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Symptoms of LIORESAL INTRATHECAL OverdoseDrowsinesslightheadednessdizzinesssomnolencerespiratory depressionhypothermiaseizuresrostral progression of hypotonia and loss of consciousness progressing to coma of up to 72 hrdurationIn most cases reportedcoma was reversible without sequelae after drug was discontinuedSymptoms of LIORESAL INTRATHECAL overdose were reported in a sensitive adult patient after receiving a 25 mcg intrathecal bolus.

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.

Limited pharmacokinetic data suggest that a lumbar-cisternal concentration gradient of about 4:1 is established along the neuroaxis during baclofen infusionThis is based upon simultaneous CSF sampling via cisternal and lumbar tap in 5 patients receiving continuous baclofen infusion at the lumbar level at doses associated with therapeutic efficacythe interpatient variability was greatThe gradient was not altered by position.

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