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Labeling Changes and Instructions for 29 Products Updated April 2016

May 25, 2016

Safety Labeling Changes posted by MedWatch April 2016 includes 29 products 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:

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

Paper handouts are available from the U.S. Food and Drug Administration (FDA) that come with numerous prescription medications. They contain information that can help patients avoid potentially adverse events.

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