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FDA Flags 14 Drugs in New Watch List


The U.S. Food and Drug Administration (FDA) has added 14 drugs or drug classes to a watch list of drugs flagged for potentially serious adverse events.

Purpose of the FDA Watch List

According to Medscape, the watch list was created to reflect “potential signals of serious risk or new safety information” gathered from reports made through the FDA Adverse Event Reporting System (FAERS).

Once a drug is placed on the list, the FDA evaluates the drug to determine if there is a causal relationship between the drug and adverse events reported. If a causal link is observed, the FDA can order further regulatory action or remove the product from the market completely.

The latest watch list is based on possible safety issues noted by the FDA during the first three months of 2017 and includes actions taken by the FDA as of June 30, 2017.

Drugs Included on the FDA Watch List

  • Alli (orlestat), Xenical (orlistat):
    • Reason for Inclusion: Possible neuropsychiatric adverse events
    • Action Taken (as of June 30, 2017): FDA is Evaluating the need for regulatory action
  • Cubicin/Cubicin RF (daptomycin for injection)
    • Reason for Inclusion: Potential medication error
    • Action Taken (as of June 30, 2017): Container labels and carton labeling revised
  • Exjade (deferasirox), Jadenu (deferasirox):
    • Reason for Inclusion: Pediatric fever and dehydration
    • Action Taken (as of June 30, 2017): FDA is Evaluating the need for regulatory action
  • Lupron (leuprolide acetate), Supprelin LA (histrelin acetate), Synarel (nafarelin acetate)
    • Reason for Inclusion: Musculoskeletal and connective tissue pain and discomfort
    • Action Taken (as of June 30, 2017): FDA is Evaluating the need for regulatory action
  • Keppra/Keppra XR (levetiracetam) – tablets, extended-release tablets, injection, and oral solution
    • Reason for Inclusion: Acute kidney injury and interstitial nephritis
    • Action Taken (as of June 30, 2017): “Adverse Reactions: Postmarketing Experience” section updated to include acute kidney injury.
  • Keytruda (pembrolizumab), Opdivo (hivolumab), Yervoy (ipilimumab)
    • Reason for Inclusion: Ocular toxicities, including vision loss and retinal detachment
    • Action Taken (as of June 30, 2017): FDA is Evaluating the need for regulatory action
  • Kybella (deoxycholic acid):
    • Reason for Inclusion: Injection site infection and necrosis
    • Action Taken (as of June 30, 2017): FDA is Evaluating the need for regulatory action
  • Methimazole tablets:
    • Reason for Inclusion: Rhabdomyolysis in methimazole
    • Action Taken (as of June 30, 2017): FDA decided that no action is necessary at this time
  • Neulasta Onpro kit (pegfilgrastim):
    • Reason for Inclusion: Device gailure
    • Action Taken (as of June 30, 2017): FDA is Evaluating the need for regulatory action
  • Ofev (nintedanib):
    • Reason for Inclusion: Liver dysfunction
    • Action Taken (as of June 30, 2017): FDA is evaluating the need for regulatory action
  • SGLT-2 inhibitors
    • Reason for Inclusion: Nephrolithiasis
    • Action Taken (as of June 30, 2017): FDA decided that no action is necessary at this time
  • Stelara (ustekinumab):
    • Reason for Inclusion: Interstitial pneumonia
    • Action Taken (as of June 30, 2017): FDA is Evaluating the need for regulatory action
  • Tanzeum (albigulutide), Trulicity (dulaglutide):
    • Reason for Inclusion: Pserious hypersensitivity reaction
    • Action Taken (as of June 30, 2017): FDA is Evaluating the need for regulatory action
  • Uloric (febuxostat):
    • Reason for Inclusion: Drug reaction with eosinophilia and systemic symptoms
    • Action Taken (as of June 30, 2017): FDA is Evaluating the need for regulatory action

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