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  6. October - December 2018 | 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 2018 | 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 25, 2019)

Aimovig (erenumab-aooe) injection

Hypersensitivity events

The “Contraindications” and “Warnings and Precautions” sections of the labeling were updated to include information about hypersensitivity reactions.
Aimovig labeling

  • Abilify (aripiprazole)
  • Abilify Discmelt (aripiprazole) tablet
  • Abilify Maintena (aripiprazole) injection
  • Abilify MyCite (aripiprazole tablets with sensor) tablet
  • Aristada (aripiprazole lauroxil)
  • Generic products containing aripiprazole

Acute generalized exanthematous pustulosis, Drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome, and toxic epidermal necrolysis

FDA is evaluating the need for regulatory action.

  • Anoro Ellipta (umeclidinium and vilanterol)
  • Arnuity Ellipta (fluticasone furoate)
  • Breo Ellipta (fluticasone furoate and vilanterol)
  • Incruse Ellipta (umeclidinium)
  • Trelegy Ellipta (fluticasone furoate, vilanterol, and umeclidinium)

Medication errors: wrong drug

FDA is evaluating the need for regulatory action.

  • Antara (fenofibrate) capsule
  • Fenoglide (fenofibrate) tablet
  • Fibricor (fenofibric acid) tablet
  • Lipofen (fenofibrate) capsule
  • TriCor (fenofibrate) tablet
  • TriCor NFE (fenofibrate) tablet
  • Triglide (fenofibrate) tablet
  • Trilipix (fenofibric acid) capsule
  • Generic products containing fenofibrate

Interstitial lung disease

FDA is evaluating the need for regulatory action.

  • Belbuca (buprenorphine hydrochloride) film
  • Bunavail (buprenorphine hydrochloride and naloxone hydrochloride) film
  • Cassipa (buprenorphine hydrochloride and naloxone hydrochloride) film
  • Suboxone (buprenorphine and naloxone) tablet
  • Suboxone (buprenorphine and naloxone) film
  • Subutex (buprenorphine hydrochloride) tablet
  • Zubsolv (buprenorphine hydrochloride and naloxone hydrochloride) tablet
  • Generic oral products containing buprenorphine hydrochloride or buprenorphine hydrochloride and naloxone hydrochloride

Drug-induced dental caries

FDA is evaluating the need for regulatory action.

Bosulif (bosutinib monohydrate) film

Cardiac failure

FDA is evaluating the need for regulatory action.

Chlorpromazine hydrochloride

Drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome, and toxic epidermal necrolysis

FDA is evaluating the need for regulatory action.

Cinvanti (aprepitant) injection

Hypersensitivity reactions, including anaphylaxis

The “Contraindications” and “Warnings and Precautions” sections of the labeling were updated to reflect information about hypersensitivity reactions.

Cinvanti labeling

  • Clozaril (clozapine) tablet
  • FazaClo ODT (clozapine) tablet
  • Versacloz (clozapine) suspension
  • Generic products containing clozapine

Stevens-Johnson syndrome and toxic epidermal necrolysis

FDA decided that no action is necessary at this time.

Gilenya (fingolimod) capsule

Hemolytic anemia

FDA is evaluating the need for regulatory action.

  • Gralise (gabapentin) tablet
  • Horizant (gabapentin encarbil) tablet
  • Lyrica (pregabalin) capsule
  • Lyrica (pregabalin) solution
  • Lyrica CR (pregabalin) tablet
  • Neurontin (gabapentin)
  • Generic products containing gabapentin or pregabalin

Respiratory depression

FDA is evaluating the need for regulatory action.

  • Gralise (gabapentin) tablet
  • Horizant (gabapentin encarbil) tablet
  • Lyrica (pregabalin) capsule
  • Lyrica (pregabalin) solution
  • Lyrica CR (pregabalin) tablet
  • Neurontin (gabapentin)
  • Generic products containing gabapentin or pregabalin

Bullous pemphigoid

FDA is evaluating the need for regulatory action.

  • Haldol (haloperidol) injection
  • Haldol (haloperidol) decanoate injection
  • Haloperidol injection

Acute generalized exanthematous pustulosis, Drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome, and toxic epidermal necrolysis

FDA is evaluating the need for regulatory action.

  • Inlyta (axitinib) tablet
  • Coumadin (warfarin sodium) tablet
  • Generic products containing warfarin sodium

 

Drug interaction between axitinib and warfarin

FDA is evaluating the need for regulatory action.

  • Invega (paliperidone) tablet
  • Invega Sustenna (paliperidone palmitate) suspension
  • Invega Trinza (paliperidone)
  • Generic products containing paliperidone

Drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome, and toxic epidermal necrolysis

FDA is evaluating the need for regulatory action.

  • Lithium carbonate capsule
  • Lithium carbonate tablet
  • Lithium citrate syrup
  • Lithobid (lithium carbonate) tablet
  • Generic products containing lithium carbonate and lithium citrate

Acute generalized exanthematous pustulosis, Drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome and toxic epidermal necrolysis

FDA is evaluating the need for regulatory action.

  • Lovenox (enoxaparin sodium) injection
  • Generic products containing enoxaparin sodium

Device malfunction

FDA is evaluating the need for regulatory action.

  • Risperdal Consta (risperidone) injection
  • Risperdal M-tab (risperidone) tablet
  • Generic products containing risperidone

Acute generalized exanthematous pustulosis, Drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome and toxic epidermal necrolysis

FDA is evaluating the need for regulatory action.

  • Rituxan (rituximab) solution
  • Rituxan Hycela (hyaluronidase human and rituximab) injection

Pyoderma gangrenosum

FDA is evaluating the need for regulatory action.

  • Sensipar (cinacalcet hydrochloride) capsule
  • Parsabiv (etelcalcetide) injection
  • Prolia (denosumab) injection
  • Xvega (denosumab) injection

Drug interaction between calcimimetics (i.e. cinacalcet hydrochloride or etelcalcetide) and denosumab

FDA is evaluating the need for regulatory action.

  • Seroquel (quetiapine fumarate) tablet
  • Seroquel XR (quetiapine fumarate) tablet
  • Generic products containing quetiapine

Acute generalized exanthematous pustulosis, Drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome and toxic epidermal necrolysis

FDA is evaluating the need for regulatory action.

Stivarga (regorafenib) tablet

Cardiac failure

FDA is evaluating the need for regulatory action.

  • Sutent (sunitinib) capsule
  • Inlyta (axitinib) tablet
  • Nexavar (sorafenib tosylate) tablet
  • Votrient (pazopanib) tablet

Aortic dissection

FDA is evaluating the need for regulatory action.

Tagrisso (osimertinib) tablet

Severe cutaneous adverse events (SCAR):  Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, and bullous pemphigoid

FDA decided that no action is necessary at this time.

  • Zyprexa (olanzapine) tablet
  • Zyprexa Zydis (olanzapine) tablet
  • Zyprexa (olanzapine) injection
  • Zyprexa Relprevv (olanzapine) injection
  • Generic products containing olanzapine

Acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis

FDA is evaluating the need for regulatory action.

  • Zytiga (abiraterone acetate)
  • Yonsa (abiraterone acetate)
  • Generic products containing abiraterone

QT prolongation

FDA is evaluating the need for regulatory action.