Ortho-McNeil calls off Topamax 100mg tablets

The reason behind the recalling of drugs is related to the complains of uncharacteristic odor associated with the medication caused by trace amounts of TBA (2,4,6 tribromoanisole).

TBA is a byproduct of a chemical preservative sometimes applied to wood often used in the construction of pallets on which products are transported and stored.

The voluntary recall is being implemented in cooperation with the US Food and Drug Administration.

Topamax is indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures and as adjunctive therapy for adults and pediatric patients ages 2 – 16 years with partial onset seizures, or primary generalized tonic-clonic seizures.

It is also indicated for patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome and for adults for the prophylaxis of migraine headache.