Drug Safety Labeling Changes - March  2015

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
Aliskiren/ Hydrochlorothiazide - Tablets -
Levalbuterol - Tartrate Inhalation Aerosol - - -
Lopinavir/Ritonavir - Oral Solution, Tablets, Capsules - -
Pazopanib - Tablets -
Sterile Cefoperazone Injection - -
Abacavir Sulfate - Tablets, Oral Solution - -
Acarbose - Tablets - - -
Albiglutide - Injection, for Subcutaneous Use - -
Aliskiren - Tablets -
Aliskiren/ Amlodipine Besylate/ Hydrochlorothiazide - Tablets -
Aliskiren/ Amlodipine -Tablets -
Alprostadil - for Injection - - -
Amiodarone - Premixed Injection -
Amiodarone - Tablets - -
Amlodipine - Besylate Tablets - -
Artemether/ Lumefantrine Tablets - - -
Asenapine - Sublingual Tablets - - -
Atazanavir - Capsules, Oral Powder - -
Atorvastatin - Tablets - - -
Atorvastatin/Amlodipine -Tablets - -
Bandronate - Sodium Tablets - - -
Calcipotriene - Cream and Ointment - -
Canagliflozin - Tablets - - -
Canagliflozin and Metformin HCl - Tablets - - -
Capecitabine - Tablets - - -
Capecitabine - Tablets -
Carfilzomib - for Injection - -
Cefotaxime - Injection
Cefotaxime - Sterile IM/IV
- - -
Cenestin (Synthetic Conjugated Estrogens, A) Tablets -
Cetuximab - Injection for Intravenous Infusion -
Cyclosporine - Injection, Oral Solution, Soft Gelatin Capsules - -
Cyclosporine - Soft Gelatin Capsules, Oral Solution - -
Darunavir - Tablets, Oral Suspension - -
Depakene (Valproic Acid) Capsules, Oral Solution, Delayed Release Tablets
Depakote Sprinkle Capsules (Divalproex Sodium) Delayed Release Capsules
Depacon (Valproate Sodium) Injection
Depakote ER (Divalproex Sodium) Extended Release Tablets
- - -
Diltiazem - Extended Release Tablets - -
Dulaglutide - Injection, for Subcutaneous Use - -
Efavirenz - Capsules, Tablets - - -
Estradiol - Topical Emulsion
Etidronate - Tablets - - -
Exenatide - Extended-Release for Injectable Suspension - -
Ferumoxytol - Injection
Fluticasone Furoate and Vilanterol - Inhalation Powder - -
Fosamprenavir - Calcium Tablets, Oral Suspension - -
Indinavir - Capsules - -
Interferon beta-1a Injection - - -
Ivacaftor - Tablets - - -
Lamotrigine - Tablets, Chewable Dispersible Tablets, Orally Disintegrating Tablets, Extended-release Tablets -
Ledipasvir/ Sofosbuvir - Fixed-dose Combination Tablet -
Levetiracetam - Tablets, Oral Solution, Extended-release Tablets -
Liraglutide [rDNA origin]) Injection Solution for Subcutaneous Use - -
Minocycline - Pellet-filled Capsules - - -
Nelfinavir Mesylate - Oral Powder, Tablets - -
Palifermin- Injection - - -
Panitumumab - Injection for Intravenous Infusion - -
Peginterferon alfa-2a Injection, for Subcutaneous Use -
Perindopril Erbumine - Tablets - - -
Pioglitazone and Glimepiride - Tablets
Risedronate - Delayed-release Tablets
Risedronate -Tablets with Calcium Carbonate Tablets
Risedronate - Tablets
- -
Ritonavir - Capsules, Oral Solution, Tablets - -
Ritonavir- Tablets, Oral Solution, Soft Gelatin Capsules - - -
Rosiglitazone Maleate and Glimepiride Tablets
Saquinavir - Capsules, Tablets - -
Sildenafil Citrate - Tablets, for Oral Use - -
Sirolimus -Oral Solution, Tablets - - -
Sofosbuvir - Tablet -
Ulipristal Acetate - Tablets - -

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

Facebook