Drug Safety Labeling Changes - May  2016

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Food and Drug Administration (FDA) announces important safety label changes for prescription drugs almost every month. By implementing the label changes the FDA warns a physician of new side- effects, adverse reactions, contra-indications and precautions necessary for a drug. This information is important for safe practice of medicine.

Key to Label Sections

  • C - Contraindications
  • W - Warnings
  • P - Precautions
  • AR - Adverse Reactions

Drug Name Sections Modified
C W P AR
Alprostadil - for injection (Caverject Impulse) - -
Ceftaroline - fosamil (Teflaro) -
Diclofenac - - -
Diclofenac - (Voltaren Gel) - -
Diclofenac (Voltaren) - -
Diclofenac (Voltaren-XR) - -
Diclofenac (Zipsor) - -
Diclofenac (Zorvolex) - -
Epinephrine - injection, USP (AUVI-Q Autoinjector) -
Epinephrine injection - Auto-Injector (EpiPen and EpiPen Jr.) -
Ethosuximide (Zarontin) - -
Ezogabine -
Fulvestrant - (Faslodex) - -
Indomethacin - Indocin SR - -
Indomethacin - Tivorbex - -
Indomethacin -Indocin Suppositories - -
Interferon beta-1b (Extavia) -
Lithium - carbonate USP (Lithobid) - -
Lumacaftor/ Ivacaftor (Orkambi) - -
Mefenamic acid (Ponstel) - -
Meloxicam - Mobic Suspension - -
Meloxicam - Mobic Tablets - -
Naproxen (naprosyn) - -
Nicotine - transdermal system Patch - - -
Nicotine transdermal system -Nicoderm CQ - - -
Nivolumab (Opdivo) -
Rofecoxib - -
Abiraterone acetate -
Adrenalin (epinephrine injection, USP) -
Alprostadil - for injection - - -
Anakinra - - -
Azithromycin
Azithromycin - for injection
-
Busulfan - - -
Cabozantinib - -
Canagliflozin - -
Canagliflozin and Metformin HCl - Invokamet -
Cefepime - Injection -
Celecoxib - -
Cobimetinib - -
Diclofenac - -
Diclofenac - (Cataflam) - -
Diclofenac - (Flector ) - -
Diclofenac Potassium (Cambia) - -
Diclofenac (Pennsaid 1.5% ) - -
Diclofenac (Pennsaid 2% ) - -
Diclofenac sodium/ Misoprostol
Dobutamine - in 5% Dextrose Injection, USP in Flexible Plastic Containers -
Doxycycline - Delayed-release Tablets - -
Epinephrine - Injection, USP (epinephrine, 1:1000) -
Eplerenone -
Fenoprofen - -
Flurbiprofen - -
Haloperidol - Lactate
Haloperidol - Decanoate
- - -
Ibrutinib - - -
Ibuprofen - -
Ibuprofen and famotidine
Iloperidone - -
indomethacin - -
Indomethacin - Indocin Capsules - -
Indomethacin - Indocin Suspension - -
Ketorolac - -
Ketorolac- Ophthalmic Solution - - -
Lenvatinib - -
Lomitapide - -
Lorazepam - - -
Mipomersen -
Naproxen - -
Naproxen (naprelan) - -
Naproxen (naprosyn -EC) - -
Naproxen (naprosyn suspension) - -
Naproxen and Sumitriptan - -
Naproxen/ Esomeprazole
Natalizumab - -
Orlistat capsules - - -
Oxaprozin - -
Pazopanib - - -
Piroxicam - -
Pralatrexate - injection - - -
Rivaroxaban - -
Rosuvastatin - -
Sterile Water for Injection, USP - - -
Suvorexant - - - -
Tigecycline - - -
Twinject, Adrenaclick & Epinehrine Injection USP Auto-Injector -
Vemurafenib (Zelboraf) -

2016 - Monthly Summary Report for Drug Label Changes

2015 - Monthly Summary Report for Drug Label Changes

2014 - Monthly Summary Report for Drug Label Changes

2013 - Monthly Summary Report for Drug Label Changes

2012 - Monthly Summary Report for Drug Label Changes

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