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  6. Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS): July - September 2018
  1. Surveillance: Post Drug-Approval Activities

Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS): July - September 2018

Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS): July - September 2018

Product Name: Trade (Active Ingredient) or Product Class

Potential Signal of a Serious Risk / New Safety Information

Additional Information
(as of January 14, 2019)

  • Abilify (aripiprazole)
  • Clozaril (clozapine)
  • Fanapt (iloperidone)
  • Geodon (ziprasidone hydrochloride)
  • Invega (paliperidone)
  • Latuda (lurasidone hydrochloride)
  • Nuplazid (pimavanserin)
  • Rexulti (brexpiprazole)
  • Risperdal (risperidone)
  • Saphris (asenapine) sublingual
  • Seroquel (quetiapine fumarate)
  • Vraylar (cariprazine)
  • Zyprexa (olanzapine)
  • Generic products containing atypical antipsychotics

Atypical antipsychotics and serotonin syndrome

FDA is evaluating the need for regulatory action.

 

Amphetamines and amphetamine congeners for management of obesity

  • Desoxyn (methamphetamine hydrochloride) tablets
  • Didrex (benzphetamine hydrochloride) tablets
  • Phendimetrazine Tartrate extended-release capsules
  • Qsymia (phentermine and topiramate) extended-release capsules
  • Tenuate (diethylpropion hydrochloride) immediate-release tablets
  • Tenuate Dospan (diethylpropion hydrochloride) controlled-release tablets
  • Generic products containing amphetamine and amphetamine congeners for management of obesity

Death and sudden death

FDA is evaluating the need for regulatory action.

Injectible insulins and insulin analogs

Cutaneous amyloidosis

FDA is evaluating the need for regulatory action.

  • Brilinta (ticagrelor) tablets
  • Generic product containing ticagrelor

Central sleep apnea associated with the use of ticagrelor

FDA is evaluating the need for regulatory action.

  • Brilinta (ticagrelor) tablets
  • Crestor (rosuvastatin calcium) tablets
  • Lipitor (atorvastatin calcium) tablet
  • Liptruzet (ezetimibe and atorvastatin) tablets
  • Caduet (amlodipine, atorvastatin calcium)
  • Generic products containing rosuvastatin or atorvastatin
  • Generic products containing ticagrelor

Rhabdomyolysis due to Drug-Drug Interaction between
ticagrelor and certain HMG-CoA reductase inhibitors
(atorvastatin and rosuvastatin)

FDA is evaluating the need for regulatory action.

  • Campath (alemtuzumab) injection
  • Lemtrada (alemtuzumab) injection

Hemophagocytic Lymphohistiocytosis (HLH)

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

  • Campath (alemtuzumab) injection
  • Lemtrada (alemtuzumab) injection

Stroke, intracranial hemorrhage, and/or cervicocephalic arterial dissection

The “Boxed Warning” section of labeling was updated to include the risk of stroke.  The “Warnings and Precautions” section of labeling was updated to include the risk of stroke and cervicocephalic arterial dissection.
Campath labeling
Lemtrada labeling

Daptomycin injection

Infusion - related reactions

Eight drug product lots released to the market and within expiry were recalled voluntarily, with FDA’s agreement, up to the Hospital/Retail level, effective 6/29/2018, as published on FDA’s website.
Daptomycin injection drug safety recall

  • Eliquis (apixaban) tablets
  • Pradaxa (dabigatran etexilate mesylate) capsules
  • Savaysa (edoxaban) tablets
  • Xarelto (Rivaroxaban)

Acute kidney injury

FDA is evaluating the need for regulatory action.

  • Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) tablets
  • Odefsey (rilpivirine, emtricitabine, and tenofovir alafenamide) tablets
  • Descovy (emtricitabine and tenofovir alafenamide) tablets
  • Vemlidy (tenofovir and alafenamide) tablets
  • Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide) tablets

Hypersensitivity

FDA is evaluating the need for regulatory action.

Intravenous iron replacement products

  • Feraheme (ferumoxytol) injection
  • Ferrlecit (sodium ferric gluconate complex in sucrose) injection
  • INFeD (iron dextran) injection
  • Injectafer (ferric carboxymaltose) injection
  • Venofer (iron sucrose) injection

Fatal and severe hypersensitivity reactions

FDA is evaluating the need for regulatory action.

Pegfilgrastim injection products

Alveolar hemorrhage, hemoptysis

FDA is evaluating the need for regulatory action.

 

Ocrevus (ocrelizumab) injection

Anaphylaxis

FDA is evaluating the need for regulatory action.

PCSK9 Inhibitors

  • Praluent (alirocumab) injection
  • Repatha (evolocumab) injection

Influenza-like illness

The “Postmarketing Experience” section of labeling was updated to include flu-like illness.
Praluent labeling

Phenol

Serious adverse events associated with teething

FDA is evaluating the need for regulatory action.

Proton Pump Inhibitors

  • AcipHex (rabeprazole sodium) delayed-release tablets
  • AcipHex Sprinkle (rabeprazole sodium) delayed-release capsules
  • Dexilant (dexlansoprazole) delayed release capsules
  • Esomeprazole Strontium delayed-release capsules
  • Nexium (esomeprazole magnesium) delayed-release capsules; delayed- release oral suspension
  • Nexium IV (esomeprazole sodium) for injection
  • Pantoprazole Sodium for injection
  • Prevacid (lansoprazole) delayed-release capsules
  • Prevacid SoluTab (lansoprazole) delayed-release orally disintegrating tablets
  • Prilosec (omeprazole) delayed-release capsules
  • Protonix (pantoprazole sodium) delayed-release tablets; delayed-release oral suspension
  • Protonix IV (pantoprazole sodium) for injection
  • Zegerid (omeprazole and sodium bicarbonate) powder for oral suspension and capsules
  • Generic products containing  proton-pump inhibitors

Rebound acid hypersecretion

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

Rituxan Hycela (rituximab and hyaluronidase human) injection, and rituximab for injection products

Incorrect route of administration

FDA is evaluating the need for regulatory action.

Xifaxan (rifaximin) tablets

Rhabdomyolysis

FDA is evaluating the need for regulatory action.