April - June 2019 | 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 September 18, 2019) |
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Hypersensitivity/Acute respiratory failure | FDA is evaluating the need for regulatory action. |
Fasenra (benralizumab) | Flu-like illness | FDA is evaluating the need for regulatory action. |
Fasenra (benralizumab) | Herpes zoster | FDA is evaluating the need for regulatory action. |
|
Fetal death | FDA is evaluating the need for regulatory action. |
Gamunex-C [Immune Globulin (Human), 10% Caprylate/Chromatography Purified] | Increased hypersensitivity reactions in patients receiving certain product lots | FDA is evaluating the need for regulatory action |
|
Tumefactive multiple sclerosis | FDA is evaluating the need for regulatory action. |
|
Thrombocytopenia | FDA is evaluating the need for regulatory action. |
HMG-CoA reductase inhibitors
|
Immune-mediated necrotising myopathy | FDA is evaluating the need for regulatory action. |
Increlex (mecasermin) | Malignancies | FDA is evaluating the need for regulatory action. |
|
Drug hypersensitivity | FDA is evaluating the need for regulatory action. |
Mavyret (glecaprevir and pibrentasvir) | Hypersensitivity: angioedema and anaphylaxis | FDA is evaluating the need for regulatory action |
Ninlaro (ixazomib) | Thrombotic microangiopathy (TMA) | FDA is evaluating the need for regulatory action. |
|
Thrombotic microangiopathy (TMA) | FDA is evaluating the need for regulatory action. |
|
Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) | FDA is evaluating the need for regulatory action. |
Orencia (abatacept) | Angioedema | FDA is evaluating the need for regulatory action. |
Orbactiv (oritavancin diphosphate) | Anaphylaxis | FDA is evaluating the need for regulatory action. |
|
Chondrocalcinosis pyrophosphate | FDA is evaluating the need for regulatory action. |
Tecfidera (dimethyl fumarate) | Serious herpes infection | FDA is evaluating the need for regulatory action. |
|
Medication error – Labeling confusion (wrong drug errors) | FDA is evaluating the need for regulatory action. |
Velphoro (sucroferric oxyhydroxide) | Hemoglobin increased | FDA is evaluating the need for regulatory action. |
Vivitrol (naltrexone hydrochloride) | Medication Error - Patient self-administration errors | The carton labeling, sections of the product labeling (“Dosage and Administration”, “Warnings and Precautions,” “Adverse Reactions,” “How Supplied/Storage and Handling,” and “Patient Counseling”), and the Medication Guide, were updated to emphasize that Vivitrol must be injected by a healthcare provider. Vivitrol labeling |
Xofluza (baloxavir marboxil) | Anaphylaxis and angioedema | FDA is evaluating the need for regulatory action. |
Xofluza (baloxavir marboxil) | Medication error - Labeling confusion (wrong dose errors) | FDA is evaluating the need for regulatory action |
Yondelis (trabectedin) | Interstitial lung disease and mucositis | FDA is evaluating the need for regulatory action |