July - September 2019 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Cisplatin
Generic products containing cisplatin

Aortic thrombosis

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

• Ibrance (palbociclib)
• Kisqali (ribociclib)
• Kisqali Femara Co-Pack (letrozole and ribociclib)
• Verzenio (abemaciclib)

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.

Ibrance label

Kisqali label

Verzenio label

FDA Drug Safety Communication

Elmiron (pentosan polysulfate sodium)

Eye disorders

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.

Elmiron labeling

Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide)
Descovy (emtricitabine and tenofovir alafenamide)
Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide)
Odefsey (emtricitabine, rilpivirine, and tenofovir alafenamide)
Symtuza (darunavir, cobicistat,  emtricitabine, and tenofovir alafenamide)
Vemlidy (tenofovir alafenamide)

Renal toxicity

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)
Gleevec (imatinib mesylate)
Iclusig (ponatinib)
Generic products containing imatinib

Thyroid dysfunction

The “Adverse Reactions” section of the labeling was updated between June 2020 and August 2020 to include hypothyroidism and hyperthyroidism.

Bosulif labeling

Gleevec labeling

Iclusig labeling

Firvanq (vancomycin hydrochloride)
Vancocin (vancomycin hydrochloride)
Generic products containing vancomycin

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

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)].

Vancocin labeling

Firvanq labeling

Fluoroquinolones

• Avelox (moxifloxacin hydrochloride)
• Bexdela (delafloxacin meglumine)
• Cipro (ciprofloxacin)
• Cipro XR (ciprofloxacin)
• Factive (gemifloxacin mesylate)
• Levaquin (levofloxacin)
• Moxifloxacin
• Generic products containing fluoroquinolones

 Risk of mitral and aortic regurgitation

FDA decided that no action is necessary at this time based on available information.

Glatiramer Acetate

Drug device usage errors

The “Patient Counseling Information” section of the labeling was updated in January 2022 to include information on usage of optional autoinjectors.

Glatiramer Acetate labeling

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.

Drug Alert (05/16/2024)

Kybella (deoxycholic acid)

Injection site scarring

FDA is evaluating the need for regulatory action.

Olumiant (baricitinib)

Hypersensitivity reaction

The “Warnings and Precautions” and “Adverse Reactions” sections of the labeling was updated in July 2020 to include hypersensitivity reactions.

Olumiant labeling

Orbactiv (oritavancin diphosphate)

Infusion-related reactions

The “Warnings and Precautions” section of the labeling was updated in December 2019 to include infusion-related reactions.

Orbactiv labeling

Tacrolimus capsule

Therapeutic inequivalence

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.

Drug Alert (09/18/2023)

Questions and Answers (09/18/2023)

Xeloda (capecitabine)
Generic products containing capecitabine

Cerebellar toxicity

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.

Xofluza label

Yescarta (axicabtagene ciloleucel)

Dysphagia

The “Adverse Reactions” section of the labeling was updated to include dysphagia.

Yescarta labeling