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One patienta 44 year-old male with MSdied in hospital on the second day following pump implantationAn autopsy demonstrated severe fibrosis of the coronary conduction systemA second patienta 52 year-old woman with MS and a history of an inferior wall myocardial infarctionwas found dead in bed 12 days after pump implantation2 hours after having had documented normal vital signsAn autopsy revealed pulmonary congestion and bilateral pleural effusionsIt is impossible to determine whether LIORESAL INTRATHECAL contributed to these deathsThe third patient underwent three baclofen screening trialsHis medical history included SCIaspiration pneumoniaseptic shockdisseminated intravascular coagulopathysevere metabolic acidosishepatic toxicityand status epilepticusTwelve days after screeninghe was not implantedhe again experienced status epilepticus with subsequent significant neurological deteriorationBased upon prior instructionextraordinary resuscitative measures were not pursued and the patient died.
On each occasion that the dosing rate of the pump and/or the concentration of LIORESAL INTRATHECALbaclofen injectionin the reservoir is adjustedclose medical monitoring is required until it is certain that the patient’s response to the infusion is acceptable and reasonably stable.
Reservoir refilling must be performed by fully trained and qualified personnel following the directions provided by the pump manufacturerInadvertent injection into the subcutaneous tissue can occur if the reservoir refill septum is not properly accessedSubcutaneous injection may result in symptoms of a systemic overdose or early depletion of the reservoirRefill intervals should be carefully calculated to prevent depletion of the reservoiras this would result in the return of severe spasticity and possibly symptoms of withdrawal.
LIORESAL INTRATHECAL is for use in single bolus intrathecal injectionsvia a catheter placed in the lumbar intrathecal space or injection by lumbar punctureand in implantable pumps approved by the FDA specifically for the intrathecal administration of baclofenBecause of the possibility of potentially life-threatening CNS depressioncardiovascular collapseand/or respiratory failurephysicians must be adequately trained and educated in chronic intrathecal infusion therapy.
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