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 December 13, 2022)
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.
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	FDA is evaluating the need for regulatory action.
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
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.
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
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, cautioning patients, caregivers, and health care providers when using pen needles to inject medicines.
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
Lamictal (lamotrigine) tablets	Hemophagocytic lymphohistocytosis (HLH)	The “Warnings and Precautions” section of labeling has been updated to include hemophagocytic lymphohistocytosis. Lamictal labeling Lamictal Drug Safety Communication (April 25, 2018)
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 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
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 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
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 to address the risk of name confusion.