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  6. Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS): October - December 2017
  1. Surveillance: Post Drug-Approval Activities

Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS): October - December 2017

Product Name: Trade (Active Ingredient) or Product Class

Potential Signal of a Serious Risk / New Safety Information

Additional Information
(as of April 27, 2018)

  • 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

FDA is evaluating the need for regulatory action.

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

FDA is evaluating the need for regulatory action.

  • 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

FDA is evaluating the need for regulatory action

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)

FDA is evaluating the need for regulatory action.

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

FDA is evaluating the need for regulatory action.

ProvayBlue (methylene blue) injection

Inappropriate dilution of medication

FDA is evaluating the need for regulatory action.

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

FDA is evaluating the need for regulatory action.

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