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  6. October - December 2017 | Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS)
  1. FDA's Adverse Event Reporting System (FAERS)

October - December 2017 | Potential Signals of Serious Risks/New Safety Information Identified from 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)

  • Asclera (polidocanol) injection
  • Sotradecol (sodium tetradecyl sulfate) injection
  • Varithena (polidocanol) injectable foam

Cardiovascular adverse events

For Asclera and Sotradecol, the “Warnings and Precautions” section of labeling was updated to include the risk of arterial embolism.

Asclera labeling

Sotradecol labeling

No regulatory action was warranted for Varithena.

Cytotec (misoprostol) tablets

High fevers (greater than 104 degrees Fahrenheit or 40 degrees Celsius)

The “Precautions” section of labeling was updated to include high fevers greater than 104 degrees Fahrenheit or 40 degrees Celsius.

Cytotec labeling

Emend (fosaprepitant) for injection

Infusion site reactions

Updated

The “Highlights”, “Warnings and Precautions”, and “Patient Counseling Information” sections of the Emend labeling were updated in March 2018 to include infusion site reactions.

Emend labeling

Erythrocin Lactobionate – IV (erythromycin lactobionate) for injection

Drug interaction with HMG-CoA reductase inhibitors (lovastatin and simvastatin) extensively metabolized by CYP3A4 (enzyme) resulting in myopathy and rhabdomyolysis

Updated

The “Contraindications” section of the Erythrocin labeling was updated in April 2018 to contraindicate concomitant use of lovastatin and simvastatin.

Erythrocin Lactobionate – IV labeling

  • Fortamet (metformin hydrochloride) extended-release tablets
  • Glucophage (metformin hydrochloride) tablets
  • Glucophage XR (metformin hydrochloride) extended-release tablets
  • Glumetza (metformin hydrochloride) extended-release tablets
  • Riomet (metformin hydrochloride) oral solution

Serious skin reactions

Updated

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

Lamictal (lamotrigine) tablets

Labetalol-lamotrigine name confusion/medication errors associated with serious outcomes

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

Lexiscan (regadenoson) injection

Serious cardiac adverse events following prolonged Lexiscan administration (>10 seconds)

Updated

The “Dosage and Administration” and “Warnings and Precautions” sections of the Lexiscan labeling were updated in May 2018 to reinforce adherence to the recommended duration of injection.

Lexiscan labeling

Muscle Relaxants

  • Amrix (cyclobenzaprine hydrochloride) extended release capsules
  • Equagesic (aspirin and meprobamate) tablets
  • Maolate (chlorphenesin carbamate) tablets
  • Metaxalone Tablets (metaxalone) tablets
  • Norflex (orphenadrine citrate) extended release tablets
  • Norflex (orphenadrine citrate) injection
  • Norgesic (aspirin, caffeine, orphenadrine citrate) tablets
  • Parafon Forte DSC (chlorzoxazone) tablets
  • Robaxin (methocarbamol) injection
  • Robaxin (methocarbamol) tablets
  • Skelaxin (metaxalone) tablets
  • Soma (carisoprodol) tablets

Serotonin syndrome

Updated

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

ProvayBlue (methylene blue) injection

Inappropriate dilution of medication

Updated

The carton and container labels of ProvayBlue were updated in May 2018 to clarify the appropriate solution for dilution.

ProvayBlue labeling

Singulair (montelukast sodium) tablets

Neuropsychiatric adverse reactions

FDA is evaluating the need for regulatory action.

Sodium-Glucose Cotransporter-2 (SGLT-2) Inhibitors

  • Farxiga (dapagliflozin) tablets
  • Glyxambi (empagliflozin and linagliptin) tablets
  • Invokana (canagliflozin) tablets
  • Invokamet (canagliflozin and metformin hydrochloride) tablets
  • Invokamet XR (canagliflozin and metformin hydrochloride extended-release) tablets
  • Jardiance (empagliflozin) tablets
  • Qtern (dapagliflozin and saxagliptin) tablets
  • Synjardy (empagliflozin and metformin hydrochloride) tablets
  • Synjardy XR (empagliflozin and metformin hydrochloride extended-release) tablets
  • Xigduo XR (dapagliflozin and metformin hydrochloride extended-release) tablets

Fournier’s gangrene

Updated

The “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information” and “Medication Guide” sections of the SGLT-2 inhibitor product labeling were updated in October 2018 to include necrotizing fasciitis of the perineum (Fournier’s gangrene).

Example: Farxiga labeling

Viberzi (eluxadoline) tablets

Anaphylaxis and hypersensitivity

The “Warnings and Precautions” and the “Adverse Reactions” sections of labeling were updated to include hypersensitivity.  The Medication Guide was updated to include serious allergic reactions.

Viberzi labeling

 

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