Fw: MedWatch Alert (CORRECTED) - Lioresal Intrathecal (baclofen injec tion) Boxed Warning added

[Guest guest]

Here is a Correction I got in regards to that Email I sent eariler.

Me

mymocha@...

> MedWatch: The FDA Safety Information and Adverse Event Reporting Program

>

>

> 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.

>

> Read the MedWatch 2002 safety alert summary, including links to the " Dear

> Healthcare Professional " letter and the revised label, at:

>

> http://www.fda.gov/medwatch/SAFETY/2002/safety02.htm#baclof

>

>

> ----

>

> MedWatch is your Internet gateway for timely safety information on drugs

and

> other medical products regulated by the U.S. Food and Drug Administration.

> Visit the MedWatch web site regularly for the latest official safety

> information, at http://www.fda.gov/medwatch

>

>