Drug Safety Labeling Changes - December 2013

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December 2013

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
Iclusig (ponatinib) tabletsBoxed Warning-WarningsPrecautions----
Tysabri (natalizumab) InjectionBoxed Warning-WarningsPrecautions----
Hemabate (carboprost tromethamine) Sterile Solution Injection-Contraindications--Adverse Reactions---
Tikosyn (dofetilide) Capsules  -Contraindications------
Avastin (bevacizumab)--WarningsPrecautionsAdverse Reactions---
Benlysta (belimumab)--WarningsPrecautions----
Canasa (mesalamine) Rectal Suppository--WarningsPrecautions----
Concerta (methylphenidate HCl) Extended-Release Tablets --WarningsPrecautionsAdverse Reactions---
Daytrana (methylphenidate transdermal system) --WarningsPrecautionsAdverse Reactions---
Focalin (dexmethylphenidate) tablets and Focalin XR (Dexmethylphenidate Hydrochloride) extended-release tablets--WarningsPrecautionsAdverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Metadate CD (methylphenidate HCl) Extended-Release Capsules--WarningsPrecautionsAdverse Reactions---
Methylin (methylphenidate) Oral Solution and Chewable Tablets--WarningsPrecautionsAdverse Reactions---
Plavix (clopidogrel bisulfate) Tablets--WarningsPrecautionsAdverse Reactions---
Quillivant XR (methylphenidate) extended-release oral suspension --WarningsPrecautionsAdverse Reactions---
Ranexa (ranolazine) extended-release Tablets--WarningsPrecautionsAdverse Reactions---
Ritalin (methylphenidate hydrochloride) Tablets, Ritalin SR (Sustained-Release Tablets, and Ritalin LA Extended-Release Capsules --WarningsPrecautionsAdverse Reactions---
Taxotere (docetaxel) Injection Concentrate--WarningsPrecautionsAdverse Reactions---
Yervoy (ipilimumab)--WarningsPrecautions----
Brilinta (ticagrelor) Tablets----Adverse Reactions---
Tafinlar (dabrafenib) Capsules----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Adderall XR (mixed amphetamine salts) capsules----Adverse Reactions---
Amyvid (Florbetapir F 18 Injection)----Adverse Reactions---
Caverject Impulse Dual Chamber System (alprostadil for injection) ----Adverse Reactions---
Desoxyn (methamphetamine hydrochloride) tablets ----Adverse Reactions---
Dexedrine (dextroamphetamine sulfate) Spansule sustained release capsules----Adverse Reactions---
Lamictal (lamotrigine) tablets, chewable dispersible tablets----Adverse Reactions---
Lamictal ODT (lamotrigine) orally disintegrating tablets----Adverse Reactions---
Lamictal XR (lamotrigine) extended-release tablets----Adverse Reactions---
Lialda (mesalamine) Delayed-Release Tablets----Adverse Reactions---
Metastron (Strontium-89 Chloride) Injection----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
MoviPrep (PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution)----Adverse Reactions---
Pentasa (mesalamine) Controlled-Release Capsules----Adverse Reactions---
Pradaxa (dabigatran etexilate mesylate) Capsules----Adverse Reactions---
Protonix (pantoprazole sodium) for Delayed-Release Suspension, and Delayed-Release Oral Tablets----Adverse Reactions---
Protonix I.V. (pantoprazole sodium) for Injection----Adverse Reactions---
Singulair (montelukast sodium) Tablets, Chewable Tablets, and Oral Granules----Adverse Reactions---
Somavert (pegvisomant) injection----Adverse Reactions---
Zofran (ondansetron hydrochloride) Tablets, Oral Solution, Injection----Adverse Reactions---
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