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Summary View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- March 2006

 

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

 

DRUG NAME

SECTIONS MODIFIED
(Click on drug name to go to detailed view)

BW

C

W

P

AR

Advair Diskus (fluticasone propionate and salmeterol inhalation powder) X   X X X
Combunox (oxycodone HCl and ibuprofen) Tablets X   X X X  
Erbitux (cetuximab) X   X X X
Serevent Diskus (salmeterol xinafoate inhalation powder) X   X X X
(Click on drug name to go to detailed view)

BW

C

W

P

AR

Lotronex (alosetron hydrochloride) Tablets   X   X  

Macugen (pegaptanib sodium injection)

Macugen (pegaptanib sodium injection)

 

X

  X X

Vfend  I.V. (voriconazole) for Injection

Vfend (voriconazole) Tablets

Vfend (voriconazole) for Oral Suspension

  X   X  
Visicol (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) Tablets   X X X X
(Click on drug name to go to detailed view)

BW

C

W

P

AR

Lexiva (fosamprenavir calcium) Tablets      X X  
Nolvadex (tamoxifen citrate) Tablets     X X X
Ontak (denileukin diftitox)     X   X
Prograf (tacrolimus) Capsules and Injection     X X X
Relenza (zanamivir for inhalation)     X X X
Septocaine with epinephrine 1:100,000 

Septocaine with epinephrine 1:200,000

(articaine hydrochloride 4% (40 mg/mL) with epinephrine 1:100,000 or 1:200,000 injection)

    X   X
Taxotere (docetaxel) Injection Concentrate     X X X
Truvada (emtricitabine and tenofovir disoproxil fumarate) Tablets     X   X
Viread (tenofovir disoproxil fumarate) Tablets     X   X
Zyban (bupropion hydrochloride) Sustained-Release Tablets     X    
(Click on drug name to go to detailed view)

BW

C

W

P

AR

Avapro (irbesartan) Tablets       X  
Cardura XL (doxazosin mesylate extended release tablets)       X X
Cozaar (losartan potassium tablets)       X  
Detrol (tolterodine tartrate tablets)       X  
Fosrenol (lanthanum carbonate) Chewable Tablets       X  
Lamictal (lamotrigine) Tablets and Chewable Dispersible Tablets       X  

Lescol (fluvastatin sodium) Capsules

Lescol XL (fluvastatin sodium) Extended-Release Tablets

      X  
Naprosyn (naproxen tablets)

Naprosyn (naproxen suspension)

EC-Naprosyn (naproxen delayed-release tablets)

Anaprox/Anaprox DS (naproxen sodium tablets)

      X X

Neoral Soft Gelatin Capsules (cyclosporine capsules, USP) Modified

Neoral Oral Solution (cyclosporine oral solution, USP) Modified

      X  
Paxil (paroxetine hydrochloride) Tablets and Oral Suspension       X X
Paxil CR (paroxetine hydrochloride) Controlled-Release Tablets       X X
Phospholine Iodide (echothiophate iodide for ophthalmic solution)       X  

Sandimmune Soft Gelatin Capsules (cyclosporine capsules, USP)

Sandimmune Oral Solution (cyclosporine oral solution, USP)

Sandimmune Injection (cyclosporine injection, USP) for Infusion Only

      X  
Sustiva (efavirenz) Capsules and Tablets       X  
Thyro-Tabs (levothyroxine sodium tablets, USP)       X  
Uroxatral (alfuzosin HCl extended release tablets)       X X
Vanos (fluocinonide) Cream, 0.1%       X X
(Click on drug name to go to detailed view)

BW

C

W

P

AR

Aranesp (darbepoetin alfa) for Injection

        X

Atrovent HFA (ipratropium bromide HFA) Inhalation Aerosol

        X

Cialis (tadalafil) Tablets

        X

Ethyol (amifostine) for Injection

        X

Remodulin (treprostinil sodium) Injection

        X

Temodar (temozolomide) Capsules

        X

Vytorin (ezetimibe/simvastatin tablets)

        X

Zetia (ezetimibe) Tablets

        X