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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.

Special attention must be given to recognizing the signs and symptoms of overdosageespecially during the initial screening and dose-titration phase of treatmentbut also during re-introduction of LIORESAL INTRATHECAL after a period of interruption in therapy.

This is not a complete list of possible side effectsIf you notice other effects not listed abovecontact your doctor or pharmacist.

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