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# FDA Publishes 31 Drug Safety Labeling Changes
- URL: https://www.fdaweb.com/fda-publishes-31-drug-safety-labeling-changes/
- Published: 2016-01-13T12:00:00.000Z
- Updated: 2026-09-15T02:27:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134421

> FDA has [published](http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm480758.htm?ref=fdaweb.com) safety labeling changes for 31 products approved 12/2015, including revised Warnings and Precautions for five multiple sclerosis drugs for cases of thrombotic microangiopathy — Biogen’s **Avonex** (interferon beta 1a), Bayer’s **Betaseron** (interferon beta 1b), Novartis’ **Extavia** (interferon beta 1b), Biogen’s **Plegridy** (peginterferon beta 1a), and Serono’s **Rebif** (interferon beta 1a).  
>  
> New Warnings language also was approved for Genzyme’s **Clolar** (clofarabine) injection, Pacira’s **Exparel** (bupivacaine liposome) injectable suspension, AstraZeneca’s **Farxiga** (dapagliflozin) tablets, Boehringer Ingelheim’s **Glyxambi** (empagliflozin and linagliptin) tablets, Ariad’s **Iclusig** (ponatinib) tablets, Hoffmann La Roche’s **Invirase** (saquinavir mesylate) capsules and tablets, Janssen’s **Invokana** (canagliflozin) tablets, Janssen’s **Invokamet** (canagliflozin and metformin HCl) tablets, Boehringer Ingelheim’s **Jardiance** (empagliflozin) tablets, Janssen’s **Ortho-Cept** (desogestrel/ethinyl estradiol) tablets, Supernus’ **Oxtellas** XR (oxcarbazepine) extended-release tablets, Boehringer Ingelheim’s **Synjardy** (empagliflozin and metformin HCl) tablets, Prism’s **Xeljanz** (tofacitinib) tablets, AstraZeneca’s **Xigduo** XR (dapagliflozin and metformin HCl extended release) tablets, Novartis’ **Xolair** (omalizumab) powder for injection, and Wyeth’s **Zosyn** (piperacillin and tazobactam) for injection.  
>  
> Precautions were changed in labeling for Astellas’ **Astagraf** XL (tacrolimus extended-release capsules), Takeda’s **Dexilant** (dexlansoprazole) delayed-release capsules, and Takeda’s **Prevacid** (lansoprazole) delayed-release capsules and orally disintegrating tablets.  
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> The Adverse Reactions sections were changed in labeling for Genentech’s **Avastin** (bevacizumab), Roche’s **Fuzeon** (enfuvirtide) lyophilized powder for injection, Boehringer Ingelheim’s **Gilotrif** (afatinib) tablets, Hospira’s **metronidazole** injection, Organon’s **Remeron** (mirtazapine) tablets and SofTab orally disintegrating tablets, Sanofi-Aventis’ **Taxotere** (docetaxel) injection concentrate, and Celgene’s **Vidaza** (azacitidine for injection).