anti-epileptic drug Epanutin will be out of stock until November in its 50mg Infatabs (phenytoin base) form due to manufacturing delays, Pfizer has announced.
The pharma company revealed that the drug, which is used to control tonic-clonic seizures and partial seizures or both, had fallen victim to delays “despite best efforts”.
It said: “Phenytoin is a Category 1 anti-epileptic drug (AED). The active ingredient in Epanutin 50mg Infatabs and Dilantin 50mg Infatabs is the same, however in the absence of bioequivalence data, there may be clinically relevant differences between the two products.
“Any switches to different presentations must be managed under medical supervision and monitoring of phenytoin serum levels to ensure the correct dosage is being given.”
While the oral suspension of the drug remains available, supplies are only sufficient to meet market demand and therefore patients should not be switched to this preparation, so as not to cause a shortage of this as well, Pfizer stressed.
Full information on the shortage and the recommended equivalent – including information for prescribers – is available.