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  6. July - September 2018 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
  1. FDA's 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)

Product Name: Trade (Active Ingredient) or Product Class

Potential Signal of a Serious Risk / New Safety Information

Additional Information
(as of January 31, 2025)

  • 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

Updated

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

 

Amphetamines and amphetamine congeners for management of obesity

  • Desoxyn (methamphetamine hydrochloride) tablets
  • Didrex (benzphetamine hydrochloride) tablets
  • Fendique ER (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

Updated

FDA determined that no action is necessary at this time based on available information. FDA is continuing to monitor the issue.

  • Brilinta (ticagrelor) tablets
  • Generic product containing ticagrelor
Central sleep apnea associated with the use of ticagrelor

Updated

The “Adverse Reactions” section of the labeling was updated in September 2020 to include central sleep apnea, Cheyne-Stokes respiration.

Example: Brilinta labeling

  • 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)

Updated

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

  • 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 dissectionThe “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 injectionInfusion - related reactionsEight 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

Updated

FDA determined that no action is necessary at this time based on available information. FDA is continuing to monitor the issue.

  • 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

Updated

The “Adverse Reactions” section of the Genvoya, Odefsey, and Descovy labeling was updated between December 2018 and December 2019 to include angioedema, urticaria, and rash.

Genvoya labeling

Odefsey labeling

Descovy labeling

The “Adverse Reactions” section of the Vemlidy and Biktarvy labeling was updated between February 2019 and June 2019 to include angioedema and urticaria.

Vemlidy labeling

Biktarvy labeling

Injectable insulins and insulin analogsCutaneous amyloidosis

Updated

The “Dosage and Administration”, “Warnings and Precautions”, “Adverse Reactions”, and “Patient Information” sections of the injectable insulin and insulin analog labeling were updated between October 2019 and November 2019 to include cutaneous amyloidosis.

Example: Humulin N labeling

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

Updated

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

Pegfilgrastim injection productsAlveolar hemorrhage, hemoptysis

Updated

The “Adverse Reactions” section of the pegfilgrastim product labeling was updated between April 2019 and May 2019 to include alveolar hemorrhage.

Example: Neulasta labeling

Ocrevus (ocrelizumab) injectionAnaphylaxis

Updated

The “Warnings and Precautions” section of the Ocrevus labeling was updated in January 2020 to include anaphylaxis.

Ocrevus labeling

PCSK9 Inhibitors

  • Praluent (alirocumab) injection
  • Repatha (evolocumab) injection
Influenza-like illnessThe “Postmarketing Experience” section of labeling was updated to include flu-like illness.
Praluent labeling
PhenolSerious adverse events associated with phenol-containing teething products

Updated

FDA plans to issue an FDA-initiated proposed order that addresses the GRASE status of OTC oral health care drug products containing phenol preparations labeled for anesthetic/analgesic indications.

See Annual Forecast for Planned Monograph Activities | FDA.

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 hypersecretionFDA decided that no action is necessary at this time based on available information.
Rituxan Hycela (rituximab and hyaluronidase human) injection, and rituximab for injection productsIncorrect route of administration

Updated

The “Dosage and Administration” section of the labeling was revised in May 2020 to include information about incorrect route of administration.

Rituxan Hycela labeling

Xifaxan (rifaximin) tabletsRhabdomyolysis

Updated

The “Adverse Reactions” section of the labeling was updated in November 2020 to include information about rhabdomyolysis.

Xifaxan labeling

 

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