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  6. January – March 2015 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
  1. Questions and Answers on FDA's Adverse Event Reporting System (FAERS)

January – March 2015 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Product Name: Trade (Active Ingredient) or Product Class Potential Signal of a Serious Risk / New Safety Information Additional Information
(as of August 26, 2019)

 

Harvoni (ledipasvir/sofosbuvir) tablet

Olysio (simeprevir) capsule

Sovaldi (sofosbuvir) tablet

Cardiac arrhythmia, bradycardia

“Warning and Precautions,” “Adverse Reactions,” and “Drug Interactions” sections of the labeling and the patient package insert were updated to include information on the occurrence of serious symptomatic bradycardia when the antiarrhythmic drug amiodarone is taken with hepatitis C treatments containing ledipasvir/sofosbuvir (Harvoni) or with sofosbuvir (Sovaldi) taken in combination with another direct-acting antiviral.

Harvoni Labeling

Olysio Labeling

Sovaldi Labeling

Harvoni and Sovaldi Drug Safety Communication (3/24/15)

Juxtapid (lomitapide mesylate) capsule

Ineffectiveness of the REMS

Updated

The Boxed Warning, Indications for Usage, Dosage and Administration, and Warnings and Precautions sections of lomitapide mesylate product labeling were updated in May 2016.

Juxtapid label 

Juxtapid (lomitapide mesylate) capsule

Severe diarrhea

Updated

The Warnings and Precautions section of lomitapide mesylate product labeling was updated in May 2016 to include the risk of severe diarrhea.  

Juxtapid label 

Myalept (metreleptin) injection

Anaphylaxis

The “Warnings and Precautions” and “Contraindications” sections of the labeling were updated to include anaphylaxis.

Myalept Labeling

Noxafil (posaconazole) delayed-release tablet, oral suspension, and injection

Dosing and administration errors associated with product labeling (only oral product formulations)

The “Dosage and Administration” section of the labeling was updated to include information that the delayed-release tablet and oral suspension are not interchangeable due to the differences in the dosing of each formulation. Also, the outer carton/container now includes an “attention” statement.

Noxafil Labeling

Noxafil Drug Safety Communication (1/4/2016)

Pomalyst (pomalidomide) capsule

Hepatotoxicity

The “Warnings and Precautions” section of the labeling was updated to include hepatotoxicity.

Pomalyst Labeling

Tyvaso (treprostinil) inhalation solution

Nebulizer battery overheating

Starting in April 2013, the battery pack was redesigned and included on all new nebulizers.

Previously distributed nebulizers were replaced by the new battery pack. By June 2015, all U.S. Tyvaso patients should have transitioned to the new battery pack.

The sponsor reports no complaints of thermal events with the new battery pack.