Safety Information > October Safety Labeling Changes

Safety Information > October Safety Labeling Changes

October 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 Anafranil (clomipramine) capsules   X  X        Avalide (irbesartan/hydrochlorothiazide) tablets   X    X      Combigan (brimonidine tartrate/timolol maleate) 0.2%/0.5% ophthalmic solution   X X X X    Cymbalta (duloxetine hydrochloride) capsules   X  X  X     Diovan (valsartan) and Diovan HCT (valsartan/hydrochlorothiazide) Tablets   X    X      Edarbi (azilsartan medoxomil) Tablets   X    X      Edarbyclor (azilsartan medoxomil/chlorthalidone) Tablets   X   X     Letairis (ambrisentan) tablets   X     X MG Lotrel (amlodipine besylate and benazepril hydrochloride) Tablets   X  X   X   X    Micardis (telmisartan) and Micardis HCT (telmisartan/hydrochlorothiazide) tablets   X    X      Pamelor (nortriptyline HCl) solution and capsules   X  X        Remeron and Remeron SolTab (mirtazapine) tablets and orally disintegrating tablets   X  X       MG  Tofranil-PM (imipramine pamoate) capsules   X  X        (Click on drug name to go to detailed view) BW C W P AR PPI/MG Aciphex (rabeprazole sodium) Delayed-Release Tablets *Increased risk of Clostridium Difficile Associated Diarrhea (CDAD)     X  X      Actemra (tocilizumab) injection for intravenous infusion     X  X      Advicor (niacin ER/lovastatin) Tablets *IMNM label change     X  X   X    Alimta (pemetrexed for injection) lyophilized powder, for solution, for intravenous use     X  X      Altoprev (lovastatin) Extended-Release Tablets *IMNM label change     X  X  X   Caduet (amlodipine/atorvastatin) Tablets *IMNM label change     X  X   X  PCI  Cimzia (certolizumab pegol) lyophilized powder or solution for subcutaneous use     X X     Clomid (clomiphene citrate) tablets     X X  X    Crestor (rosuvastatin calcium) Tablets *IMNM label change     X  X   X    Fenoglide (fenofibrate) tablets     X  X  X   Gelnique (oxybutynin chloride) 10% gel     X  X      Juvisync (sitagliptin/simvastatin) Tablets *IMNM label change     X  X  X   Lescol XL (fluvastatin sodium) Extended-Release Tablets *IMNM label change     X  X   X    Lipitor (atorvastatin calcium) Tablets *IMNM label change     X X X   Livalo (pitavastatin) Tablets *IMNM label change     X  X   X    Mevacor (lovastatin) Tablets *IMNM label change     X  X   X    Nexium I.V. (esomeprazole sodium) for Injection *Clopidogrel interaction     X X     Nexium (esomeprazole magnesium) Delayed-Release Capsules and Oral Suspension *Clopidogrel interaction     X X     Oxytrol (oxybutynin) transdermal system     X  X      Pravachol (pravastatin sodium) Tablets *IMNM label change     X  X   X    Prilosec (omeprazole) Delayed-Release Capsules and Oral Suspension *Clopidogrel interaction     X  X   X    Protonix (pantoprazole sodium) For Delayed-Release Oral Suspension and Delayed-Release Tablets *Increased risk of Clostridium Difficile Associated Diarrhea (CDAD)     X  X      Protonix I.V. (pantoprazole sodium) for injection, for intravenous use *Increased risk of Clostridium Difficile Associated Diarrhea (CDAD)     X  X      Simcor (Niacin ER/Simvastatin) Tablets *IMNM label change     X  X  X   Topamax (Topiramate) Tablets and Sprinkle capsules     X  X    MG/PCI  Tracleer (Bosentan) Tablets     X  X      Twynsta (Telmisartan/Amlodipine) Tablets     X  X      Vimovo (naproxen/esomeprazole magnesium) Delayed Release Tablets *Clopidogrel interaction     X  X       Vytorin (ezetimibe/simvastatin) Tablets *IMNM label change     X  X   X    Zocor (simvastatin) Tablets *IMNM label change     X  X   X    (Click on drug name to go to detailed view) BW C W P AR PPI/MG Antivert (mecilizine hydrochloride) tablet       X     Baraclude (entecavir) tablets and oral solution       X     Savella (milnacipran HCl) tablets       X     Sclerosol Intrapleural Aerosol (sterile talc) powder       X     Yervoy (Ipilimumab) Injection       X     (Click on drug name to go to detailed view) BW C W P AR PPI/MG Avastin (bevacizumab) solution for intravenous infusion         X   Caprelsa (vandetanib) Tablets         X   Janumet (sitagliptin/metformin hydrochloride) fixed-dose combination tablets         X   Janumet XR (sitagliptin/metformin hydrochloride extended-release) fixed-dose combination Tablets         X   Januvia (sitagliptin) tablets         X   Pamidronate Disodium Injection         X   Velcade (bortezomib) for Injection         X   Rituxan (rituximab) Injection         X   Zortress (everolimus) tablets         X   (Click on drug name to go to detailed view) BW C W P AR PPI/MG Ilaris (canakinumab)