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. |
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 (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. |
Myalept (metreleptin) injection |
Anaphylaxis |
The “Warnings and Precautions” and “Contraindications” sections of the labeling were updated to include anaphylaxis. |
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. |
Pomalyst (pomalidomide) capsule |
Hepatotoxicity |
The “Warnings and Precautions” section of the labeling was updated to include hepatotoxicity. |
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. |