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# 86 Drug Safety Labeling Changes Posted
- URL: https://www.fdaweb.com/86-drug-safety-labeling-changes-posted/
- Published: 2016-06-16T12:00:00.000Z
- Updated: 2026-09-14T21:10:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135957

FDA has posted drug safety labeling changes approved for 86 drugs, including a new Boxed Warning for risks of cardiovascular thrombotic events, heart failure, and edema for 39 drugs — Atnahs’ **Anaprox** (naproxen), **Ansaid** (flurbiprofen), Searle’s **Arthrotec** (diclofenac sodium/misoprostol), Cumberland’s **Caldolor** (ibuprofen), Depomed’s **Cambia** (diclofenac potassium), **Cataflam** (diclofenac), Pfizer’s **Celebrex** (celecoxib), Searle’s **Daypro** and **Daypro Alta** (oxaprozin), Horizon’s **Duexis** (ibuprofen and famotidine), Javelin’s **Dyloject** (diclofenac), Pfizer’s **Feldene** (piroxicam), Inst Biochem’s **Flector** (diclofenac), **Indocin** (indomethacin) capsules, **Indocin SR**, suppositories and Iroko’s **Indocin Suspension**, **indomethacin**, Boehringer Ingelheim’s **Mobic** (meloxicam) suspension and tablets, Xspire’s **Nalfon** (fenoprofen), Alvogen Malta’s **Naprelan** (naproxen), Atnahs’ **Naprosyn** (naproxen), PediaPharma’s **Naprosyn Suspension** (naproxen), Atnahs’ **Naprosyn-EC** (naproxen), Nuvo Res’ **Pennsaid 1.5%** (diclofenac), Horizon’s **Pennsaid 2%** (diclofenac), Shionogi’s **Ponstel** (mefenamic acid), Fougera’s **Solaraze** (diclofenac sodium), Egalet’s **Sprix** (kertolac), Iroko’s **Tivorbex** (indomethacin), Pernix Ireland’s **Treximet** (naproxen and sumitriptan), Horizon’s **Vimovo** (naproxen/esomeprazole magnesium), Merck’s **Vioxx** (rofecoxib), Novartis’ **Voltaren** (diclofenac), GlaxoSmithKline’s **Voltaren Gel** (diclofenac), **Voltaren-XR** (diclofenac), Depomed’s **Zipsor** (diclofenac), and Iroko’s **Zorvolex** (diclofenac).

New Boxed Warnings also were approved for Vanda’s **Fanapt** (iloperidone), Janssen’s **Invokamet** (canagliflozin and merformin HCl), Aegerion’s **Juxtapid** (lomatipide), Genzyme’s **Kynamro** (mipomersen), and GlaxoSmithKline’s **Potiga** (ezogabine).

Changes to the Contraindications sections were approved in labeling for IPR’s **Crestor** (rosuvastatin calcium) and **Dobutamine in 5% dextrose injection in flexible plastic containers**.

Changes to the Warnings sections were approved in labeling for Par’s **Adrenalin** (epinephrine injection), GlaxoSmithKlines’ **alli** (orlistat) capsules, Kaleo’s **AUVI-Q** autoinjector (epinephrine injection), Pharmacia & Upjohn’s **Caverject Impulse** (alprostadil for injection), **cefepime injection**, Exelixis’ **Cometriq** (cabozatinib), Genentech’s **Cotellic** (cobimetinib), Mayne’s **Doryx** (doxycycline hyclate delayed-release tablets), **epinephrine injection**, Mylan’s **EpiPen and EpiPen Jr.** (epinephrine injection), Novartis’ **Extavia** (interferon beta-1b), AstraZeneca’s **Faslodex** (fulvestrant), Dr. Reddy’s **Habitrol** (nicotine transdermal system), Janssen’s **Invokana** (canagliflozin), Searle’s **Inspra** (eplerenone), Eisai’s **Lenvima** (lenvatinib), Ani Pharm’s **Lithobid** (lithium carbonate), GlaxoSmithKline’s **Nicoderm CQ** (nicotine transdermal system), Bristol-Myers Squibbs’ **Opdivo** (nivolumab), Vertex’ **Orkambi** (lumacaftor/ivacaftor), **sterile water for injection**, Cerexa’s **Teflaro** (ceftaroline fosamil), Shionogi’s **Twinject, Adrenaclick & Epinephrine injection auto-injector**, Biogen’s **Tysabri** (natalizumab), Janssen’s **Xarelto** (rivaroxaban), Parke Davis’ **Zarontin** (ethosuximide), Hoffmann LaRoche’s **Zelboraf** (vemurafenib), Pfizer’s **Zithromax** (azithromycin) and **Zithromax IV** (azithromycin for injection), and Janssen’s **Zytiga** (abiraterone acetate).

Changes were approved in the Precautions sections of labeling for Valeant’s **Ativan** (lorazepam), Pfizer’s **Caverject sterile powder** (alprostadil for injection), Allos’ **Folotyn** (pralatrexate injection), and Novartis’ **Votrient** (pazopanib).

Changes to the Adverse Reactions sections were approved in labeling for Allergen’s **Acular LS** (ketorolac tromethamine ophthalmic solution), **Busulfex** (busulfan), Janssen’s **Haldol** (haloperidol lactate) and (haloperidol decanoate), Pharmacyclics’ **Imbruvica** (ibrutinib), SOBI’s **Kineret** (anakinra), and PF Prism’s **Tygacil** (tigecycline).

A new Medication Guide was approved for Merck’s **Belsomra** (suvoexant).