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:
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Product Name: Trade (Active Ingredient) or Product Class
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Potential Signal of a Serious Risk / New Safety Information
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Additional Information (as of December 20, 2019)
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Cisplatin
Generic products containing cisplatin
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Aortic thrombosis
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FDA is evaluating the need for regulatory action.
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Cyclin-dependent kinase 4 and 6 (CDK 4 and CDK 6) inhibitors
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Interstitial lung disease/pneumonitis
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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
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Pentosan polysulfate sodium (Elmiron)
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Eye disorders
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FDA is evaluating the need for regulatory action
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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)
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Renal toxicity
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FDA is evaluating the need for regulatory action.
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Bosutinib monohydrate (Bosulif)
Imatinib mesylate (Gleevec)
Ponatinib (Iclusig)
Generic products containing imatinib
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Thyroid dysfunction
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FDA is evaluating the need for regulatory action.
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Vancomycin hydrochloride (Firvanq)
Vancomycin hydrochloride (Vancocin)
Generic products containing vancomycin
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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
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FDA is evaluating the need for regulatory action.
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Fluoroquinolones
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Moxifloxacin hydrochloride (Avelox)
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Delafloxacin meglumine (Bexdela)
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Ciprofloxacin (Cipro)
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Ciprofloxacin (Cipro XR)
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Gemifloxacin mesylate (Factive)
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Levofloxacin (Levaquin)
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Moxifloxacin
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Generic products containing fluoroquinolones
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Risk of mitral and aortic regurgitation
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FDA is evaluating the need for regulatory action.
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Glatiramer acetate
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Drug device usage errors
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FDA is evaluating the need for regulatory action.
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Deoxycholic acid (Kybella)
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Injection site scarring
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FDA is evaluating the need for regulatory action.
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Baricitinib (Olumiant)
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Hypersensitivity reaction
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FDA is evaluating the need for regulatory action.
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Oritavancin diphosphate (Orbactiv)
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Infusion-related reactions
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FDA is evaluating the need for regulatory action.
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Tacrolimus capsule
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Therapeutic inequivalence
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FDA is evaluating the need for regulatory action
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Capecitabine (Xeloda),
generic products containing capecitabine
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Cerebellar toxicity
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FDA is evaluating the need for regulatory action
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Baloxavir marboxil (Xofluza)
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Serious skin reactions
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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
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Axicabtagene ciloleucel (Yescarta)
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Dysphagia
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FDA is evaluating the need for regulatory action
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