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FDA Labeling Changes

May 2011

Safety Labeling Changes

The summary view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. The “quick view” table below provides the drug name and sections modified. Click on the drug name to go to the detailed view. The detailed view includes sections and subsections modified, a description of new or modified safety information in the BOXED WARNING, CONTRAINDICATIONS, or WARNINGS sections, and a link to the revised prescribing information.

Key to Label Section Acronyms:

BW=BOXED WARNING, C=CONTRAINDICATIONS, W=WARNINGS, P=PRECAUTIONS, AR=ADVERSE REACTIONS, PPI/MG=PATIENT PACKAGE INSERT/MEDICATION GUIDE

DRUG NAME	SECTIONS MODIFIED
(Click on drug name to go to detailed view)	BW	C	W	P	AR	PPI/MG
Imuran (azathioprine) Tablets and Injection	X		X		X
(Click on drug name to go to detailed view)	BW	C	W	P	AR	PPI/MG
Biaxin Filmtab (clarithromycin tablets, USP) Biaxin XL Filmtab (clarithromycin extended-release tablets) Biaxin Granules (clarithromycin for oral suspension, USP)		X	X		X
(Click on drug name to go to detailed view)	BW	C	W	P	AR	PPI/MG
Aciphex (rabeprazole sodium) Delayed-Release Tablets * Proton Pump Inhibitors Class Label Change			X	X	X	X
Afinitor (everolimus) Tablets			X	X
Aldactazide (spironolactone/hydrochlorothiazide) Tablets			X
Avandia (rosiglitazone maleate) Avandamet (rosiglitazone maleate/metformin hydrochloride) Avandaryl (rosiglitazone maleate/glimepiride) Tablets			X	X
Benicar HCT (olmesartan medoxomil/hydrochlorothiazide) Tablets			X
Dexilant (dexlansoprazole) Delayed Release Capsules * Proton Pump Inhibitors Class Label Change			X	X	X	X
Genotropin (somatropin [rDNA origin] for Injection			X	X	X
Humalog (insulin lispro [rDNA origin]) Injection			X	X
Levatol (penbutolol sulfate) Tablets			X	X
Micardis HCT (telmisartan/hydrochlorothiazide) Tablets			X	X
Norditropin Cartridges (somatropin [rDNA origin] injection)			X	X	X
Omeprazole / Sodium Bicarbonate / Magnesium Hydroxide Tablets * Proton Pump Inhibitors Class Label Change			X	X	X	X
Purinethol (mercaptopurine) Tablets			X
Prevacid (Lansoprazole) Delayed-Release Capsules, Prevacid SoluTab Delayed-Release Orally Disintegrating Tablets * Proton Pump Inhibitors Class Label Change			X	X	X	X
Prilosec (omeprazole) Delayed Release Capsules and Prilosec For Delayed Release Oral Suspension * Proton Pump Inhibitors Class Label Change			X	X	X	X
Proton Pump Inhibitors * Proton Pump Inhibitors Class Label Change			X	X	X	X
Protonix (pantoprazole sodium) For Delayed-Release Oral Suspension ; Delayed-Release Tablets, and I.V. for Injection * Proton Pump Inhibitors Class Label Change			X	X	X	X
Seroquel (quetiapine fumarate) Tablets Seroquel XR (quetiapine fumarate) Extended-Release			X	X
Sutent (sunitinib malate) Capsules			X	X	X
Teveten HCT (eprosartan mesylate/hydrochlorothiazide) Tablets			X	X
Uniretic (moexipril hydrochloride/hydrochlorothiazide)			X
Vimovo (naproxen/esomeprazole magnesium) Tablets * Proton Pump Inhibitors Class Label Change			X	X	X	X
Zegerid (omeprazole/sodium bicarbonate) Capsules and Powder for Oral Suspension * Proton Pump Inhibitors Class Label Change			X	X	X	X
Ziac (bisoprolol fumarate/hydrochlorothiazide) Tablets			X
(Click on drug name to go to detailed view)	BW	C	W	P	AR	PPI/MG
Azor (amlodipine and olmesartan medoxomil) Tablets				X	X
Capoten (captopril) Tablets				X
Exforge (amlodipine/valsartan) Tablets				X
Lexiva (fosamprenavir calcium) Tablets and Oral Suspension				X
Teveten (eprosartan mesylate) Tablets				X
Valturna (aliskiren/valsartan) Tablets				X
(Click on drug name to go to detailed view)	BW	C	W	P	AR	PPI/MG
Benicar (olmesartan medoxomil) Tablets					X
Vibramycin (doxycycline monohydrate) Oral Suspension Vibramycin (doxycycline hyclate) Capsules Vibramycin (doxycycline calcium oral suspension) Syrup Vibra-Tabs (doxycycline hyclate)					X
(Click on drug name to go to detailed view)	BW	C	W	P	AR	PPI/MG
Foradil Aerolizer (formoterol fumarate inhalation powder)						MG

Reviewed by:	Review Date:
Joseph V. Madia, MD	Friday, June 17, 2011

Source: FDA

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