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The MedWatch May 2014 Safety Labeling Changes posting includes 37 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT.
The "Summary Page" provides a listing of product names and safety labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm400227.htm
The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS and PRECAUTIONS sections:
Accupril (quinapril)
Accuretic (quinapril HCl/hydrochlorothiazide)
Avandia (rosiglitazone maleate) tablets
Avandaryl (rosiglitazone maleate and glimepiride)
Avandamet (rosiglitazone maleate and metformin hydrochloride)
Edurant (rilpivirine)
Jentadueto (linagliptin and metformin hydrochloride)
Soriatane (acitretin)
Tradjenta (linagliptin)
Apidra (insulin glulisine [rDNA origin])
Altace (ramipril)
Aromasin (exemestane)
Azilect (rasagiline mesylate)
Bydureon (exenatide extended-release)
Gemzar (gemcitabine)
Lunesta (eszopiclone)
Sustiva (efavirenz)
Temodar (temozolomide)
Temodar (temozolomide)
Adempas (riociguat)
Aloxi (palonosetron hydrochloride)
Avalide (irbesartan/hydrochlorothiazide)
Avapro (irbesartan)
Cleocin HCl (clindamycin hydrochloride)
Cleocin Phosphate (clindamycin phosphate)
Colestid (colestipol HCl)
Humira (adalimumab)
Invokana (canagliflozin)
Tivicay (dolutegravir)
Xalkori (crizotinib)
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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