VERY IMPORTANT ANNOUNCEMENT

[Guest guest]

Hi, Please read all of this in it's entirly, VERY IMPORTANT

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

Best regards,

" tenacity's man "

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