Drug Safety Labeling Changes - May 2009

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May 2009

This monthly summary of drug label changes provides a quick view of the sections that have changed. Click on a drug name to view the changes in more detail.

Key to Label Sections
BW - Boxed Warning C - Contraindications W - Warnings P - Precautions
AR - Adverse Reactions PPI - Patient Package Insert MG - Medication Guide PCI - Patient Counseling Information

Sections Modified
Drug Name BW C W P AR PPI MG PCI
Advil--Warnings-----
Campath (alemtuzumab) Injection for intravenous use--WarningsPrecautionsAdverse Reactions---
Coly-Mycin M Parenteral (colistimethate for Injection, USP)--WarningsPrecautions----
Kerlone (betaxolol hydrochloride) 10 mg and 20 mg tablets--WarningsPrecautionsAdverse Reactions---
Letairis (ambrisentan) 5 and 10 mg Tablets--WarningsPrecautions----
Meridia (sibutramine hydrochloride monohydrate) 5, 10, and 15 mg Capsules--Warnings-Adverse Reactions---
Ancobon (flucytosine) 250 mg and 500 mg Capsules---PrecautionsAdverse Reactions---
Kepivance (palifermin)---Precautions----
Plavix (clopidogrel bisulfate) 75 mg tablets---Precautions----
Stromectol (ivermectin) 3 mg tablet---Precautions----
Drug Name BW C W P AR PPI MG PCI
Claforan Sterile (cefotaxime for injection, USP) and Injection (cefotaxime injection, USP)----Adverse Reactions---
Combivent Inhalation Aerosol (ipratropium bromide and albuterol sulfate) Inhalation Aerosol----Adverse Reactions---
Lotrisone (clotrimazole and betamethasone dipropionate) Cream and Lotion----Adverse ReactionsPatient Package Insert--
PegIntron (peginterferon alfa-2b) Injection, Powder for Solution for Subcutaneous Use----Adverse Reactions---
Uroxatral (alfuzosin HCl extended release tablets)----Adverse Reactions---
Vectibix (panitumumab)----Adverse Reactions---
Vyvanse (lisdexamfetamine dimesylate) 20mg, 30mg, 40mg, 50mg, 60mg, 70mg capsules----Adverse Reactions---
Femring (estradiol acetate vaginal ring)-----Patient Package Insert--
Prempro 0.3 mg/1.5 mg and 0.45 mg/1.5 mg (conjugated estrogens/medroxyprogesterone acetate tablets)-----Patient Package Insert--
Tyzeka (telbivudine) 600 mg tablet--------

Drug Safety Labeling Changes Archive

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