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Hi,

  I heard a rumor that Baclofen had been taken off of the market. I did some
research, it hasn't been taken off the market BUT:

http://www.mageerehab.org/e3front.dll?durki=3782

Health Warning Alert for Individuals Using the Drug “Baclofen”
Philadelphia September 9, 2002—Magee Rehabilitation Hospital announced today
that it has learned of a serious shortage of the drug Baclofen (also known
by the trade name Lioresal). Baclofen is a drug taken orally in tablet form
by individuals with various neurologic injuries and diseases, including:
spinal cord injury, stroke, multiple sclerosis, and cerebral palsy.

Baclofen used in implanted pumps appears to be unaffected by this shortage.

The drug is used to alleviate symptoms of spasticity (involuntary muscle
contractions and spasms).

The shortage of the drug, according to its three generic manufacturers, is
due to a raw materials shortage. Future supplies may not be available until
January, 2003. Individuals may not be easily weaned off the drug, and if
Baclofen is suddenly unavailable to users, the consequences can range from
increased spasticity to delirium, seizures and even death.

Magee Rehabilitation Hospital advises individuals using oral Baclofen to
check with their pharmacy regarding its availability. Individuals unable to
obtain oral Baclofen should contact their prescribing physician on how to
proceed.


AND:

http://www.lexi.com/web/newdrugwarnings.jsp

Warning Concerning Abrupt Discontinuation of Lioresal® Intrathecal, 4/02

The Food and Drug Administration (FDA) has strengthened the labeling of
intrathecal baclofen (Lioresal® Intrathecal, Novartis) alerting prescribers
to new safety information. A black box warning has been added addressing the
potential for severe withdrawal reactions following abrupt discontinuation.
Symptoms of severe withdrawal reactions include altered mental status,
hyperpyrexia, rebound/exaggerated spasticity, muscle rigidity, and
rhabdomyolysis. Fatalities have been reported. Patients with communication
difficulties, a history of baclofen withdrawal,or injuries at the level of
T-6 or above may be at increased risk. Patients and caregivers should be
cautioned to keep refill appointments and to be alert to early symptoms of
withdrawal.

http://www.emedicine.com/recalls_and_alerts.htm

5/24/02
Abrupt Withdrawal of Baclofen (Lioresal) Intrathecal is Life-threatening
Prescribing information for baclofen (Lioresal) intrathecal injection now
includes a warning about rare cases of sequelae following abrupt
discontinuation of therapy that includes 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.

It is imperative for patients and healthcare providers to understand the
early symptoms of baclofen withdrawal and the importance of compliance with
scheduled refill visits. Carefully monitor patients with an increased risk
(eg, spinal cord injuries at T-6 or above, communication difficulties,
history of withdrawal symptoms from oral or intrathecal baclofen); however,
all patients receiving intrathecal baclofen therapy are potentially at risk
for withdrawal.

Early symptoms may include return of baseline spasticity, pruritus,
hypotension, and paresthesias. Some clinical characteristics of advanced
withdrawal may resemble autonomic dysreflexia, infection (sepsis), malignant
hyperthermia, neuroleptic-malignant syndrome, or other conditions associated
with a hypermetabolic state or widespread rhabdomyolysis.

Treat the withdrawal symptoms by restoring intrathecal baclofen infusion or
if restoration is delayed, treat with GABA agonist drugs (eg, baclofen PO/NG
plus benzodiazepines).

Find more information at FDA MedWatch.


Not good, you can only decrease this drug by 5 mg every 3 days until you are
off of it.  It has to be titrated down not abruptly stopped.

If you use this med, you need to call your doctor ASAP and see what he can
do.

Hugs,

Deborah




Hugs and Warm Fuzzies,
Deborah aka Tenacity

Personal website & photo's
http://pages.ivillage.com/tenacitywins/
http://community.webshots.com/user/tenacitywins


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