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

Product Name: Trade (Active Ingredient) or Product Class Potential Signal of a Serious Risk / New Safety Information Additional Information
(as of January 13, 2016)


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

FDA is evaluating the need for regulatory action.

Juxtapid (lomitapide mesylate) capsule

Severe diarrhea

FDA is evaluating the need for regulatory action.

Myalept (metreleptin) injection


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


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.





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