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Drug Safety Labeling Changes - May 2016

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)
Diclofenac - (Voltaren Gel)
Epinephrine - injection, USP (AUVI-Q Autoinjector)
Fulvestrant - (Faslodex)
Indomethacin - Indocin SR
Indomethacin - Tivorbex
Indomethacin -Indocin Suppositories
Lithium - carbonate USP (Lithobid)
Meloxicam - Mobic Suspension
Meloxicam - Mobic Tablets
Nicotine - transdermal system Patch
Abiraterone acetate
Alprostadil - for injection
Anakinra
Cabozantinib
Canagliflozin
Cefepime - Injection
Celecoxib
Cobimetinib
Diclofenac
Diclofenac - (Cataflam)
Diclofenac - (Flector )
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
Iloperidone
indomethacin
Indomethacin - Indocin Capsules
Indomethacin - Indocin Suspension
Ketorolac
Ketorolac- Ophthalmic Solution
Lenvatinib
Lomitapide
Lorazepam
Naproxen
Natalizumab
Oxaprozin
Pazopanib
Piroxicam
Rivaroxaban
Rosuvastatin
Suvorexant
Tigecycline

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