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  6. Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS): January - March 2019
  1. Questions and Answers on FDA's Adverse Event Reporting System (FAERS)

Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS): January - March 2019

Product Name: Trade (Active Ingredient) or Product Class

Potential Signal of a Serious Risk / New Safety Information

Additional Information
(as of July 17, 2019)

  • Afinitor (everolimus)
  • Afinitor Disperz (everolimus)
  • Nexavar (sorafenib toxylate)

 

Thrombotic microangiopathy

FDA is evaluating the need for regulatory action.

  • Aimovig (erenumab-aooe) injection
  • Aljovy (fremanezumab-vfrm) injection
  • Emgality (galcanezumab-gnlm) injection

 

Constipation

FDA is evaluating the need for regulatory action.

  • Amoxil (amoxicillin)
  • Augmentin (amoxicillin and clavulanate potassium)
  • Moxatag (amoxicillin)
  • Omeclamox-Oak (omeprazole, amoxicillin, and clarithromycin)
  • Prevpac (amoxicillin, clarithromycin, and lansoprazole)
  • Generic products containing amoxicillin; amoxicillin and clavulanate potassium; omeprazole, amoxicillin, and clarithromycin; and amoxicillin, clarithromycin, and lansoprazole

 

Aseptic meningitis

FDA is evaluating the need for regulatory action.

  • Bavencio (avelumab)
  • Imfinzi (durvalumab)
  • Opdivo (nivolumab)
  • Tecentriq (atezolizumab)

Solid organ transplant rejection

FDA is evaluating the need for regulatory action.

Rubidium Rb 82 generators

  • CardioGen 82
  • Ruby-Fill

Excess radiation exposure to the patient due to elution of the generator with an incorrect solution containing calcium

The “Boxed Warning”, “Dosing and Administration,” “Contraindications,” and “Warnings and Precautions,” sections on labeling were updated to include information about using the correct solution to elute the generator and carefully following daily safety procedures for the system. 

Rubidium Rb 82 generator Drug Safety Communication (4/29/19)

  • Daklinza (daclatasvir dihydrochloride) tablet
  • Epclusa (sofosbuvir and velpatisvir) tablet
  • Harvoni (ledipasvir and sofosbuvir) tablet
  • Mavyret (glecaprevir and pibrentasvir) tablet
  • Sovaldi (sofosbuvir) tablets
  • Technivie (ombitsavir, paritaprevir, and ritonavir)
  • Viekira Pak (dasabuvir, ombitasvir, paritaprevir, and ritonavir) tablet
  • Viekira XR (dasabuvir, ombitasvir, paritaprevir, and ritonavir) tablet
  • Vosevi (sofosbuvir, velpatasvir, and voxilaprevir) tablet
  • Zepatier (elbasvir and grazoprevir) tablet

Dysglycemia

FDA is evaluating the need for regulatory action.

Esbriet (pirfenidone)

Drug Induced Liver Injury

FDA is evaluating the need for regulatory action.

Forteo (teriparatide)

Cutaneous calcification, including calciphylaxis

FDA is evaluating the need for regulatory action.

  • Fulphila (pegfilgrastim-jbdb)
  • Neulasta (pegfilgrastim)

 

Wrong dose errors in pediatric patients

FDA is evaluating the need for regulatory action.

  • Gilenya (fingolimod) capsule
  • Generic products containing fingolimod

Serious hepatotoxicity

FDA is evaluating the need for regulatory action.

  • Lamictal (lamotrigine)
  • Generic products containing lamotrigine

Brugada Syndrome

FDA is evaluating the need for regulatory action.

  • Mavyret (glecaprevir and pibrentasvir) tablet
  • Vosevi (Sofosbuvir, Velpatasvir, and Voxilaprevir) tablet
  • Zepatier (Elbasvir and Grazoprevir) tablet

Hepatic decompensation and hepatic failure

FDA is evaluating the need for regulatory action.

Non-steroidal anti-inflammatory drugs (NSAIDs)

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)

FDA is evaluating the need for regulatory action.

Pomalyst (pomalidomide)

Thyroid disorders

FDA is evaluating the need for regulatory action.

  • Signifor (pasireotide)
  • Signifor LAR (pasireotide)

Ketoacidosis

FDA is evaluating the need for regulatory action.

  • Sustiva (efavirenz)
  • Symfi Lo (efavirenz, lamivudine, tenofovir disoproxil fumarate)
  • Symfi (efavirenz, lamivudine, tenofovir disoproxil fumarate)
  • Atripla (efavirenz, emtricitabine, tenofovir disoproxil fumarate)
  • Generic products containing efavirenz

Ataxia and encephalopathy

FDA is evaluating the need for regulatory action.

  • Tygacil (tigecycline)
  • Generic products containing tigecycline

Hypofibrinogenemia

FDA is evaluating the need for regulatory action.

  • Vidaza (azacitidine)
  • Generic products containing azacitidine

Differentiation syndrome

FDA is evaluating the need for regulatory action.

Zydelig (idelalisib)

Heart failure

FDA decided that no action is necessary at this time based on available information.