FDA MedWatch - July 2011 Safety Labeling Changes: 32 products with changes to Boxed Warning, Warnings, Contraindications, Precautions, Adverse Reactions

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> [MedWatch logo][MedWatch - The FDA Safety Information and Adverse Event

> Reporting Program]

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> The MedWatch July 2011 Safety Labeling Changes posting includes 32

> products with safety labeling changes to the following sections: BOXED

> WARNINGS, 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/ucm266122.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.

>

> The following drugs had modifications to the BOXED WARNINGS,

> CONTRAINDICATIONS and WARNINGS sections:

>

> Epogen/Procrit (epoetin alfa) and Aranesp (darbepoetin alfa)

> Dostinex (cabergoline) Tablets

> Nitrostat (nitroglycerin, USP) Sublingual Tablets

> Paxil (paroxetine HCl) tablets, oral solution and Paxil CR tablets

> Ranexa (Ranolazine) Extended-Release Tablets

> Rotavirus Vaccine, Live, Oral, Pentavalent (RotaTeq)

> Arava (leflunomide) Tablets

> Bentyl (dicyclomine hydrochloride, USP) Capsules/Tablets, Oral Syrup,

> Injection

> Chantix (varenicline) Tablets

> Flomax (tamsulosin hydrochloride) Capsules

> Gilenya (fingolimod) capsules 0.5 mg

> Kenalog-10 (triamcinolone acetonide) Injection, Kenalog-40

> (triamcinolone acetonide) Injection

> Micardis (telmisartan) Tablets

> Prograf (tacrolimus) Capsules, Injection

> Seroquel (quetiapine fumarate) Tablets, Seroquel (quetiapine fumarate) XR

> Tev-Tropin (somatropin [rDNA origin]) for injection

> Truvada (emtricitabine/tenofovir disoproxil fumarate) tablets

> Zegerid OTC (omeprazole 20mg and sodium bicarbonate 1100 mg) capsules

>

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