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  6. July - September 2019 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
  1. Questions and Answers on FDA's Adverse Event Reporting System (FAERS)

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
Generic products containing cisplatin

Aortic thrombosis

FDA is evaluating the need for regulatory action.

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

FDA is evaluating the need for regulatory action.

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

FDA is evaluating the need for regulatory action.

Bosulif (bosutinib monohydrate)
Gleevec (imatinib mesylate)
Iclusig (ponatinib)
Generic products containing imatinib

Thyroid dysfunction

FDA is evaluating the need for regulatory action.

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

FDA is evaluating the need for regulatory action.

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 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)
Generic products containing 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.

Xofluza label

Yescarta (axicabtagene ciloleucel)

Dysphagia

FDA is evaluating the need for regulatory action.