Drug Safety Labeling Changes - April 2010

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April 2010

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
Propylthiouracil tabletsBoxed WarningContraindicationsWarningsPrecautionsAdverse Reactions---
Aptivus (tipranavir) capsules-Contraindications------
Invirase (saquinavir mesylate) capsules and tablets-Contraindications-Precautions----
Kaletra (lopinavir/ritonavir) capsules, tablets, and oral solution-Contraindications-Precautions----
Reyataz (atazanavir) capsules-Contraindications-Precautions----
Viracept (nelfinavir mesylate) tablets and oral powder-Contraindications-Precautions----
Acephen (acetaminophen) rectal suppositories--Warnings-----
Artiss (Fibrin Sealant)--WarningsPrecautionsAdverse Reactions---
Evicel (Fibrin Sealant)--WarningsPrecautionsAdverse Reactions---
FeverAll (acetaminophen) rectal suppositories--Warnings-----
Drug Name BW C W P AR PPI MG PCI
Ortho Evra (norelgestromin/ethinyl estradiol) transdermal system--Warnings-----
Sandimmune (cyclosporine) soft gelatin capsules, injection, and oral solution--WarningsPrecautionsAdverse Reactions---
Tarceva (erlotinib) tablets--WarningsPrecautionsAdverse Reactions---
Tisseel (Fibrin Sealant)--WarningsPrecautionsAdverse Reactions---
Uroxatral (alfuzosin HCl) extended-release tablets--WarningsPrecautions----
Valtrex (valacyclovir hydrochloride) caplets--WarningsPrecautions----
Ventavis (iloprost) inhalation solution--WarningsPrecautionsAdverse Reactions---
Yasmin (drospirenone 3 mg/ethinyl estradiol 0.03 mg) tablets--Warnings-----
Yaz (drospirenone 3 mg/ethinyl estradiol 0.02 mg) tablets--Warnings-----
Ambien IR and Ambien CR (zolpidem tartrate)tablets---Precautions----
Drug Name BW C W P AR PPI MG PCI
Calan (verapamil hydrochloride) tablets---Precautions----
Covera HS (verapamil hydrochloride) extended release tablets---Precautions----
Flumadine (rimantadine hydrochloride) tablets---Precautions----
Lidoderm (lidocaine 5%) patch---Precautions----
Norvir (ritonavir) tablet for oral use and solution for oral use---Precautions----
Ritalin LA (methylphenidate hydrochloride) extended-release capsules---PrecautionsAdverse Reactions---
Verelan PM (verapamil hydrochloride) extended-release capsules---Precautions----
Allegra-D 24 hour (fexofenadine HCL 180mg/pseudoephedrinie HCL 240mg) extended release tablets----Adverse Reactions---
Leukeran (chlorambucil) tablets----Adverse Reactions---
Lupron and Lupron Depot (leuprolide acetate) injection----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Ondansetron injection, premix for intravenous use----Adverse Reactions---
Temodar (temozolomide) capsules and for injection----Adverse Reactions---
Folotyn (pralatrexate) injection-----Patient Package Insert--
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