April 2010 Drug Safety Labeling Changes: 44 Medical Product Labels with changes to Boxed Warning, Warnings, Contraindications, Precautions, Adverse Reactions

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The MedWatch March 2010 Drug Safety Labeling Changes posting includes 44

products with safety labeling changes to the following sections: BOXED WARNING,

CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE

INSERT, and MEDICATION GUIDE.

The " Summary Page " provides a listing of drug names and safety labeling sections

revised:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm209165.htm

Clicking on a drug product name in the Summary View will take you to the

" detailed view " page, which identifies safety labeling sections and subsections

revised, along with a brief summary of new or modified safety information to the

BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections.

The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS,

and WARNINGS sections:

Propylthiouracil tablets

Aptivus (tipranavir)

Crixivan (indinavir sulfate)

Invirase (saquinavir mesylate)

Kaletra (lopinavir/ritonavir)

Lexiva (fosamprenavir calcium)

Prezista (darunavir)

Reyataz (atazanavir)

Viracept (nelfinavir mesylate)

Acephen (acetaminophen)

FeverAll (acetaminophen)

Ortho Evra (norelgestromin/ethinyl estradiol)

Rapamune (sirolimus)

Sandimmune (cyclosporine)

Tarceva (erlotinib)

Tisseel (Fibrin Sealant)

Uroxatral (alfuzosin HCl)

Valtrex (valacyclovir hydrochloride)

Ventavis (iloprost)

Vytorin (ezetimibe/simvastatin)

Yasmin (drospirenone 3 mg/ethinyl estradiol 0.03 mg)

Yaz (drospirenone 3 mg/ethinyl estradiol 0.02 mg)

Zocor (simvastatin)

Zonegran (zonisamide)

Zyprexa Relprevv (olanzapine)

You are encouraged to report all serious adverse events and product quality

problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

This service is provided to you at no charge by U.S. Food & Drug Administration

(FDA).

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