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  4. Surveillance: Post Drug-Approval Activities
  5. Questions and Answers on FDA's Adverse Event Reporting System (FAERS)
  6. January - March 2018 | Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS)
  1. Questions and Answers on FDA's Adverse Event Reporting System (FAERS)

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.

 

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