Antibiotics, Antidepressants Dominate New FDA Watch List

Marcia Frellick

January 19, 2018

The latest quarterly watch list from the US Food and Drug Administration (FDA) includes 15 drugs or drug classes for which there is new safety information or possible signs of serious risk.

The watch list, updated January 12 on the FDA website, is created from the FDA Adverse Event Reporting System (FAERS).

Placement on this list does not mean the FDA has found that a drug is associated with the listed risk, only that the FDA has identified a potential safety problem. If a further review concludes that the drug is associated with the risk or causes a problem, the FDA has many options for further action, including requiring changes to labeling, restricting use of the drug, or, in rare cases, pulling a product from the market.

The current list, which is from the third quarter of 2017 (July-September), includes 11 antibiotics for which the FDA saw signs of potential risk for hypoglycemic coma and nine antidepressants the FDA flagged because of a potential risk for DRESS (drug reaction with eosinophilia and systemic symptoms).

For two drugs on the list, potential risk has resulted in changes to labels. Ibrutinib capsules (Imbruvica, Pharmacyclis Inc) were listed because of signs of potential risk for ventricular arrhythmia. The Warnings and Precautions section of the labeling for the drug has since been updated to include ventricular arrhythmia. For selexipag tablets (Uptravi, Actelion Phamaceuticals Ltd), the Adverse Reactions: Postmarketing Experience section of the labeling was updated to include hypotension.

For all but one of the other drugs listed, the FDA is evaluating whether regulatory action is needed. The exception is rivaroxaban tablets (Xarelto, Janssen Pharmaceuticals), for which the FDA has determined there is no need for action at this time.

Table.

Active Ingredient (Trade Name) or Product Class Potential Signal of a Serious Risk/New Safety Information Additional Information (as of January 12, 2018)
Tocilizumab injection (Actemra), for intravenous or subcutaneous use. Pancreatitis, hepatotoxicity FDA is evaluating the need for regulatory action.
  • Fenofibrate capsules (Antara)

  • Fenofibrate tablets (Fenoglide, Tricor, Triglide)

  • Fenofibrate capsules, USP (Lipofen)

  • Fenofibric acid tablets (Fibricor)

  • Fenofibric acid capsules, delayed release (Trilipix)

Serious skin reactions FDA is evaluating the need for regulatory action.
  • Amitriptyline

  • Bupropion

  • Citalopram

  • Duloxetine

  • Escitalopram

  • Fluoxetine

  • Paroxetine

  • Sertraline

  • Venlafaxine

DRESS (drug reaction with eosinophilia and systemic symptoms) FDA is evaluating the need for regulatory action.
  • Moxifloxacin hydrochloride injection (Avelox), for intravenous use

  • Moxifloxacin hydrochloride tablets (Avelox)

  • Ciprofloxacin hydrochloride oral suspension (Cipro)

  • Ciprofloxacin injection (Cipro IV), for intravenous use

  • Ciprofloxacin hydrochloride tablets (Cipro)

  • Ciprofloxacin extended-release tablets (Cipro XR)

  • Gemifloxacin mesylate tablets (Factive)

  • Levofloxacin injection (Levaquin), solution for intravenous use

  • Levofloxacin (Levaquin), solution for oral use

  • Levofloxacin tablets (Levaquin), film coated for oral use

  • Moxifloxacin injection, for intravenous use

Hypoglycemic coma FDA is evaluating the need for regulatory action.
  • Cetirizine hydrochloride

  • Levocetirizine dihydrochloride

  • Pseudoephedrine hydrochloride

Rebound pruritis FDA is evaluating the need for regulatory action.
Pseudoephedrine Acute generalized exanthematous pustulosis FDA is evaluating the need for regulatory action.
Ibrutinib capsules (Imbruvica) Hepatotoxicity and ventricular arrhythmia Regarding hepatotoxicity, FDA is evaluating the need for regulatory action. Regarding ventricular arrhythmia, the Warnings and Precautions section of the labeling was updated to include ventricular arrhythmia.
  • Methotrexate injection, USP

  • Methotrexate oral solution (Xatmep)

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 Acute renal failure FDA is evaluating the need for regulatory action.
Obeticholic acid tablets (Ocaliva), 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 administration) FDA is evaluating the need for regulatory action.
Eculizumab injection (Soliris), for intravenous use Nongroupable meningitis infections and Neisseria (other than N. meningitides) infections FDA is evaluating the need for regulatory action.
Selexipag tablets (Uptravi) Hypotension The Adverse Reactions: Postmarketing Experience section of the labeling was updated to include hypotension.
Cariprazine capsules (Vraylar) Stevens-Johnson syndrome FDA is evaluating the need for regulatory action.
Rivaroxaban tablets (Xarelto) Liver injury FDA decided on the basis of available information that no action is necessary at this time.
Source: FDA

More information about FAERS and its quarterly watch lists is available on the FDA website.

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