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The MedWatch April 2016 Safety Labeling Changes posting includes 29 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/ucm499575.htm
The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, or PRECAUTIONS sections:
Aciphex (rabeprazole sodium) Delayed-release Tablets, for Oral Use and Aciphex Sprinkle (rabeprazole sodium delayed-release capsules)
Betaseron (interferon beta-1b) for Injection, for Subcutaneous Use
Cialis (tadalafil) Tablets, For Oral Use
Cimzia (certolizumab pegol) for Injection, for Subcutaneous Use
Cordarone (amiodarone HCl) Tablets
Gilotrif (afatinib) Tablets, for Oral Use
Kadcyla (ado-trastuzumab emtansine) for Injection, for Intravenous Use
Lenvima (lenvatinib) Capsules, for Oral Use
Limbitrol (chlordiazepoxide and amitriptyline HCI) and Limbitrol DS
Lopid (gemfibrozil Tablets, USP)
Nesina (alogliptin) Tablets, for Oral Use
Nplate (romiplostim) for Injection, for Subcutaneous Use
Onglyza (saxagliptin) Tablets, for Oral Use
Oxaliplatin Injection for Intravenous Use
Precedex (dexmedetomidine hydrochloride) Injection and Precedex (dexmedetomidine hydrochloride) in 0.9% Sodium Chloride Injection
Ringer’s Injection, USP in VIAFLEX Plastic Container
Skyla (levonorgestrel-releasing intrauterine system)
Tivicay (dolutegravir) Tablets, For Oral Use
Triumeq (abacavir, dolutegravir, and lamivudine) Tablets, For Oral Use
Vibramycin (doxycycline hyclate) Intravenous
Vibramycin Monohydrate (doxycycline monohydrate) for Oral Suspension, Vibramycin Hyclate (doxycycline hyclate capsules, USP), Vibramycin Calcium (doxycycline calcium oral suspension) Syrup, Vibra-Tabs (doxycycline hyclate tablets, USP)
Viekira PAK (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets), Co-packaged for Oral Use
Zestril (lisinopril) Tablets, for Oral Use
Zonegran (zonisamide) Capsules, for Oral Administration
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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