86 Drug Safety Labeling Changes Posted
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).