Drugs

Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS): July - September 2017

Product Name: Trade (Active Ingredient) or Product Class

Potential Signal of a Serious Risk / New Safety Information

Additional Information
(as of January 12, 2018)

Actemra (tocilizumab) injection, for intravenous and subcutaneous use

Tocilizumab and pancreatitis

FDA is evaluating the need for regulatory action.

Actemra (tocilizumab) injection, for intravenous or subcutaneous use

Tocilizumab and hepatotoxicity

FDA is evaluating the need for regulatory action.

  • Antara (fenofibrate) capsules, for oral use
  • Fenoglide (fenofibrate) tablets, for oral use
  • Fibricor (fenofibric acid) tablets, for oral use
  • Lipofen (fenofibrate capsules, USP) for oral use
  • Tricor (fenofibrate) tablet, for oral use
  • Triglide (fenofibrate) tablets, for oral use
  • Trilipix (fenofibric acid) capsule, delayed release for oral use

Serious skin reactions

FDA is evaluating the need for regulatory action.

  • amitriptyline        
  • bupropion        
  • citalopram        
  • duloxetine        
  • escitalopram        
  • fluoxetine        
  • paroxetine        
  • sertraline        
  • venlafaxine         

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)

FDA is evaluating the need for regulatory action.

  • Avelox (moxifloxacin hydrochloride) injection, for intravenous use
  • Avelox (moxifloxacin hydrochloride) tablets, for oral use
  • Cipro (ciprofloxacin hydrochloride), for oral suspension
  • Cipro IV (ciprofloxacin) injection, for intravenous use
  • Cipro (ciprofloxacin hydrochloride) tablet, for oral use
  • Cipro XR (ciprofloxacin) extended-release tablets, for oral use
  • Factive (gemifloxacin mesylate) tablets
  • Levaquin (levofloxacin) injection, solution for intravenous use
  • Levaquin (levofloxacin), solution for oral use
  • Levaquin (levofloxacin) tablet, film coated for oral use
  • Moxifloxacin injection, for intravenous use

Hypoglycemic coma

FDA is evaluating the need for regulatory action.

  • Cetirizine hydrochloride
  • Hydroxyzine
  • Levocetirizine dihydrochloride

Rebound Pruritis

FDA is evaluating the need for regulatory action.

Pseudoephedrine

Acute generalized exanthematous pustulosis

FDA is evaluating the need for regulatory action.

Imbruvica (ibrutinib) capsules, for oral use

Hepatotoxicity

FDA is evaluating the need for regulatory action.

Imbruvica (ibrutinib) capsules, for oral use

Ventricular arrhythmia

The “Warnings and Precautions” section of the labeling for Imbruvica was updated to include ventricular arrhythmia.

Imbruvica labeling

  • Methotrexate injection, USP
  • Xatmep (methotrexate) oral solution

Drug interaction with nitrous oxide - potentiated effect of methotrexate on folate metabolism, resulting in increased toxicity (severe myelosuppression, stomatitis, and neurotoxicity)

FDA is evaluating the need for regulatory action.

Nafcillin Injection, USP, for intravenous use only

Acute renal failure

FDA is evaluating the need for regulatory action.

Ocaliva (obeticholic acid) tablets, for oral use

Liver injury

FDA is evaluating the need for regulatory action.

  • Rheumatrex (methotrexate sodium) tablets
  • Methotrexate tablets, USP

Wrong dosing frequency errors (once daily administration instead of intended once weekly schedule)

FDA is evaluating the need for regulatory action.

Soliris (eculizumab) injection, for intravenous use

Nongroupable meningitis infections and Neisseria (other than N. meningitides) infections

FDA is evaluating the need for regulatory action.

Uptravi (selexipag) tablets, for oral use

Hypotension

The “Adverse Reactions: Postmarketing Experience” section of the labeling for Uptravi was updated to include hypotension.

Uptravi labeling

Vraylar (cariprazine) capsules, for oral use

Stevens-Johnson syndrome (SJS)

FDA is evaluating the need for regulatory action.

Xarelto (rivaroxaban) tablets, for oral use

Liver injury

FDA decided that no action is necessary at this time based on available information.

 

Page Last Updated: 05/17/2018
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