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Cephalon issues new Provigil warnings

I'm not totally sure what the existing warnings were about Provigil, but in case you're taking it, you might be curious about some new warnings that Cephalon apparently issued recently:

Provigil, a prescription stay-awake drug, is getting new warnings about the risk of life-threatening rash, other serious hypersensitivity reactions, and psychiatric symptoms....

At least one person died of multi-organ failure shortly after starting Provigil, and there have been "rare" cases of serious or life-threatening rash in patients taking Provigil, states the drug's maker, Cephalon Inc....

Psychiatric symptoms including anxiety, mania, hallucinations, and suicidal thinking have also been reported in patients taking Provigil.

Just in case you're totally curious, the Provigil home page offers this warning right smack dab front and center (looks like it's been updated re this rash business):

PROVIGIL may cause you to have a serious rash or a serious allergic reaction that may result in hospitalization or be life-threatening. If you develop a rash, hives, sores, swelling, or trouble swallowing or breathing, stop taking PROVIGIL and call your doctor right away.

PROVIGIL is not approved for use in children.

If you experience chest pain, depression, anxiety, hallucinations, psychosis, mania, thoughts of suicide or other mental problems, stop taking PROVIGIL and call your doctor right away.

PROVIGIL does not replace sleep and may not stop your ES completely. Do not drive or do other dangerous activities until you know how PROVIGIL affects you. Avoid drinking alcohol while taking PROVIGIL.

PROVIGIL has the potential to be abused or lead to dependence. Please use only as directed.

Women who use hormonal birth control may have a higher chance for getting pregnant, while taking PROVIGIL, and for one month after stopping. Talk to your doctor about other birth control methods while taking PROVIGIL.

Common side effects of PROVIGIL are headache, nausea, nervousness, stuffy nose, diarrhea, back pain, anxiety, trouble sleeping, dizziness, and upset stomach.

So yeah. In case you were curious.

Posted By Scotto at 2007-12-21 00:11:06 permalink | comments
Tags: provigil modafinil
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