Drug Safety Labeling Changes - April  2014

Email bookmark
Font : A-A+

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
-
Acetaminophen 250 mg, Aspirin 250 mg, Caffeine 65 mg) Tablets, Caplets and Geltabs - - -
Buprenorphine and Naloxone - Sublingual Film - -
Clindamycin - Lotion, Solution, and Gel, 1 Percent - - -
Fingolimod - -
Hydromorphone - Extended-Release Capsules - -
Hydromorphone -Extended-Release Tablets - -
Morphine - Extended-Release Capsules - -
Nitroglycerin - USP 0.3, 0.4, 0.6 mg Sublingual Tablets - - -
Pegaspargase -
Sapropterin Dihydrochloride - -
125 Phenytoin - Oral Suspension and Phenytoin Injection - - -
Acyclovir 5 Percent Cream - - - -
Alfuzosin - Extended Release Tablets - - -
Avanafil - -
Azilsartan Medoxomil - 40 mg and 80 mg Tablets - - -
Azilsartan Medoxomil and Chlorthalidone - 40 mg/12.5 mg and 40/25 mg Tablets - - -
Belimumab - -
Buprenorphine -Transdermal System - -
Darunavir - tablets, 75 mg, 150 mg, 600 mg, and 800 mg
Darunavir - oral suspension, 100 mg/mL
- -
Dasatinib - 20, 50, 70, 80, 100 and 140 mg Tablets - -
Delflex Peritoneal Dialysis (PD) Solutions (1.5%, 2.5% and 4.25% Dextrose with Standard Calcium/Standard Magnesium and with Standard Calcium/Low Magnesium)
Delflex PD Solutions (1.5%, 2.5% and 4.25% Dextrose with Low Calcium/Low Magnesium)
- -
Desloratadine - Tablets,
Desloratadine - Oral Solution,
Desloratadine - Reditabs
- - -
Docetaxel - Injection Solution for Intravenous Infusion, 10 mg/mL, 20 mg/12mL, 80 mg/8mL, and 160 mg/16mL - - -
Erlotinib - Tablets, 25mg, 100mg and 150mg -
Fentanyl - Transdermal System - -
Iloperidone - 1, 2, 4, 6, 8, 10, and 12 mg tablets - - -
Interferon beta-1a Injection - - -
Ketorolac - Nasal Spray - - -
Lovastatin - Extended-Release Tablets; 20, 40, and 60 mg - - -
Methadone - Tablets - -
Mometasone Furoate and Formoterol Fumarate - Inhalation Aerosol - - -
Morphine - Extended-Release Capsules - -
Morphine - Extended-Release Tablets - -
Morphine and Naltrexone - Extended-Release Capsules - -
Oxycodone - Extended-Release Tablets - -
Oxymorphone - Extended-Release Tablets - -
Paliperidone - Tablets, and Paliperidone - Extended-Release Suspension for Intramuscular Injection - -
Pentoxifylline - Extended-Release Tablets, 400 mg - - -
Raltegravir - film-coated tablets, 400 mg
Raltegravir - chewable tablets, 25 mg, 100 mg
Raltegravir - for oral suspension, 100 mg
- - -
Risperidone -Tablets
Risperidone - Oral Solution
Risperidone - Orally Disintegrating Tablets
Risperidone Long Acting Injection
- - -
Sodium Oxybate - Oral Solution - - -
Tadalafil - 20 mg Tablets - -
Tadalafil - Tablets 5 mg - - - -
Tapentadol - Extended-Release Tablets - -
Temsirolimus - Injection, 25 mg/mL -
Tipranavir - Capsules, 250 mg, Tipranavir - Oral Solution, 100 mg/mL - -
Tobramycin - Inhalation Powder for Oral Inhalation, 28 mg - -
Tobramycin - Inhalation Solution, USP 300 mg/5mL - - -
Vardenafil - Orally Disintegrating Tablets - -
Vardenafil - Tablets - -
Vilazodone Hydrochloride - 10 mg, 20 mg, and 40 mg Tablets -
Voriconazole - Tablets
Voriconazole - for Injection
Voriconazole - for Oral Suspension
- -
Zoledronic Acid - Injection, 4 mg/100 mL single-use,ready-to-use bottle and 4 mg/5 mL single-use vial of concentrate -

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

Buy Medication (Drug) at Concessional Price from India

Drugs A - Z

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Drugs Search

Medindia Newsletters

Subscribe to our Free Newsletters!

Terms & Conditions and Privacy Policy.

Find a Doctor

Stay Connected

  • Available on the Android Market
  • Available on the App Store