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  6. April - June 2019 | 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)

April - June 2019 | 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 September 18, 2019)
  • Bactrim DS (sulfamethoxazole and trimethoprim)
  • Septra (sulfamethoxazole and trimethoprim)
  • Generic products containing sulfamethoxazole and trimethoprim
Hypersensitivity/Acute respiratory failure  FDA is evaluating the need for regulatory action.
Fasenra (benralizumab)   Flu-like illness FDA is evaluating the need for regulatory action.
Fasenra (benralizumab) Herpes zoster FDA is evaluating the need for regulatory action.
  • Feraheme (ferumoxytol)
  • Ferrlecit (sodium ferric gluconate)
  • INFeD (iron dextran)
  • Injectafer (ferric carboxymaltose)
  • Venofer (iron sucrose)
  • Generic products containing sodium ferric gluconate
Fetal death FDA is evaluating the need for regulatory action.
Gamunex-C [Immune Globulin (Human), 10% Caprylate/Chromatography Purified] Increased hypersensitivity reactions in patients receiving certain product lots FDA is evaluating the need for regulatory action
  • Gilenya (fingolimod)
Tumefactive multiple sclerosis FDA is evaluating the need for regulatory action.
  • Gilenya (fingolimod)
Thrombocytopenia FDA is evaluating the need for regulatory action.
HMG-CoA reductase inhibitors
  • Altoprev (lovastatin)
  • Caduet (amlodipine besylate and atorvastatin calcium)
  • Crestor (rosuvastatin calcium)
  • Ezallor (rosuvastatin)
  • Lescol (fluvastatin sodium)
  • Lescol XL (fluvastatin sodium)
  • Liptruzet (atorvastatin and ezetimibe)
  • Livalo (pitavastatin)
  • Pitavastatin
  • Pravachol (pravastatin sodium)
  • Zocor (simvastatin)
  • Zypitamag (pitavastatin magnesium )
  • Generic products containing HMG-CoA reductase inhibitors
Immune-mediated necrotising myopathy FDA is evaluating the need for regulatory action.
Increlex (mecasermin) Malignancies FDA is evaluating the need for regulatory action.
  • Livalo (pitavastatin)
  • Zypitamag (pitavastatin  magnesium )
Drug hypersensitivity FDA is evaluating the need for regulatory action.
Mavyret (glecaprevir and pibrentasvir) Hypersensitivity: angioedema and anaphylaxis FDA is evaluating the need for regulatory action
Ninlaro (ixazomib)   Thrombotic microangiopathy (TMA) FDA is evaluating the need for regulatory action.
  • Nipent (pentostatin)
  • Generic products containing pentostatin
Thrombotic microangiopathy (TMA) FDA is evaluating the need for regulatory action.
  • Onfi (clobazam)
  • Generic products containing clobazam
Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) FDA is evaluating the need for regulatory action.
Orencia (abatacept) Angioedema FDA is evaluating the need for regulatory action.
Orbactiv (oritavancin diphosphate) Anaphylaxis FDA is evaluating the need for regulatory action.
  • Sensipar (cinacalcet hydrochloride)
  • Generic products containing cinacalcet hydrochloride
Chondrocalcinosis pyrophosphate FDA is evaluating the need for regulatory action.
Tecfidera (dimethyl fumarate) Serious herpes infection FDA is evaluating the need for regulatory action.
  • Udeynca (pegfilgrastim, CHS-1701)
  • Xgeva (denosumab)
Medication error – Labeling confusion (wrong drug errors) FDA is evaluating the need for regulatory action.
Velphoro (sucroferric oxyhydroxide) Hemoglobin increased FDA is evaluating the need for regulatory action.
Vivitrol (naltrexone hydrochloride)  Medication Error - Patient self-administration errors The carton labeling, sections of the product labeling (“Dosage and Administration”, “Warnings and Precautions,” “Adverse Reactions,” “How Supplied/Storage and Handling,” and “Patient Counseling”), and the Medication Guide, were updated to emphasize that Vivitrol must be injected by a healthcare provider.
Vivitrol labeling
Xofluza (baloxavir marboxil) Anaphylaxis and angioedema FDA is evaluating the need for regulatory action.
Xofluza (baloxavir marboxil) Medication error - Labeling confusion (wrong dose errors) FDA is evaluating the need for regulatory action
Yondelis (trabectedin) Interstitial lung disease and mucositis FDA is evaluating the need for regulatory action