Drug Safety Labeling Changes - August 2008

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August 2008

This monthly summary of drug label changes provides a quick view of the sections that have changed. Click on a drug name to view the changes in more detail.

Key to Label Sections
BW - Boxed Warning C - Contraindications W - Warnings P - Precautions
AR - Adverse Reactions PPI - Patient Package Insert MG - Medication Guide PCI - Patient Counseling Information

Sections Modified
Drug Name BW C W P AR PPI MG PCI
Abilify (aripiprazole) TabletsBoxed Warning-Warnings-----
Abilify Discmelt (aripiprazole) Orally Disintegrating TabletsBoxed Warning-Warnings-----
Abilify (aripiprazole) Oral SolutionBoxed Warning-Warnings-----
Abilify (aripiprazole) Injection For Intramuscular Use OnlyBoxed Warning-Warnings-----
Clozaril (clozapine HCl) TabletsBoxed Warning-Warnings-----
Geodon (ziprasidone HCl) CapsulesBoxed Warning-Warnings-----
Geodon (ziprasidone mesylate) for Injection - For IM Use OnlyBoxed Warning-Warnings-----
Haldol (haloperidol injection) For Immediate ReleaseBoxed Warning-Warnings-----
Haldol Decanoate (haloperidol) For IM Injection OnlyBoxed Warning-Warnings-----
Invega (paliperidone) Extended-Release TabletsBoxed Warning-Warnings-----
Drug Name BW C W P AR PPI MG PCI
Moban (molindone hydrochloride tablets, USP)Boxed Warning-Warnings-----
Navane (thiothixene hydrochloride concentrate)Boxed Warning-Warnings-----
Navane (thiothixene capsules)Boxed Warning-Warnings-----
Risperdal (risperidone) TabletsBoxed Warning-Warnings-----
Risperdal (risperidone) Oral SolutionBoxed Warning-Warnings-----
Risperdal M-Tab (risperidone) Orally Disintegrating TabletsBoxed Warning-Warnings-----
Risperdal Consta (risperidone) Long-Acting InjectionBoxed Warning-Warnings-----
Seroquel (quetiapine fumarate) TabletsBoxed Warning-Warnings-----
Seroquel XR (quetiapine fumarate) Extended-Release TabletsBoxed Warning-Warnings-----
Symbyax (olanzapine and fluoxetine HCl capsules)Boxed Warning-Warnings-----
Drug Name BW C W P AR PPI MG PCI
Viread (tenofovir disoproxil fumarate) TabletsBoxed WarningContraindicationsWarningsPrecautionsAdverse ReactionsPatient Package Insert--
Zyprexa (olanzapine tablets)Boxed Warning-Warnings-----
Zyprexa Zydis (olanzapine orally disintegrating tablets)Boxed Warning-Warnings-----
Zyprexa IntraMuscular (olanzapine for injection)Boxed Warning-Warnings-----
Metadate CD (methylphenidate HCl, USP) Extended-Release Capsules-Contraindications-PrecautionsAdverse Reactions---
Reyataz (atazanavir sulfate) Capsules-Contraindications-Precautions-Patient Package Insert--
Rocephin (ceftriaxone sodium) For Injection-ContraindicationsWarningsPrecautionsAdverse Reactions---
Phosphocol P 32 (chromic phosphate P 32 suspension)--WarningsPrecautionsAdverse Reactions---
Retisert (fluocinolone acetonide intravitreal implant)--WarningsPrecautionsAdverse Reactions---
Sustiva (efavirenz) Capsules and Tablets--Warnings-Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Vidaza (azacitidine for injection) For SC or IV Use--WarningsPrecautionsAdverse Reactions---
Zemuron (rocuronium bromide) Injection Solution For Intravenous Use--WarningsPrecautions----
Corzide (nadolol and bendroflumethiazide tablets)---Precautions----
Glucophage (metformin hydrochloride tablets)---Precautions----
Glucophage XR (metformin hydrochloride extended-release tablets)---Precautions----
Kerlone (betaxolol hydrochloride tablets)---Precautions----
Metaglip (glipizide and metformin HCl) Tablets---Precautions----
Norvir (ritonavir capsules) Soft Gelatin---PrecautionsAdverse ReactionsPatient Package Insert--
Norvir (ritonavir oral solution)---PrecautionsAdverse ReactionsPatient Package Insert--
Precose (acarbose tablets)---Precautions----
Drug Name BW C W P AR PPI MG PCI
Cialis (tadalafil) Tablet, Film Coated----Adverse Reactions---
Femara (letrozole tablets)----Adverse Reactions---
Megace ES (megestrol acetate oral suspension)----Adverse Reactions---
Synagis (palivizumab) For Intramuscular Administration----Adverse Reactions---
Viagra (sildenafil citrate) Tablets----Adverse Reactions---
Zovirax (acyclovir) Capsules and Tablets----Adverse Reactions---
Zovirax (acyclovir) Suspension----Adverse Reactions---
Omnitrope Pen 10 (somatropin [rDNA origin] injection), For Subcutaneous Use-----Patient Package Insert--
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