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The MedWatch September 2015 Safety Labeling Changes posting includes 48 products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE.
The "Summary Page" table provides a listing of product names and safety labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm465836.htm
The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS sections:
Accupril (quinapril hydrochloride) Tablets
Accuretic (quinapril hydrochloride/hydrochlorothiazide) Tablets
Altace (ramipril) Capsules
Avastin (bevacizumab)
Brilinta (ticagrelor) Tablets
Bydureon (exenatide extended-release) for Injectable Suspension
Cialis (tadalafil) Tablets
Clozaril (clozapine) Tablets
Combivir (lamivudine and zidovudine) Tablets
Doryx (doxycycline hyclate) Delayed-Release Capsules
Epzicom (abacavir and lamivudine) Tablets
Fazaclo (clozapine) Orally Disintegrating Tablets
Gazyva (obinutuzumab)
Humira (adalimumab) Solution
Invokamet (canagliflozin and metformin HCl) Tablets
Invokana (canagliflozin) Tablets
Levitra (vardenafil hydrochloride) Tablets
Myalept (metreleptin) for Injection
Neulasta (pegfilgrastim) Prefilled Syringe/On-body Injector
Neurontin (gabapentin) Capsules, Tablets, and Syrup
Nicorette (nicotine polacrilex) Gum
Nicorette (nicotine polacrilex) Large Lozenge
PegIntron (peginterferon alfa-2b) Injection, for Subcutaneous Use
Proglycem (diazoxide) Capsules and Oral Suspension
Sabril (vigabatrin) Tablet and Powder for Oral Solution
Sancuso (granisetron)
Staxyn (vardenafil hydrochloride) Orally Disintegrating Tablets
Stendra (avanafil) Tablets
Triumeq (abacavir sulfate, dolutegravir, and lamivudine) Tablets
Trizivir (abacavir, lamivudine, and zidovudine) Tablets
Velcade (bortezomib) for Injection
Versacloz (clozapine) Oral Suspension
Viagra (sildenafil citrate) Tablets
Votrient (pazopanib) Tablets
Xalkori (crizotinib)
Zestril (lisinopril) Tablets
Ziagen (abacavir) Tablets and Oral Solution
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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