Drugs

Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) between October - December 2015

Product Name: Trade (Active Ingredient) or Product Class
Potential Signal of a Serious Risk / New Safety Information
Additional Information
(as of March 31, 2016)
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
FDA is evaluating the need for regulatory action.
Epipen (epinephrine) injection
 
Epipen Jr (epinephrine) injection
Lacerations and embedded needles
FDA is evaluating the need for regulatory action.
Harvoni (ledipasvir/sofosbuvir) tablet
 
Olysio (simeprevir) capsule
 
Sovaldi (sofosbuvir) tablet
Rhabdomyolysis
FDA is evaluating the need for regulatory action.
Iodinated contrast agents (numerous products)
Myasthenia gravis exacerbation
FDA is evaluating the need for regulatory action.
Keppra (levetiracetam) tablet, oral solution, injection
 
Spritam (levetiracetam) tablet (for suspension)
Angioedema
 
Anaphylaxis
FDA is evaluating the need for regulatory action.
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
FDA is evaluating the need for regulatory action.
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
FDA is evaluating the need for regulatory action.
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.

 

Page Last Updated: 08/02/2016
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