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The MedWatch November 2015 Safety Labeling Changes posting includes 19 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/ucm476260.htm
The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS sections:
0.9% Sodium Chloride Injection, USP in Mini-Bag & Viaflex Container
Aggrenox (aspirin/extended release dipyridamole) Capsules
Avagard Surgical and Healthcare Personnel Hand Antiseptic (chlorhexidine gluconate 1% solution and ethyl alcohol 61% w/w)
Cefepime for Injection, USP and Dextrose Injection
Harvoni (ledipasvir/sofosbuvir) Tablet
Kaletra (lopinavir/ritonavir) Oral Solution and Capsules
Ketek (telithromycin) Tablet
Methotrexate Injection (Preservative) and (Preservative-Free)
Norvir (ritonavir) Oral Solution, Tablets and Soft Gelatin Capsules
Opdivo (nivolumab) Injection
Rapamune (sirolimus) Oral Solution and Tablets
Sarafem (fluoxetine hydrochloride) Capsules
Treanda (bendamustine hydrochloride) for Injection
Tybost (cobicistat) Tablet
Zortress (everolimus) Tablets
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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