Fluoroquinolones, Cancer Drugs on New FDA Watch List

Marcia Frellick

January 21, 2020

The new watch list from the US Food and Drug Administration (FDA) includes 15 drugs or drug classes for which there is a potential sign of serious risk or new safety information.

The watch list, updated to cover July through September 2019, is generated from the FDA Adverse Event Reporting System and is posted on the FDA website

Appearance on the list does not mean the FDA has found that a drug is associated with the corresponding risk, only that the agency has identified a potential safety problem. If further review shows it is associated with risk, the FDA can take actions — including requiring changes to labeling, restricting the drug's use, or in rare cases removing it from the market.

Eight fluoroquinolones made the list this quarter with potential signs of risk for mitral and aortic regurgitation.

The FDA has issued several prior safety communications about fluoroquinolone use, including in December 2018 (aortic aneurysm), July 2018 (significant decreases in blood sugar and certain mental health side effects), July 2016 (disabling adverse effects of the tendons, muscles, joints, nerves, and central nervous system), May 2016 (restrict use for certain uncomplicated infections), August 2013 (peripheral neuropathy), and July 2008 (tendinitis and tendon rupture).

The cancer drug cisplatin is being investigated for aortic thrombosis. And two drug classes on the list, cyclin-dependent kinase 4 and 6 (CDK 4 and CDK 6) inhibitors, showed potential links with interstitial lung disease/pneumonitis. That information was updated on the drugs' labels.

Six HIV drugs listed potential signs of risk for renal toxicity.

With baloxavir marboxil (Xofluza, Genentech), some sections of the labeling were updated this past October to include adverse reactions of erythema multiforme and rash.

This updated list includes:

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

  • Palbociclib  (Ibrance)

  • Ribociclib (Kisqali)

  • Letrozole and ribociclib (Kisqali Femara Co-Pack)

  • Abemaciclib (Verzenio)

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

Pentosan polysulfate sodium (Elmiron)

Eye disorders

FDA is evaluating the need for regulatory action

Bictegravir, emtricitabine and tenofovir alafenamide (Biktarvy)
 

Emtricitabine and tenofovir alafenamide (Descovy)
 

Elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide (Genvoya)
 

Emtricitabine, rilpivirine, and tenofovir alafenamide (Odefsey)
 

Darunavir, cobicistat, emtricitabine, and tenofovir alafenamide (Symtuza)
 

Tenofovir alafenamide (Vemlidy)

Renal toxicity

FDA is evaluating the need for regulatory action.

Bosutinib monohydrate (Bosulif)
Imatinib mesylate (Gleevec)
Ponatinib (Iclusig)
Generic products containing imatinib

Thyroid dysfunction

FDA is evaluating the need for regulatory action.

Vancomycin hydrochloride (Firvanq)
Vancomycin hydrochloride (Vancocin)
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

  • Moxifloxacin hydrochloride (Avelox)

  • Delafloxacin meglumine (Bexdela)

  • Ciprofloxacin (Cipro)

  • Ciprofloxacin (Cipro XR)

  • Gemifloxacin mesylate (Factive)

  • Levofloxacin (Levaquin)

  • 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.

Deoxycholic acid (Kybella)

Injection site scarring

FDA is evaluating the need for regulatory action.

Baricitinib (Olumiant)

Hypersensitivity reaction

FDA is evaluating the need for regulatory action.

Oritavancin diphosphate (Orbactiv)

Infusion-related reactions

FDA is evaluating the need for regulatory action.

Tacrolimus capsule

Therapeutic inequivalence

FDA is evaluating the need for regulatory action

Capecitabine (Xeloda),
generic products containing capecitabine

Cerebellar toxicity

FDA is evaluating the need for regulatory action

Baloxavir marboxil (Xofluza)

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

Axicabtagene ciloleucel (Yescarta)

Dysphagia

FDA is evaluating the need for regulatory action

 

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