Safety Information > December 2012

Safety Information > December 2012

December 2012

Drug Safety Labeling Changes

The summary view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. The “quick view” table below provides the drug name and sections modified. Click on the drug name to go to the detailed view. The detailed view includes sections and subsections modified, a description of new or modified safety information in the BOXED WARNING, CONTRAINDICATIONS, or WARNINGS sections, and a link to the revised prescribing information. Key to Label Section Acronyms: BW=BOXED WARNING, C=CONTRAINDICATIONS, W=WARNINGS, P=PRECAUTIONS AR=ADVERSE REACTIONS, PPI/MG=PATIENT PACKAGE INSERT/MEDICATION GUIDE
DRUG NAME SECTIONS MODIFIED (Click on drug name to go to detailed view) BW C W P AR PPI/MG Incivek (Telaprevir) Film Coated Tablets1 X X X X   PCI (Click on drug name to go to detailed view) BW C W P AR PPI/MG Celexa (Citalopram Hydrobromide) Tablets and Oral Solution2 (Serotonin Toxicity associated with co-administration with Linezolid and Methylene Blue)   X  X        Effexor (Venlafaxine Hydrochloride) Tablets3 (Serotonin Toxicity associated with co-administration with Linezolid and Methylene Blue)   X  X      MG Effexor XR (Venlafaxine Hydrochloride) Extended-release Capsules4 (Serotonin Toxicity associated with co-administration with Linezolid and Methylene Blue)   X  X       MG Lexapro ( Escitalopram Oxalate) Tablets and Oral Solution5 (Serotonin Toxicity associated with co-administration with Linezolid and Methylene Blue)   X X  X     Omontys (Peginesatide) Injection6   X X  X     Paxil (Paroxetine Hydrochloride) Tablets and Oral Suspension7 (Serotonin Toxicity associated with co-administration with Linezolid and Methylene Blue)   X X  X     Pexeva (Paroxetine Mesylate) Tablets8 (Serotonin Toxicity associated with co-administration with Linezolid and Methylene Blue)   X X  X     Pradaxa (Dabigatran Etexilate)9   X X   X    MG  Pristiq (Desvenlafaxine) Extended-Release Tablet10 (Serotonin Toxicity associated with co-administration with Linezolid and Methylene Blue)   X X  X   PCI  Surmontil (Trimipramine Maleate) Capsules11   X X   X      Venlafaxine Extended Release Tablets12   X X  X     Viibryd (Vilazodone HCL) Tablets13 (Serotonin Toxicity associated with co-administration with Linezolid and Methylene Blue)   X X  X     Xyrem (Sodium Oxybate) Oral Solution14   X       MG Zoloft (Sertraline Hydrochloride) Tablets and Oral Concentrate15 (Serotonin Toxicity associated with co-administration with Linezolid and Methylene Blue)   X X       Zytiga (Abiraterone Acetate) Tablets16   X  X   X      (Click on drug name to go to detailed view) BW C W P AR PPI/MG Altabax (Retapamulin) Ointment17     X  X  X    Antara (Fenofibric Acid) Capsules18     X  X  X    Chantix (Varenicline) Tablets19     X  X    PCI  Edurant (Rilpivirine) Tablets20     X X      Fibricor (Fenofibric Acid) Tablets21     X X  X    Horizant (Gabapentin Enacarbil) Extended-Release Tablets22     X  X      Omeprazole, Sodium Bicarbonate and Magnesium Hydroxide Tablets23     X X      Sabril (Vigabatrin) Tablets24     X  X      Tamiflu (Oseltamivir Phosphate) Capsules and Oral Suspension25     X  X      (Click on drug name to go to detailed view) BW C W P AR PPI/MG Azulfidine (Sulfasalazine) Tablets, USP26       X     Azulfidine EN-Tabs (Sulfasalazine Delayed Release) Tablets, USP27       X     Benicar (Olmesartan Medoxomil) Tablets28       X     Benicar HCT (Olmesartan Medoxomil and Hydrochlorothiazide) Tablets29       X     Lopressor (Metoprolol Tartrate) Tablets and Injection30       X     (Click on drug name to go to detailed view) BW C W P AR PPI/MG Betaseron (Interferon Beta-1b) For Injection31         X   Enbrel (Etanercept) Injection32         X   Ionamin (Phentermine Resin) Capsules33         X   Nizoral (Ketoconazole) 2% Shampoo34         X   Restasis (Cyclosporine Ophthalmic Emulsion)35         X   Savella (Milnacipran HCL) Tablets36         X   Soliris (Eculizumab) Concentrated Solution For Intravenous Infusion37         X   Sylatron (Peginterferon Alfa-2b)38         X   Tasigna (Nilotinib) Capsules39         X   Tegretol (Carbamazepine USP) Chewable Tablets, Tablets, Suspension40         X   Victoza (Liraglutide [rDNA origin]) Injection41         X   (Click on drug name to go to detailed view) BW C W P AR PPI/MG Rapamune (Sirolimus) Oral Solution and Tablets42           MG