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PostPosted: Wed Jan 09, 2008 10:40 pm 
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Posts: 6456
Location: Ottawa
http://www.accessdata.fda.gov/psn/trans ... ?show=71#1
Quote:
Cephalon has notified healthcare professionals about new safety information for Provigil (modafinil). Provigil is used to reduce excessive sleepiness in adult patients with narcolepsy and other sleep disorders. Provigil is not approved for any indication in children.

The revised labeling warns that Provigil can cause life-threatening skin reactions, including Stevens-Johnson Syndrome (SJS). Although benign rashes can also occur with this drug, the company says that it is not possible to reliably predict which rashes will be serious. Because of this, Provigil should ordinarily be stopped at the first sign of a rash, unless the rash clearly is not related to the drug.

The labeling also warns that Provigil can cause other serious hypersensitivity reactions. If a multi-organ hypersensitivity reaction is suspected, the drug should be discontinued. Patients should be told to stop taking the drug if they develop signs or symptoms suggesting angioedema or anaphylaxis.

Provigil can also cause psychiatric symptoms, including anxiety, mania, hallucinations and suicidal ideation. The company advises caution when the drug is given to patients with a history of psychosis, depression or mania. If psychiatric symptoms develop, consider discontinuing the drug.


Additional Information:

FDA MedWatch Safety Alert. Provigil (modafinil) Tablets. October 24, 2007.
http://www.fda.gov/medwatch/safety/2007 ... m#Provigil


Quote:
Modafinil is a white to off-white, crystalline powder that is practically insoluble in water and
cyclohexane. It is sparingly to slightly soluble in methanol and acetone. PROVIGIL tablets
contain 100 mg or 200 mg of modafinil and the following inactive ingredients: lactose,
microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, povidone, and
magnesium stearate.

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Daughter: asthma, allergies to egg, milk, peanuts, tree nuts, most legumes (not soy) & penicillin. Developing hayfever type allergies.
Husband: no allergies
Me: allergies to some tree that flowers in May
Cat: allergic to beef, pork and lamb


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PostPosted: Mon Jun 08, 2009 4:22 am 
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Joined: Mon May 18, 2009 11:10 am
Posts: 6
_Susan_ wrote:
http://www.accessdata.fda.gov/psn/transcript.cfm?show=71#1
Quote:
Cephalon has notified healthcare professionals about new safety information for Provigil (modafinil). Provigil is used to reduce excessive sleepiness in adult patients with narcolepsy and other sleep disorders. Provigil is not approved for any indication in children.

The revised labeling warns that Provigil can cause life-threatening skin reactions, including Stevens-Johnson Syndrome (SJS). Although benign rashes can also occur with this drug, the company says that it is not possible to reliably predict which rashes will be serious. Because of this, Provigil should ordinarily be stopped at the first sign of a rash, unless the rash clearly is not related to the drug.

The labeling also warns that Provigil can cause other serious hypersensitivity reactions. If a multi-organ hypersensitivity reaction is suspected, the drug should be discontinued. Patients should be told to stop taking the drug if they develop signs or symptoms suggesting angioedema or anaphylaxis.

Provigil can also cause psychiatric symptoms, including anxiety, mania, hallucinations and suicidal ideation. The company advises caution when the drug is given to patients with a history of psychosis, depression or mania. If psychiatric symptoms develop, consider discontinuing the drug.

Additional Information:

FDA MedWatch Safety Alert. Provigil (modafinil) Tablets. October 24, 2007.
http://www.fda.gov/medwatch/safety/2007 ... m#Provigil


Quote:
Modafinil is a white to off-white, crystalline powder that is practically insoluble in water and
cyclohexane. It is sparingly to slightly soluble in methanol and acetone. PROVIGIL tablets
contain 100 mg or 200 mg of modafinil and the following inactive ingredients: lactose,
microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, povidone, and
magnesium stearate.


Thanks for that information Susan. I think it is scary to hear what side effect medication that is readily available on the market can cause. If you google for it the sites you get have huge lists of the side effects of these drug on them.
I know a person who took provigil for some time but then stopped it because of the problems she was experiencing - probably better that way! :?


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