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The MedWatch December 2015 Safety Labeling Changes posting includes 31 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/ucm480758.htm
The following drugs had modifications to the WARNINGS AND PRECAUTIONS sections:
Astagraf XL (tacrolimus extended-release capsules)
Avonex (interferon beta-1a)
Betaseron (interferon beta-1b)
Clolar (clofarabine) Injection
Dexilant (dexlansoprazole) Delayed-Release Capsules
Exparel (bupivacaine liposome) Injectable Suspension
Extavia (interferon beta-1b)
Farxiga (dapagliflozin) Tablets
Glyxambi (empagliflozin and linagliptin) Tablets
Iclusig (ponatinib) Tablets
Invirase (saquinavir mesylate) Capsules and Tablets
Invokamet (canagliflozin and metformin HCl) Tablets
Invokana (canagliflozin) Tablets
Jardiance (empagliflozin) Tablets
Ortho-Cept (desogestrel/ethinyl estradiol) Tablets
Oxtellar XR (oxcarbazepine) Extended-release Tablets
Plegridy (peginterferon beta-1a)
Prevacid (lansoprazole) Delayed-Release Capsules and Orally Disintegrating Tablets
Rebif (interferon beta-1a)
Synjardy (empagliflozin and metformin hydrochloride) Tablets
Xeljanz (tofacitinib) Tablets
Xigduo XR (dapagliflozin and metformin HCl extended release) Tablets
Xolair (omalizumab) Powder for Injection
Zosyn (piperacillin and tazobactam for injection)
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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