Drugs

Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS): January - March 2017

Product Name: Trade (Active Ingredient) or Product Class

Potential Signal of a Serious Risk / New Safety Information

Additional Information
(as of June 30, 2017)

  • Alli (orlistat) capsules
  • Xenical (orlistat) capsules, for oral use

Orlistat and neuropsychiatric adverse events

FDA is evaluating the need for regulatory action.

  • Cubicin (daptomycin for injection) for intravenous use
  • Cubicin RF (daptomycin for injection) for intravenous use

Medication error

The container labels and carton labeling were revised.  In addition, the “Dosage and Administration” section of the labeling was updated to better differentiate the two formulations.

Cubicin labeling

Cubicin RF labeling

  • Exjade (deferasirox) tablets, for oral suspension
  • Jadenu (deferasirox) tablets, for oral use

Pediatric fever and dehydration

FDA is evaluating the need for regulatory action.

Gonadotropin-releasing hormone (GnRH) Agonists

  • Lupron (leuprolide acetate) injection
  • Lupron Depot PED (leuprolide acetate for depot suspension), injection, powder, lyophilized, for suspension
  • Supprelin LA (histrelin acetate) subcutaneous implant
  • Synarel (nafarelin acetate) nasal solution

Musculoskeletal and connective tissue pain and discomfort

FDA is evaluating the need for regulatory action.

  • Keppra (levetiracetam) tablets, for oral use
  • Keppra (levetiracetam) extended-release tablets, for oral use
  • Keppra (levetiracetam) oral solution
  • Keppra (levetiracetam) injection, for intravenous use

Acute kidney injury and interstitial nephritis

The “Adverse Reactions; Postmarketing Experience” section of the labeling for Keppra and Keppra XR was updated to include acute kidney injury.

Keppra XR labeling

Keppra labeling (tablets & oral solution)

Keppra labeling (injection)
  • Keytruda (pembrolizumab) for injection, for intravenous use
  • Opdivo (nivolumab) injection, for intravenous use
  • Yervoy (ipilimumab) injection, for intravenous use

Ocular toxicities including vision loss and retinal detachment

FDA is evaluating the need for regulatory action.

Kybella (deoxycholic acid) injection, for subcutaneous use

Injection site infection and necrosis

FDA is evaluating the need for regulatory action.

Methimazole tablets

Rhabdomyolysis in methimazole

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

Neulasta Onpro kit (pegfilgrastim) injection, for subcutaneous use

Device failure

FDA is evaluating the need for regulatory action.

Ofev (nintedanib) capsules, for oral use

Liver dysfunction

FDA is evaluating the need for regulatory action.

Sodium-glucose cotransporter-2 (SGLT-2) inhibitors

  • Farxiga (dapagliflozin) tablets, for oral use
  • Glyxambi (empagliflozin and linagliptin) tablets, for oral use
  • Invokamet (canagliflozin and metformin hydrochloride) tablets, for oral use
  • Invokamet XR (canagliflozin and metformin hydrochloride extended-release) tablets, for oral use
  • Invokana (canagliflozin) tablets, for oral use
  • Jardiance (empagliflozin) tablets, for oral use
  • Synjardy (empagliflozin and metformin hydrochloride) tablets, for oral use
  • Synjardy XR (empagliflozin and metformin hydrochloride extended-release) tablets, for oral use
  • Xigduo XR (dapagliflozin and metformin hydrochloride extended-release) tablets, for oral use

Nephrolithiasis

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

Stelara (ustekinumab) injection, for subcutaneous use

Interstitial pneumonia

FDA is evaluating the need for regulatory action.

  • Tanzeum (albiglutide) for injection, for subcutaneous use
  • Trulicity (dulaglutide), injection, for subcutaneous use

Serious hypersensitivity reactions

FDA is evaluating the need for regulatory action.

Uloric (febuxostat) tablets, for oral use

Drug reaction with Eosinophilia and Systemic Symptoms

FDA is evaluating the need for regulatory action.

 

 

 

Page Last Updated: 06/30/2017
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