warnings and cautions
5 WARNINGS AND PRECAUTIONS Abrupt discontinuation of baclofen has resulted in serious adverse reactions including death; therefore, reduce the dosage slowly when baclofen oral solution is discontinued. ( 5.1 ) Neonatal withdrawal symptoms can occur; gradually reduce the dosage and discontinue baclofen oral solution before delivery. ( 5.2 ) Baclofen oral solution can cause drowsiness and sedation. Patients should avoid the operation of automobiles or other dangerous machinery until they know how the drug affects them. Advise patients that the central nervous system effects of baclofen oral solution may be additive to those of alcohol and other CNS depressants. ( 5.3 ) Baclofen oral solution can cause exacerbation of the following: psychotic disorders, schizophrenia, or confusional states; autonomic dysreflexia; epilepsy. Use with caution in patients with these conditions ( 5.5 , 5.6 , 5.7 ) 5.1 Adverse Reactions From Abrupt Withdrawal of Baclofen Oral solution Abrupt discontinuation of baclofen, regardless of the cause, has resulted in adverse reactions that include hallucinations, seizures, high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure, and death. Therefore, reduce the dosage slowly when baclofen oral solution is discontinued, unless the clinical situation justifies a rapid withdrawal. 5.2 Neonatal Withdrawal Symptoms Withdrawal symptoms in neonates whose mothers were treated with oral baclofen throughout pregnancy have been reported starting hours to days after delivery. The symptoms of withdrawal in these infants have included increased muscle tone, tremor, jitteriness, and seizure. If the potential benefit justifies the potential risk to the fetus and baclofen is continued during pregnancy, gradually reduce the dosage and discontinue baclofen before delivery. If slow withdrawal is not feasible, advise the parents or caregivers of the exposed neonate of the potential for neonatal withdrawal. 5.3 Drowsiness and Sedation Drowsiness and sedation have been reported in up to 63% of patients taking baclofen, the active ingredient in baclofen oral solution [see Adverse Reactions (6.1) ] . Patients should avoid operation of automobiles or other dangerous machinery and activities made hazardous by decreased alertness when starting baclofen or increasing the dose until they know how the drug affects them. Advise patients that the central nervous system depressant effects of baclofen may be additive to those of alcohol and other CNS depressants. 5.4 Poor Tolerability in Stroke Patients Baclofen should be used with caution in patients who have had a stroke. Baclofen has not significantly benefited patients with stroke. These patients have also shown poor tolerability to the drug. 5.5 Exacerbation of Psychotic Disorders, Schizophrenia, or Confusional States Baclofen should be used with caution in patients suffering from psychotic disorders, schizophrenia, or confusional states. If treated with baclofen, these patients should be kept under careful surveillance because exacerbations of these conditions have been observed with oral baclofen administration. 5.6 Exacerbation of Autonomic Dysreflexia Baclofen should be used with caution in patients with a history of autonomic dysreflexia. The presence of nociceptive stimuli or abrupt withdrawal of baclofen may cause an autonomic dysreflexic episode. 5.7 Exacerbation of Epilepsy Baclofen should be used with caution in patients with epilepsy. Deterioration in seizure control has been reported in patients taking baclofen. 5.8 Posture and Balance Effects Baclofen should be used with caution in patients where spasticity is utilized to sustain upright posture and balance in locomotion or whenever spasticity is utilized to obtain increased function. 5.9 Ovarian Cysts A dose-related increase in incidence of ovarian cysts was observed in female rats treated chronically with oral baclofen. Ovarian cysts have been found by palpation in about 4% of the multiple sclerosis patients who were treated with oral baclofen for up to one year. In most cases, these cysts disappeared spontaneously while patients continued to receive the drug. Ovarian cysts are estimated to occur spontaneously in approximately 1% to 5% of the normal female population.