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  6. April - June 2021 | 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 2021 | 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 10, 2021)

Adcetris (brentuximab vedotin)

Guillain-Barre syndrome

FDA is evaluating the need for regulatory action.

Arzerra (ofatumumab)
Gazyva (obinutuzumab)
Riabni (rituximab-arrx)
Rituxan (rituximab)
Rituxan Hycela (rituximab hyaluronidase human)
Ruxience (rituximab-pvvr)
Truxima (rituximab-abbs)

Colitis

FDA is evaluating the need for regulatory action.

Balversa (erdafitinib)

Calciphylaxis

FDA is evaluating the need for regulatory action.

Bavencio (avelumab)
Keytruda (pembrolizumab)
Opdivo (nivolumab)
Yervoy (ipilimumab)

Necrotizing fasciitis

FDA is evaluating the need for regulatory action.

Beta-blockers

  • Betapace (sotalol hydrochloride)
  • Betapace AF (sotalol hydrochloride)
  • Brevibloc (esmolol hydrochloride)
  • Bystolic (nebivolol)
  • Byvalson (nebivolol and valsartan)
  • Coreg (carvedilol)
  • Coreg CR (carvedilol)
  • Corgard (nadolol)
  • Corzide (nadolol and bendroflumethiazide)
  • Dutoprol (metoprolol succinate and hydrochlorothiazide)
  • Kapspargo Sprinkle (metoprolol succinate)
  • Levatol (penbutolol sulfate)
  • Lopressor HCT  (metoprolol tartrate and hydrochlorothiazide)
  • Sectral (acebutolol hydrochloride)
  • Sotylize (sotalol hydrochloride)
  • Tenoretic (atenolol and chlorthalidone)
  • Toprol XL (metoprolol succinate)
  • Trandate (labetalol hydrochloride)
  • Zebeta (bisoprolol fumarate)
  • Ziac (bisoprolol fumarate and hydrochlorothiazide)

Generic products containing beta-blockers

Hypoglycaemia in pediatric patients

FDA is evaluating the need for regulatory action.

Bosulif (bosutinib monohydrate)
Gleevec (imatinib mesylate)
Iclusig (ponatinib)
Sprycel (dasatinib)
Tasigna (nilotinib)

Osteonecrosis

FDA is evaluating the need for regulatory action.

Cablivi (caplacizumab-yhdp)

Haemorrhage

FDA is evaluating the need for regulatory action.

Cyramza (ramucirumab)

Cardiac failure

FDA is evaluating the need for regulatory action.

Docetaxel
Taxotere (docetaxel)

Rhabdomyolysis

FDA is evaluating the need for regulatory action.

Doxil (doxorubicin hydrochloride)

Acute interstitial pneumonitis

FDA is evaluating the need for regulatory action.

Gleevec (imatinib mesylate)
Tasigna (nilotinib)

Myasthenia gravis

FDA is evaluating the need for regulatory action.

Ibrance (palbociclib)
Kisqali (ribociclib)
Kisqali Femara Co-Pack (ribociclib; letrozole)
Verzenio (abemaciclib)

Radiation recall phenomenon 

FDA is evaluating the need for regulatory action.

Lokelma (sodium zirconium cyclosilicate)

Gastrointestinal disorders

FDA is evaluating the need for regulatory action.

Padcev (enfortumab vedotin-ejfv)

Pancreatitis

FDA is evaluating the need for regulatory action.

Padcev (enfortumab vedotin-ejfv)

Pneumonitis

FDA is evaluating the need for regulatory action.

Poteligeo (mogamulizumab-kpkc)

Cytomegalovirus viraemia

FDA is evaluating the need for regulatory action.

Procysbi (cysteamine bitartrate)
Generic products containing cysteamine bitartrate

Fibrosing colonopathy

FDA is evaluating the need for regulatory action.

Sarclisa (isatuximab-irfc)

Herpes zoster

FDA is evaluating the need for regulatory action.

Sprycel (dasatinib)

Drug-induced liver injury

FDA is evaluating the need for regulatory action.

Veklury (remdesivir)

Bradycardia

FDA is evaluating the need for regulatory action.

Zepzelca (lurbinectedin)

Extravasation

FDA is evaluating the need for regulatory action.

Zepzelca (lurbinectedin)

Tumor lysis syndrome

FDA is evaluating the need for regulatory action.

Zepzelca (lurbinectedin)

Rhabdomyolysis

FDA is evaluating the need for regulatory action.

 
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