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Summary View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- September 2005

 

The summary view includes drug products with safety labeling changes to the CONTRAINDICATIONS, BOXED WARNING, WARNINGS, PRECAUTIONS, or ADVERSE REACTIONS 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 Contraindications or Warnings sections and a link to the revised prescribing information.

Key: C=CONTRAINDICATIONS, BW=BOXED WARNING, W=WARNINGS, P=PRECAUTIONS, AR=ADVERSE REACTIONS

 

DRUG NAME

SECTIONS MODIFIED

(Click on drug name to go to detailed view)

C

BW

W

P

AR

Invirase (saquinavir mesylate) Capsules and Tablets X    X X X
ParaGard T 380A Intrauterine Copper Contraceptive X    X X X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Zevalin (ibritumomab tiuxetan)  

X

X   X

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Erbitux (cetuximab) for Intravenous Use     X X X
Elcon (mometasone furoate) Lotion, 0.1%     X    
Hep-Lock  U/P Preservative-Free (Heparin Lock Flush Solution, USP)     X X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR
Actiq (oral transmucosal fentanyl citrate)       X  
Actonel (risedronate sodium tablets)       X X
Arimidex (anastrozole) Tablets       X X
Cordarone (amiodarone hydrochloride) Intravenous       X X

Coumadin Tablets (warfarin sodium tablets, USP) Crystalline 
Coumadin for Injection (warfarin sodium for injection, USP)

      X  
Emtriva (emtricitabine) Capsules and Oral Solution       X X
Minocin (minocycline for injection) Intravenous       X  
Minocin (minocycline hydrochloride) Oral Suspension        X  
Minocin (minocycline hydrochloride) Pellet-Filled Capsules       X  
NovoLog (insulin aspart [rDNA origin] injection)       X  
Remicade (infiximab) for IV Injection       X X
Sandostatin (octreotide acetate) Injection       X X
Viracept (nelfinavir mesylate) Tablets and Oral Powder       X  
Zemplar (paricalcitol) Injection       X X
Zosyn (piperacillin and tazobactam for injection)        X  

(Click on drug name to go to detailed view)

C 
BW
W
P
AR

Amaryl (glimepiride tablets) Tablets

        X

Angiomax (bivalirudin) for Injection

        X

Argatroban Injection

        X

Flovent Diskus (fluticasone propionate inhalation powder)

        X

Lipitor (atorvastatin calcium) Tablets

        X

Lupron Injection (leuprolide acetate)

        X

Lupron Depot 3.75 mg (leuprolide acetate for depot suspension)

        X

Lupron Depot 7.5 mg (leuprolide acetate for depot suspension)

        X

Lupron Depot - 3 Month 11.25 mg (leuprolide acetate for depot suspension)

        X

Lupron Depot - 4 Month 30 mg (leuprolide acetate for depot suspension)

        X

Micardis (telmisartan) Tablets

        X

Micardis HCT (telmisartan/hydrochlorothiazide) Tablets

        X

Norvasc (amlodipine besylate) Tablets

        X

Photofrin (porfimer sodium) for Injection

        X

Viadur  (leuprolide acetate implant)

        X

Xenical (orlistat) Capsules

        X