January - March 2018 | Potential Signals of Serious Risks/New Safety Information
`Identified from 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 January 31, 2025)
`AccuNeb (albuterol
`sulfate) inhalation
`solution
`Combivent
`Respimat
`(ipratropium bromide
`and albuterol)
`inhalation spray
`DuoNeb
`(ipratropium
`bromide/albuterol
`sulfate) inhalation
`solution
`ProAir HFA
`(albuterol sulfate)
`inhalation aerosol
`Proair respiclick
`(albuterol sulfate)
`inhalation powder,
`for oral inhalation
`use
`Proventil HFA
`(albuterol sulfate)
`aerosol
`Ventolin HFA
`(albuterol sulfate)
`inhalation aerosol
`Xopenex HFA
`(levalbuterol tartrate)
`inhalation aerosol,
`for oral inhalation
`use
`Albuterol sulfate
`and serious skin
`reactions
`FDA decided that no action is necessary at this time based on available information.
`Actemra
`(tocilizumab)
`injection
`Arcalyst (rilonacept)
`injection
`Ilaris (canakinumab)
`injection
`Kevzara (sarilumab)
`injection
`Kineret (anakinra)
`injection
`IL-1 and IL-6
`inhibitors and
`pulmonary
`hypertension,
`interstitial lung
`disease,
`pulmonary
`alveolar
`proteinosis
`Updated
`FDA decided that no action is necessary at this time based on available information.
`Feedback
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`HELSINN EXHIBIT 2080
`Azurity Pharmaceuticals, Inc. v. Helsinn Healthcare S.A.
`IPR2025-00948
`Page 1 of 5
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`Product Name: Trade
`(Active Ingredient) or
`Product Class
`Potential Signal
`of a Serious Risk
`/ New Safety
`Information
`Additional Information
`(as of January 31, 2025)
`Adempas (riociguat)
`tablets
`Syncope FDA decided that no action is necessary at this time based on available information.
`Ambien (zolpidem
`tartrate) tablets
`Lunesta
`(eszopiclone) tablets
`Sonata (zaleplon)
`capsules
`Somnambulism,
`Abnormal Sleep-
`related event
`Updated
`The “Boxed Warning”, “Contraindications”, “Warnings”, “Precautions”, “Warnings and Precautions”,
`“Adverse Reactions”, “Patient Counseling Information”, and “Medication Guide” sections of the labeling
`were updated in February 2019 and August 2019 to include information about complex sleep behaviors.
`Example:
`Ambien labeling
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019908s046lbl.pdf)
`An FDA Drug Safety Communication (https://www.fda.gov/drugs/drug-safety-and-availability/fda-adds-
`boxed-warning-risk-serious-injuries-caused-sleepwalking-certain-prescription-insomnia) was issued on
`April 30, 2019.
`Bosulif (bosutinib)
`tablets
`Gleevec (imatinib
`mesylate) tablets
`Iclusig (ponatinib)
`tablets
`Sprycel (dasatinib)
`tablets
`Tasigna (nilotinib)
`capsules
`Thrombotic
`microangiopathy Updated
`The “Adverse Reactions” section of the labeling was updated between August 2018 and November 2018
`to include thrombotic microangiopathy.
`Example: Bosulif labeling (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203341s015lbl.pdf)
`Bridion (sugammadex)
`injection
`Labeling confusion
`- total strength
`expression on vial
`obscured by peel-
`off sticker intended
`for syringe
`Updated
`The Bridion applicant revised the peel-off label by moving it from the principal display panel to the side
`panel and vertically repositioned the barcode.
`Bridion (sugammadex)
`injection
`Laryngospasm
`Updated
`FDA decided that no action is necessary at this time based on available information.
`Bridion (sugammadex)
`injection
`Bronchospasm
`Updated
`FDA decided that no action is necessary at this time based on available information.
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`Product Name: Trade
`(Active Ingredient) or
`Product Class
`Potential Signal
`of a Serious Risk
`/ New Safety
`Information
`Additional Information
`(as of January 31, 2025)
`Carnitor
`(levocarnitine)
`injection
`Carnitor
`(levocarnitine) oral
`solution
`Carnitor
`(levocarnitine)tablets
`Carnitor SF
`(levocarnitine)
`sugar-free oral
`solution
`Hypersensitivity
`and anaphylaxis
`The “Warnings” and “Adverse Reactions” sections of labeling were updated to include hypersensitivity
`reactions.
`Carnitor labeling
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018948s028,019257s014lbl.pdf)
`Insulin Pen Products
`Apidra (insulin
`glulisine) injection
`Basaglar (insulin
`glargine) injection
`Fiasp (insulin
`aspart) injection
`Humulin (human
`isophane insulin and
`human insulin)
`injectable
`suspension
`Humalog (insulin
`lispro) injection
`Lantus (insulin
`glargine) injection
`Levemir (insulin
`detemir) injection
`Novolog (insulin
`aspart) injection
`Ryzodeg (insulin
`degludec and insulin
`aspart) injection
`Soliqua (insulin
`glargine and
`lixisenatide) injection
`Toujeo (insulin
`glargine) injection
`Tresiba (insulin
`degludec) injection
`Xultophy (insulin
`degludec and
`liraglutide) injection
`Product use error
`– failure to remove
`inner needle cover
`Updated
`An FDA Safety Communication was issued on
`September 27, 2018 (https://wayback.archive-
`it.org/7993/20201224130048/https:/www.fda.gov/medical-devices/safety-communications/caution-when-
`using-pen-needles-inject-medicines-fda-safety-communication)  (http://www.fda.gov/about-fda/website-
`policies/website-disclaimer), cautioning patients, caregivers, and health care providers when using pen
`needles to inject medicines.
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`Product Name: Trade
`(Active Ingredient) or
`Product Class
`Potential Signal
`of a Serious Risk
`/ New Safety
`Information
`Additional Information
`(as of January 31, 2025)
`Kinevac (sincalide) for
`injection
`Anaphylaxis,
`anaphylactic
`shock, and other
`hypersensitivity
`reactions
`The “Contraindications,” “Warnings,” and “Adverse Reactions” sections of labeling were updated to include
`anaphylaxis and hypersensitivity reactions.
`Kinevac labeling (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/017697s032lbl.pdf)
`Lamictal (lamotrigine)
`tablets
`Hemophagocytic
`lymphohistocytosis
`(HLH)
`The “Warnings and Precautions” section of labeling has been updated to include hemophagocytic
`lymphohistocytosis.
`Lamictal labeling (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020241s057lbl.pdf)
`Lamictal Drug Safety Communication (/drugs/drug-safety-and-availability/fda-drug-safety-communication-
`fda-warns-serious-immune-system-reaction-seizure-and-mental-health)
`(April 25, 2018) (/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-warns-serious-
`immune-system-reaction-seizure-and-mental-health)
`Ninlaro (ixazomib)
`capsules
`Product packaging
`quantity issues
`(empty unit dose
`blister cells)
`FDA decided that no action is necessary at this time based on available information.
`Noxafil
`(posaconazole)
`delayed-release
`tablets
`Noxafil
`(posaconazole)
`injection
`Noxafil
`(posaconazole) oral
`suspension
`Sporanox
`(itraconazole)
`capsules
`Sporanox
`(itraconazole)
`injection
`Mineralocorticoid
`excess Updated
`The “Adverse Reactions” section of the posaconazole labeling was updated in February 2019 to include
`pseudoaldosteronism.
`Noxafil labeling
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022003s025,205053s009,205596s008lbl.pdf)
`For itrazonazole, FDA decided that no action is necessary at this time based on available information.
`Propylthiouracil tablets Fatal cases of
`antineutrophil
`cytoplasmic
`antibody (ANCA)-
`associated
`vasculitis
`Updated
`The “Warnings,” “Precautions,” “Adverse Reactions,” and “Medication Guide” sections of the
`propylthiouracil labeling were updated in September 2018 to include vasculitis.
`Propylthiouracil labeling (https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/006188s026lbl.pdf)
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`Product Name: Trade
`(Active Ingredient) or
`Product Class
`Potential Signal
`of a Serious Risk
`/ New Safety
`Information
`Additional Information
`(as of January 31, 2025)
`Varubi (rolapitant)
`tablets
`Varubi (rolapitant)
`injectable emulsion,
`for intravenous use
`Infusion related
`and
`hypersensitivity
`reactions
`Updated
`The Varubi applicant issued a Dear Health Care Provider letter to inform health care providers of the
`potential risk of anaphylaxis, anaphylactic shock and other serious hypersensitivity reactions associated
`with use of Varubi (rolapitant) injectable emulsion.
`Dear Health Care Provider letter (/media/110258/download)
`The Varubi applicant notified FDA that Varubi injectable emulsion was no longer marketed and requested
`that approval of the Varubi injectable emulsion application be voluntarily withdrawn. FDA withdrew
`approval for Varubi in the Federal Register effective January 22, 2021.
`Withdrawal of Approval (https://www.regulations.gov/document/FDA-2020-N-2272-0001)
`Volumen (barium sulfate) Name confusion
`with Voluven
`(hydroxyethyl
`starch)
`Updated
`The Volumen manufacturer issued an information letter on February 14, 2018, to inform their customers of
`the potential risk of name confusion.
`The proprietary name was changed from Volumen to
`Neulumex
`(https://www.accessdata.fda.gov/spl/data/0c317cb8-036a-b89f-8049-0e4c38ceabd9/0c317cb8-036a-b89f-
`8049-0e4c38ceabd9.xml) to address the risk of name confusion.
`Yes
`No
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