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# FDA Releases Safety Labeling Changes for 35 Drugs
- URL: https://www.fdaweb.com/fda-releases-safety-labeling-changes-for-35-drugs/
- Published: 2016-04-19T12:00:00.000Z
- Updated: 2026-09-14T20:55:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135415

> FDA has [released](http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm494849.htm?ref=fdaweb.com) safety labeling changes 35 drugs that were approved 3/2016, including a Contraindication for hypersensitivity in Janssen’s **Invega** (paliperidone) extended-release tablets and extended-release injectable suspension, Janssen’s **Invega Trinza** (peliperidone/palmitate) extended-release injectable suspension, and Janssen’s **Risperdal** (risperidone) tablets, oral solution, and orally-disintegrating tablets, and **Risperdal Consta** long acting injection.  
>  
> The labeling Contraindications section also was changed in Janssen’s **Invokamet** (canagliflozin and metformin HCl) tablets, Janssen’s **Invokana** (canagliflozin) tablets, Baxter’s **Plasma-Lyte 56 and 5% dextrose** injection, Genzyme’s **Renagel** (sevelamer HCl) tablets, Genzyme’s **Renvela** (sevelamer carbonate) powder for oral suspension, and AstraZeneca’s **Tudorza Pressair** (aclidinium bromide inhalation powder).  
>  
> Changes were approved in the Warnings sections of labeling for Seattle Genetics’ **Adcetris** (brentuximab vedotin) for injection, The Medicine Company’s **Angiomax** (bivalirudin) lyophilized powder for injection, Bristol-Myers Squibb’s **Droxia** (hydroxyurea) and **Hydrea** (hydroxyurea) capsules, AstraZeneca’s **Faslodex** (fulvestrant) solution for injection, Genentech’s **Herceptin** (trastuzumab) intravenous infusion, Merck’s **Implanon** (etonogestrel) implant, Incyte’s **Jakafi** (ruxolitinib phosphate) tablet, Aegerion’s **Juxtapid** (lomitapide) capsules, Organon’s **Nexplanon** (etonogestrel) implants, Actavis’ **Oxytrol for Women** (oxybutynin) transdermal system, Gilead’s **Truvada** (emtricitabine/tenofovir disoproxil fumarate) tablets, Novartis’ **Xgeva** (denosumab, AMG 162; human monoclonal antibody to RANK ligand), and Sandoz’ **Zarxio** (filgrastim-sndz).  
>  
> The Precautions sections were changed in labeling for **furosemide tablets** and US Pharma’s **Lasix** (furosemide) tablets, Gilead’s **Genvoya** (elvitegravir, cobicistat, emtricitabine, and tenofovir alfenamide) fixed-dose combination tablet, Roche’s **Klonopin** (clonazepam) tablets, Janssen’s **Prezcobix** (darunavir and cobicistat) tablet, and Bristol-Myers Squibb’s **Sustiva** (efavirenz) capsules and tablets.  
>  
> Finally, Adverse Reactions sections were changed in labeling for Pharmacia & Upjohn’s **Cleocin** **HCl** (clindamycin HCl) capsules, **Cleocin phosphate** (clindamycin) injection, and (clindamycin injection in 5% dextrose) solution in Galaxy plastic containers, Ipsen’s **Increlex** (mecasermin \[rDNA origin\] injection, ThromboGenics’ **Jetrea** (ocriplasmin intravitreal) injection, Sanofi’s **Zaltrap** (ziv-aflibercept) injection, and Novartis’ **Zometa** (zoledronic acid) injection.