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U.S. Department of Health and Human Services

Safety

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Lioresal Intrathecal (baclofen injection)

Audience: Neurologists, Neurosurgeons, and other healthcare professionals

Medtronic and FDA added a BOXED WARNING and strengthened the WARNINGS sections of the prescribing information of Lioresal Intrathecal, indicated for use in the management of severe spasticity of cerebral and spinal origin. The warnings inform healthcare professionals about rare cases of intrathecal baclofen withdrawal that can lead to life threatening sequelae and/or death in patients who abruptly discontinue therapy.

[April 2002 - Letter - Medtronic]