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PREGNANCY There are no adequate and well-controlled studies in pregnant womenIn animal studiesbaclofen had adverse effects on embryofetal development when administered orally to pregnant ratsLIORESAL INTRATHECAL should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Intrathecal massCases of intrathecal mass at the tip of the implanted catheter have been reportedmost of them involving pharmacy compounded analgesic admixturesThe most frequent symptoms associated with intrathecal mass are1decreased therapeutic responseworsening spasticityreturn of spasticity when previously well controlledwithdrawal symptomspoor response to escalating dosesor frequent or large dosage increases2pain3neurological deficit/dysfunctionClinicians should monitor patients on intraspinal therapy carefully for any new neurological signs or symptomsIn patients with new neurological signs or symptoms suggestive of an intrathecal massconsider a neurosurgical consultationsince many of the symptoms of inflammatory mass are not unlike the symptoms experienced by patients with severe spasticity from their diseaseIn some casesperformance of an imaging procedure may be appropriate to confirm or rule-out the diagnosis of an intrathecal mass.

Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion systemrefill scheduling and proceduresand pump alarmsPatients and caregivers should be advised of the importance of keeping scheduled refill visits and should be educated on the early symptoms of baclofen withdrawal.

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