In April 2016, 29 drug products have had changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE.
See below for a list of drugs that had modifications to the specified 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
For more information about the specific safety labeling changes, go to the FDA’s website. For general information about drug labeling changes and monthly summaries, click here.
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