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 April 16, 2020)
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. Calcium gluconate labeling
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.	Updated The “Warnings and Precautions” and “Adverse Reactions” sections of the labeling for TachoSil were updated to include information about gastrointestinal obstruction. TachoSil (thrombin human and fibrinogen) patch labeling
Visipaque (iodixanol) injection	Hypersensitivity	FDA decided that no action is necessary at this time.