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.htm 

In 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 HCl 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 

Source: FDA


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