Drugs

Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS): January - March 2018

Product Name: Trade (Active Ingredient) or Product Class

Potential Signal of a Serious Risk / New Safety Information

Additional Information
(as of July 10, 2018)

  • 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

FDA is evaluating the need for regulatory action.

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.

Volumen (barium sulfate)

Name confusion with Voluven (hydroxyethyl starch)

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

FDA is evaluating the need for regulatory action.

Bridion (sugammadex) injection

Labeling confusion - total strength expression on vial obscured by peel-off sticker intended for syringe

FDA is evaluating the need for regulatory action.

Bridion (sugammadex) injection

Laryngospasm

FDA is evaluating the need for regulatory action.

Bridion (sugammadex) injection

Bronchospasm

FDA is evaluating the need for regulatory action.

  • 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

FDA is evaluating the need for regulatory action.

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

FDA is evaluating the need for regulatory action.

Propylthiouracil tablets

Fatal cases of antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis

FDA is evaluating the need for regulatory action.

  • Varubi (rolapitant) tablets
  • Varubi (rolapitant) injectable emulsion, for intravenous use

Infusion related and hypersensitivity reactions

FDA is evaluating the need for regulatory action.

 

Page Last Updated: 07/12/2018
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