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  5. Questions and Answers on FDA's Adverse Event Reporting System (FAERS)
  6. January - March 2017 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
  1. Questions and Answers on FDA's Adverse Event Reporting System (FAERS)

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

Product Name: Trade (Active Ingredient) or Product Class

Potential Signal of a Serious Risk / New Safety Information

Additional Information
(as of December 13, 2022)

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

Orlistat and neuropsychiatric adverse events

Updated

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

  • 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

Updated

The “Pediatric Use” and “Patient Counseling Information” sections of the Exjade and Jadenu labeling were updated in May 2018 to include pediatric fever and dehydration.

Exjade labeling

Jadenu labeling

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

Updated

The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Information” sections of the Kybella labeling were updated in January 2018 to include injection site infection and necrosis.

Kybella labeling

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

Updated

The “Warnings and Precautions” section of the Neulasta Onpro kit labeling was updated in December 2017 to include device failure.

Neulasta Onpro kit labeling

Ofev (nintedanib) capsules, for oral use

Liver dysfunction

Updated

The “Warnings and Precautions” and “Adverse Reactions” sections of the Ofev labeling were updated in August 2017 to include liver dysfunction.

Ofev labeling

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

Updated

The “Warnings and Precautions” and “Adverse Reactions” sections of the Stelara labeling were updated in June 2018 to include interstitial pneumonia.

Stelara labeling

 

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

Serious hypersensitivity reactions

Updated

The “Contraindications”, “Warnings and Precautions”, “Adverse Reactions”, “Medication Guide”, and “Patient Counseling Information” sections of the Tanzeum and Trulicity labeling were updated in August 2017 to include serious hypersensitivity reactions.

Tanzeum labeling

Trulicity labeling

Uloric (febuxostat) tablets, for oral use

Drug reaction with Eosinophilia and Systemic Symptoms

Updated

The “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information”, and “Patient Information” sections of the Uloric labeling were updated in February 2018 to include serious skin reactions.

Uloric labeling

 

 

 

 
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