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 August 5, 2024) |
---|---|---|
Cisplatin |
Aortic thrombosis |
Updated
FDA has determined that the last approved labeling is adequate, and that no further regulatory action is needed at this time. |
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 |
Updated
The “Warnings”, “Adverse Reactions”, and “Patient Leaflet” sections of the labeling were updated in June 2020 to include potential risk of pigmentary maculopathy and visual symptoms. |
Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide) |
Renal toxicity |
Updated
The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling for tenofovir alafenamide containing products were updated between March 2021 and June 2021 to include information regarding the risk of renal toxicity associated with the use of tenofovir alafenamide. Example: Odefsy labeling |
Bosulif (bosutinib monohydrate) |
Thyroid dysfunction |
Updated
The “Adverse Reactions” section of the labeling was updated between June 2020 and August 2020 to include hypothyroidism and hyperthyroidism. |
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 |
Updated
The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling were updated in January 2021 to include severe dermatologic reactions [i.e., Drug reaction eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), Toxic epidermal necrolysis (TEN), Acute generalized exanthematous pustulosis (AGEP), and Linear IgA bullous dermatosis (LABD)]. |
Fluoroquinolones
|
Risk of mitral and aortic regurgitation |
Updated
FDA decided that no action is necessary at this time based on available information. |
Glatiramer Acetate |
Drug device usage errors |
Updated
The “Patient Counseling Information” section of the labeling was updated in January 2022 to include information on usage of optional autoinjectors. FDA issued a Drug Alert to patients, caregivers, and healthcare providers of cross-compatibility issues with autoinjector devices that are optional for use with glatiramer acetate injection on August 18, 2022, and provided an update on May 16, 2024. |
Kybella (deoxycholic acid) |
Injection site scarring |
FDA is evaluating the need for regulatory action. |
Olumiant (baricitinib) |
Hypersensitivity reaction |
Updated
The “Warnings and Precautions” and “Adverse Reactions” sections of the labeling was updated in July 2020 to include hypersensitivity reactions. |
Orbactiv (oritavancin diphosphate) |
Infusion-related reactions |
Updated
The “Warnings and Precautions” section of the labeling was updated in December 2019 to include infusion-related reactions. |
Tacrolimus capsule |
Therapeutic inequivalence |
Updated
FDA issued a Drug Alert as well as Questions and Answers regarding a change to the therapeutic equivalence rating for Accord Healthcare Inc.’s generics of Prograf (tacrolimus) oral capsules on September 18, 2023. |
Xeloda (capecitabine) |
Cerebellar toxicity |
Updated
FDA decided that no action is necessary at this time based on available information. |
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 |
Updated
The “Adverse Reactions” section of the labeling was updated to include dysphagia. |