Drug Safety Labeling Changes - January 2008

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January 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
EstroGel 0.06% (estradiol gel)Boxed Warning-WarningsPrecautionsAdverse ReactionsPatient Package Insert--
Rituxan (rituximab) Injection For Intravenous UseBoxed Warning-WarningsPrecautionsAdverse Reactions---
Alesse 28 Tablets (levonorgestrel and ethinyl estradiol tablets)-ContraindicationsWarnings--Patient Package Insert--
Janumet (sitagliptin/metformin HCl) Tablets-ContraindicationsWarningsPrecautionsAdverse ReactionsPatient Package Insert--
Mycamine (micafungin sodium) For Injection-Contraindications-PrecautionsAdverse Reactions---
Omnitrope [somatropin (rDNA origin) injection] For Subcutaneous Use-ContraindicationsWarningsPrecautionsAdverse ReactionsPatient Package Insert--
Tysabri (natalizumab) Injection For Intravenous Use-ContraindicationsWarningsPrecautionsAdverse Reactions---
WelChol (colesevelam hydrochloride) Tablets-ContraindicationsWarningsPrecautionsAdverse Reactions---
Azactam (aztreonam for injection, USP)--WarningsPrecautions----
Azactam (aztreonam injection) in GALAXY Plastic Container (PL 2040) For Intravenous Use--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Cialis (tadalafil) Tablets--WarningsPrecautions-Patient Package Insert--
E.E.S. (erythromycin ethylsuccinate)--WarningsPrecautions----
Ery-Ped (erythromycin ethylsuccinate, USP)--WarningsPrecautions----
Humira (adalimumab) Injection, Solution For Subcutaneous Use--WarningsPrecautions----
Ortho Evra (norelgestromin/ethinyl estradiol transdermal system)--Warnings--Patient Package Insert--
PCE (erythromycin particles in tablets) Dispertab Tablets--WarningsPrecautions----
Rapamune (sirolimus) Oral Solution and Tablets--WarningsPrecautionsAdverse Reactions---
Byetta (exenatide) injection---Precautions-Patient Package Insert--
Cipro I.V. (ciprofloxacin) For Intravenous Infusion---PrecautionsAdverse Reactions---
Cipro (ciprofloxacin hydrochloride) Tablets---PrecautionsAdverse ReactionsPatient Package Insert--
Drug Name BW C W P AR PPI MG PCI
Cipro (ciprofloxacin) Oral Suspension---PrecautionsAdverse ReactionsPatient Package Insert--
Cipro XR (ciprofloxacin extended-release tablets)---PrecautionsAdverse ReactionsPatient Package Insert--
Flumadine (rimantadine) Tablets and Syrup---Precautions----
Inderide (propranolol hydrochloride [Inderal] and hydrochlorothiazide) Tablets---Precautions----
InnoPran XL (propranolol hydrochloride) Extended Release Capsules---Precautions----
Lopressor (metoprolol tartrate tablets, USP)---Precautions----
Lopressor (metoprolol tartrate injection, USP)---Precautions----
Lopressor HCT (metoprolol tartrate USP and hydrochlorothiazide USP) Tablets---Precautions----
Seroquel (quetiapine fumarate) Tablets---PrecautionsAdverse Reactions---
Sular (nisoldipine) Extended Release Tablets---PrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Tamiflu (oseltamivir phosphate) Capsules and For Oral Suspension---PrecautionsAdverse ReactionsPatient Package Insert--
Triglide (fenofibrate) Tablets---Precautions----
Celebrex (celecoxib) Capsules----Adverse Reactions---
Climara (estradiol transdermal system)----Adverse Reactions---
Lotrisone (clotrimazole and betamethasone dipropionate) Cream and Lotion----Adverse ReactionsPatient Package Insert--
Avandia (rosiglitazone maleate) Tablets-----Patient Package Insert--
Nexium (esomeprazole magnesium) Delayed-Release Capsules-----Patient Package Insert--
Tolectin DS (tolmetin sodium) Capsules--------
Tolectin 600 (tolmetin sodium) Tablets For Oral Administration--------
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