November 2011
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
BW
C
W
P
AR
PPI/MGCerebyx (fosphenytoin sodium) InjectionXXXX Dilantin (phenytoin sodium, USP) InjectionBW
C
W
P
AR
PPI/MGDilantin (phenytoin) Oral Suspension XXXX Kombiglyze XR (saxagliptin/metformin hydrochloride extended-release) Tablets XX X X PCI Mytelase (ambenonium chloride) Tablets X XX Onglyza (saxagliptin) Tablets XXXXPCI(Click on drug name to go to detailed view)BW
C
W
P
AR
PPI/MGAmturnide (aliskiren/amlodipine/hydrochlorothiazide) Tablets
*Amlodipine/Simvsatin Interaction
XXCombivir (lamivudine/zidovudine) Tablets
*Immune Reconstitution Syndrome
XXEmtriva (emtricitabine) Capsules and Oral Solution
*Immune Reconstitution Syndrome
XXEpivir (lamivudine) Tablets and Oral Solution
*Immune Reconstitution Syndrome
XXEpzicom (abacavir sulfate and lamivudine) Tablets
*Immune Reconstitution Syndrome
XX Isentress (raltegravir potassium) Tablets XXX Lioresal Intrathecal (baclofen injection) XX Methotrexate Sodium for Injection XRetrovir (zidovudine) IV Infusion, Capsules, Tablets, and Syrup
*Immune Reconstitution Syndrome
XXTekamlo (aliskiren/amlodipine) Tablets
*Amlodipine/Simvsatin Interaction
XX Toviaz (fesoterodine fumarate) Extended Release Tablets XXTribenzor (olmesartan medoxomil, amlodipine, hydrochlorothiazide) Tablets
*Amlodipine/Simvsatin Interaction
XXTrizivir (abacavir sulfate, lamivudine, and zidovudine) Tablets
*Immune Reconstitution Syndrome
XXTwynsta (telmisartan/amlodipine)
*Amlodipine/Simvsatin Interaction
XX VFEND (voriconazole) Tablets, I.V. for Infusion and Oral Suspension XXXVidex (didanosine) Pediatric Powder Oral Solution
*Immune Reconstitution Syndrome
XXVidex EC (didanosine, USP) Capsules
*Immune Reconstitution Syndrome
XX Vimovo (naproxen/esomeprazole magnesium) Tablets XXXViread (tenofovir disoproxil fumarate) Tablets
*Immune Reconstitution Syndrome
XXZerit (stavudine) Capsules and Oral Solution
*Immune Reconstitution Syndrome
XXZiagen (abacavir sulfate) Tablets and Oral Solution
*Immune Reconstitution Syndrome
XX Zyflo CR (zileuton) Extended Release Tablets XX (Click on drug name to go to detailed view)BW
C
W
P
AR
PPI/MGAgrylin (anagrelide hydrochloride) Capsule X Amoxil (amoxicillin) Chewable Tablets, Tablets and Oral Suspension X*Verapamil/HMG-CoA Reductase Inhibitors Interaction
X Cordarone (amiodarone HCl) Tablets XCovera 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 XXTarka (trandolapril/verapamil hydrochloride) Tablets
*Verapamil/HMG-CoA Reductase Inhibitors Interaction
X Treximet (sumatriptan/naproxen) Tablets X*Verapamil/HMG-CoA Reductase Inhibitors Interaction
X (Click on drug name to go to detailed view)BW
C
W
P
AR
PPI/MGLamisil (terbinafine hydrochloride) Tablets and Oral Granules XPCITasigna (nilotinib) CapsulesX Velcade (bortezomib) for Injection
BW
C
W
P
AR
PPI/MGAndroGel (testosterone gel) MGLamictal (lamotrigine) Tablets, Chewable Dispersible Tablets, Orally Disintegrating Tablets, and Lamictal XR (lamotrigine) Extended-Release Tablets MGTestim (testosterone gel)MG