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Drug Safety Labeling Changes - September 2014

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
Bimatoprost - ophthalmic solution, 0.03 percent
Bimatoprost - Ophthalmic Solution, 0.01 percent
Regadenoson - Injection
Belatacept
Bimatoprost - Ophthalmic Solution, 0.03 percent
Carbamazepine - Tablets, Chewable Tablets, Oral Suspension, Tegretol-XR Carbamazepine extended-release
Clofarabine - Injection, 1 mg/mL
Clozapine - 25 mg and 100 mg - Tablets
Dabigatran - 75 and 150 mg Capsules
Docetaxel - Injection Concentrate, 20 mg/1 mL, 80 mg/4 mL, and 140 mg/7 mL
Doxycycline - Intravenous
Doxycycline - for Oral Suspension
Doxycycline - Capsules
Doxycycline - Oral Suspension Syrup
Doxycycline - Film Coated Tablets
Ertapenem - Injection, 1 gm
Estradiol - Transdermal System 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, and 0.1 mg/day
Granisetron
Lanthanum Carbonate - Chewable Tablets 500 mg, 750 mg and 1000 mg
Lidocaine - Solution, 2 percent
Losartan - 25 mg, 50 mg, and 100 mg Tablets
Memantine - Extended-Release Capsule, 7 mg, 14 mg, 21 mg, and 28 mg
Nilotinib - Capsules, 150 and 200 mg
Omalizumab
Ondansetron - Oral Soluble Film
Ondansetron - Oral Solution
Ondansetron - Orally Disintegrating Tablets
Ondansetron -Injection
Ondansetron -Tablets
Palonosetron - Injection
Palonosetron - Oral Capsules
Selegiline - Transdermal System 6 mg/24 hours, 9 mg/24 hours, and 12 mg/24 hours
Simeprevir- 150 mg Capsules
Triazolam - Tablets, 0.25 mg
Valsartan - 40 mg, 80 mg, 160 mg, and 320 mg Tablets
Valsartan - 80 mg and 160 mg Capsules
Varenicline - Tablets; 0.5 mg and 1 mg

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

Drugs A-Z
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