July - September 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 December 20, 2019) |
---|---|---|
Cisplatin |
Aortic thrombosis |
FDA is evaluating the need for regulatory action. |
Cyclin-Dependent Kinase 4 and 6 (CDK 4 and CDK 6) Inhibitors
|
Interstitial Lung Disease/Pneumonitis |
The Dosage and Administration, Warning and Precautions, and Patient Information sections of the labeling were updated September 2019 to include Interstitial Lung Disease/Pneumonitis. |
Elmiron (pentosan polysulfate sodium) |
Eye disorders |
FDA is evaluating the need for regulatory action. |
Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide) |
Renal toxicity |
FDA is evaluating the need for regulatory action. |
Bosulif (bosutinib monohydrate) |
Thyroid dysfunction |
FDA is evaluating the need for regulatory action. |
Firvanq (vancomycin hydrochloride) |
Serious cutaneous adverse reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute generalized exanthematous pustulosis (AGEP), and Linear IgA disease |
FDA is evaluating the need for regulatory action. |
Fluoroquinolones
|
Risk of mitral and aortic regurgitation |
FDA is evaluating the need for regulatory action. |
Glatiramer Acetate |
Drug device usage errors |
FDA is evaluating the need for regulatory action. |
Kybella (deoxycholic acid) |
Injection site scarring |
FDA is evaluating the need for regulatory action. |
Olumiant (baricitinib) |
Hypersensitivity reaction |
FDA is evaluating the need for regulatory action. |
Orbactiv (oritavancin diphosphate) |
Infusion-related reactions |
FDA is evaluating the need for regulatory action. |
Tacrolimus capsule |
Therapeutic inequivalence |
FDA is evaluating the need for regulatory action. |
Xeloda (capecitabine) |
Cerebellar toxicity |
FDA is evaluating the need for regulatory action. |
Xofluza (baloxavir marboxil) |
Serious skin reactions |
The Contraindications, Warnings and Precautions, Adverse Reactions and Patient Counseling Information sections of the baloxavir marboxil labeling were updated in October 2019 to include adverse reactions of erythema multiforme and rash. |
Yescarta (axicabtagene ciloleucel) |
Dysphagia |
FDA is evaluating the need for regulatory action. |