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The August 2008 posting includes 41 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and PATIENT PACKAGE INSERTS.
The "Summary Page" provides a listing of drug names and safety labeling sections revised:
http://www.fda.gov/medwatch/safety/2008/aug08_quickview.htm
The "Detailed View Page" identifies safety labeling sections and subsections revised along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections:
http://www.fda.gov/medwatch/safety/2008/aug08.htmIn August 2008, the following drugs had modifications to the BOXED WARNING and/or CONTRAINDICATIONS sections:
Abilify (aripiprazole) Tablets, Abilify Discmelt (aripiprazole) Orally Disintegrating Tablets, Abilify (aripiprazole) Oral Solution, and Abilify (aripiprazole) Injection For Intramuscular Use Only
Clozaril (clozapine HCl) Tablets
FazaClo (clozapine) Orally Disintegrating Tablets
Geodon (ziprasidone HCl) Capsules and Geodon (ziprasidone mesylate) for Injection - For IM Use Only
Haldol (haloperidol injection) For Immediate Release
Haldol Decanoate (haloperidol) For IM Injection Only
Invega (paliperidone) Extended-Release Tablets
Moban (molindone hydrochloride tablets, USP)
Navane (thiothixene capsules) and Navane (thiothixene hydrochloride concentrate)
Risperdal (risperidone) Tablets, Risperdal (risperidone) Oral Solution, and Risperdal M-Tab (risperidone) Orally Disintegrating Tablets
Risperdal Consta (risperidone) Long-Acting Injection
Seroquel (quetiapine fumarate) Tablets
Seroquel XR (quetiapine fumarate) Extended-Release Tablets
Symbyax (olanzapine and fluoxetine HCl capsules)
Viread (tenofovir disoproxil fumarate) Tablets
Zyprexa (olanzapine tablets), Zyprexa Zydis (olanzapine orally disintegrating tablets), and Zyprexa IntraMuscular (olanzapine for injection)
Metadate CD (methylphenidate HCl, USP) Extended-Release Capsules
Reyataz (atazanavir sulfate) Capsules
Rocephin (ceftriaxone sodium) For Injection
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