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  5. Questions and Answers on FDA's Adverse Event Reporting System (FAERS)
  6. October - December 2015 | 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)

October - December 2015 | 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 August 26, 2019)
Calcium gluconate injection
Potential for wrong drug error
The container labels for calcium gluconate were revised to better differentiate the product from sterile water for injection.
Epinephrine auto-injectors
Clostridium perfringens infection
Updated

The Warnings and Precautions section of the epinephrine injection labeling was updated in May 2016 to include the risk of Clostridium perfringens infection.

Epipen label

Epipen (epinephrine) injection
 
Epipen Jr (epinephrine) injection
Lacerations and embedded needles
Updated

The Dosage and Administration and Warnings and Precautions sections of the epinephrine injection labeling was updated in May 2016 to include the risk of lacerations and embedded needles.

Epipen label

Harvoni (ledipasvir/sofosbuvir) tablet
 
Olysio (simeprevir) capsule
 
Sovaldi (sofosbuvir) tablet
Rhabdomyolysis
Updated

The Drug Interactions section of the Olysio labeling was updated in May 2017 and the Drug Interactions section of the Harvoni labeling was updated in November 2017 to include the risk of rhabdomyolysis.  

Harvoni label

Olysio label

Iodinated contrast agents (numerous products)
Myasthenia gravis exacerbation
Updated
FDA decided that no action is necessary at this time based on available information.
Keppra (levetiracetam) tablet, oral solution, injection
 
Spritam (levetiracetam) tablet (for suspension)
Angioedema
 
Anaphylaxis
 
Updated
The Contraindications, Warnings and Precautions, Adverse Reactions, Patient Counseling Information and the Medication Guide sections of the levetiracetam  labeling were updated from April 2017 to June 2017 to include the risk of anaphylaxis and angioedema.
 
Keppra label
SGLT2 inhibitors:
  • Farxiga (dapagliflozin) tablet
  • Glyxambi (empagliflozin/linagliptin) tablet
  • Jardiance (empagliflozin) tablet
  • Invokamet (canagliflozin/metformin HCl) tablet
  • Invokana (canagliflozin) tablet
  • Synjardy (empagliflozin/metformin HCl) tablets
  • Xigduo XR (dapagliflozin/metformin HCl) extended release tablet
Acute kidney injury
Updated

The Dosage and Administration, Contraindications, Warnings and Precautions, and/or Adverse Reactions sections of the SGLT2 inhibitor product labeling were updated from May 2016 to December 2016, to include the risk of acute kidney injury.

Farxiga label

Glyxambi label 

Jardiance label

Invokamet label

Invokana label 

Synjardy label  

Xigduo XR label

Somatostatin analogs:
  • Sandostatin (octreotide acetate) injection
  • Sandostatin LAR Depot (octreotide acetate) for injectable suspension
  • Somatuline Depot (lanreotide) injection
  • Signifor (pasireotide) injection
  • Signifor LAR (pasireotide) injection
Cholecystitis

Updated

The Warnings and Precautions, Adverse Reactions, Patient Counseling Information and/or Information for Patients sections of the somatostatin analog product labeling were updated in April 2019 to include the risk of complications of cholelithiasis (e.g., cholecystitis, cholangitis and pancreatitis).

Sandostatin label

Sandostatin LAR Depot label 

Somatuline Depot label 

Signifor label 

Signifor LAR label 

TachoSil (fibrin sealant patch)
Intestinal obstruction in patients undergoing abdominal and/or pelvic surgery.
FDA is evaluating the need for regulatory action.
Visipaque (iodixanol) injection
Hypersensitivity
FDA decided that no action is necessary at this time.