November FDA Safety Information and Adverse Event Reporting

Drug Safety Labeling Changes

November 2011

 

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
Cerebyx (fosphenytoin sodium) Injection X X X X
Dilantin (phenytoin sodium, USP) Injection
X
X X X X
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Dilantin (phenytoin) Oral Suspension X X X X
Kombiglyze XR (saxagliptin/metformin hydrochloride extended-release) Tablets X X X X PCI
Mytelase (ambenonium chloride) Tablets X X X
Onglyza (saxagliptin) Tablets X X X X PCI
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Amturnide (aliskiren/amlodipine/hydrochlorothiazide) Tablets*Amlodipine/Simvsatin Interaction X X
Combivir (lamivudine/zidovudine) Tablets*Immune Reconstitution Syndrome  X X
Emtriva (emtricitabine) Capsules and Oral Solution*Immune Reconstitution Syndrome  X X
Epivir (lamivudine) Tablets and Oral Solution*Immune Reconstitution Syndrome X X
Epzicom (abacavir sulfate and lamivudine) Tablets*Immune Reconstitution Syndrome X X
Isentress (raltegravir potassium) Tablets X X X
Lioresal Intrathecal (baclofen injection) X X
Methotrexate Sodium for Injection X
Retrovir (zidovudine) IV Infusion, Capsules, Tablets, and Syrup*Immune Reconstitution Syndrome X X
Tekamlo (aliskiren/amlodipine) Tablets*Amlodipine/Simvsatin Interaction X X
Toviaz (fesoterodine fumarate) Extended Release Tablets X X
Tribenzor (olmesartan medoxomil, amlodipine, hydrochlorothiazide) Tablets*Amlodipine/Simvsatin Interaction X X
Trizivir (abacavir sulfate, lamivudine, and zidovudine) Tablets*Immune Reconstitution Syndrome X X
Twynsta (telmisartan/amlodipine)*Amlodipine/Simvsatin Interaction X X
VFEND (voriconazole) Tablets, I.V. for Infusion and Oral Suspension X X X
Videx (didanosine) Pediatric Powder Oral Solution*Immune Reconstitution Syndrome X X
Videx EC (didanosine, USP) Capsules*Immune Reconstitution Syndrome X X
Vimovo (naproxen/esomeprazole magnesium) Tablets X X X
Viread (tenofovir disoproxil fumarate) Tablets*Immune Reconstitution Syndrome X X
Zerit (stavudine) Capsules and Oral Solution*Immune Reconstitution Syndrome X X
Ziagen (abacavir sulfate) Tablets and Oral Solution*Immune Reconstitution Syndrome X X
Zyflo CR (zileuton) Extended Release Tablets X X
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Agrylin (anagrelide hydrochloride) Capsule X
Amoxil (amoxicillin) Chewable Tablets, Tablets and Oral Suspension X
Calan (verapamil hydrochloride) Intravenous Injection and Calan (verapamil hydrochloride) Intravenous Injection Syringe*Verapamil/HMG-CoA Reductase Inhibitors Interaction X
Cordarone (amiodarone HCl) Tablets X
Covera HS (verapamil hydrochloride) Extended Release Tablets*Verapamil/HMG-CoA Reductase Inhibitors Interaction X
Cozaar (losartan) Tablets X PPI
Hyzaar (losartan/hydrochlorothiazide) Tablets X PPI
Prinivil (lisinopril) Tablets X PPI
Prinzide (lisinopril/hydrochlorothiazide) Tablets X PPI
Protopic (tacrolimus) Ointment X X
Tarka (trandolapril/verapamil hydrochloride) Tablets*Verapamil/HMG-CoA Reductase Inhibitors Interaction X
Treximet (sumatriptan/naproxen) Tablets X
Verelan PM (verapamil hydrochloride) Extended-Release Capsules
Verelan (verapamil hydrochloride) Sustained-Release Capsules
*Verapamil/HMG-CoA Reductase Inhibitors Interaction
X
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
Lamisil (terbinafine hydrochloride) Tablets and Oral Granules X PCI
Tasigna (nilotinib) Capsules X
Velcade (bortezomib) for Injection
X
Viramune (nevirapine) Tablets, Oral Suspension and Virammune XR Extended-Release Tablets X
(Click on drug name to go to detailed view)

BW

C

W

P

AR

PPI/MG
AndroGel (testosterone gel) MG
Lamictal (lamotrigine) Tablets, Chewable Dispersible Tablets, Orally Disintegrating Tablets, and Lamictal XR (lamotrigine) Extended-Release Tablets MG
Testim (testosterone gel) MG

For Additional Safety Information go to:

PG

Author: H. Sandra Chevalier-Batik

I started the Inconvenient Woman Blog in 2007, and am the product of a long line of inconvenient women. The matriarchal line is French-Canadian, Roman Catholic, with a very feisty Irish great-grandmother thrown in for sheer bloody mindedness. I am a research analyst and author who has made her living studying technical data, and developing articles, training materials, books and web content. Tracking through statistical data, and oblique cross-references to find the relevant connections that identifies a problem, or explains a path of action, is my passion. I love clearly delineating the magic questions of knowledge: Who, What, Why, When, Where and for How Much, Paid to Whom. My life lessons: listen carefully, question with boldness, and personally verify the answers. I look at America through the appreciative eyes of an immigrant, and an amateur historian; the popular and political culture is a ceaseless fascination. I have no impressive initials after my name. I’m merely an observer and a chronicler, an inconvenient woman who asks questions, and sometimes encourages others to look at things differently.