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  5. FDA's Adverse Event Reporting System (FAERS)
  6. July - September 2021 | 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 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 December 20, 2021)

Ajovy (fremanezumab-vfrm)

Emgality (galcanezumab)

Nurtec ODT (rimegepant)

Ubrelvy (ubrogepant)

Vyepti (eptinezumab-jjmr)

 

Hypertension

FDA decided regulatory action is not needed at this time.

Apriso (mesalamine)

Asacol (mesalamine)

Asacol HD (mesalamine)

Azulfidine (sulfasalazine)

Azulfidine EN-Tabs (sulfasalazine)

Canasa (mesalamine)

Colazal (balsalazide disodium)

Delzicol (mesalamine)

Dipentum (osalazine sodium)

Giazo (balsalazide disodium)

Lialda (mesalamine)

Rowasa (mesalamine)

Pentasa (mesalamine)

 

Severe cutaneous adverse reactions

The Warnings and Precautions section of the labeling was updated November 2021 to include severe cutaneous adverse reactions.

 

Example:  Delzicol labeling

Avastin (bevacizumab)

Mvasi (bevacizumab-awwb)

Zirabev (bevacizumab-bvzr)

 

Pancreatitis

FDA is evaluating the need for regulatory action.

Avastin (bevacizumab)

Mvasi (bevacizumab-awwb)

Zirabev (bevacizumab-bvzr)

 

Anaphylactic shock

FDA is evaluating the need for regulatory action.

Ayvakit (avapritinib)

 

Photosensitivity reaction

FDA is evaluating the need for regulatory action.

Azacitidine

Onureg (azacitidine)

Vidaza (azacitidine)

Pericarditis

FDA is evaluating the need for regulatory action.

Bavencio (avelumab)

Imfinzi (durvalumab)

Libtayo (cemiplimab-rwlc)

Keytruda (pembrolizumab

Opdivo (nivolumab)

Tecentriq (atezolizumab)

Yervoy (ipilimumab)

Tumour lysis syndrome

FDA is evaluating the need for regulatory action.

Cymbalta (duloxetine hydrochloride)

Drizalma Sprinkle (duloxetine hydrochloride)

Generic products containing duloxetine hydrochloride

Anosmia, Hyposmia

FDA is evaluating the need for regulatory action.

Darzalex (daratumumab)

Darzalex Faspro (daratumumab and hyaluronidase-fihj)

Blood stem cell transplant failure

FDA is evaluating the need for regulatory action.

Dipeptidyl peptidase-4 (DPP-4) inhibitors

  • Glyxambi (empagliflozin and linagliptin)
  • Janumet (metformin hydrochloride and sitagliptin phosphate)
  • Janumet XR (metformin hydrochloride and sitagliptin phosphate)
  • Jentadueto (linagliptin and metformin hydrochloride)
  • Jentadueto XR (linagliptin and metformin hydrochloride)
  • Kazano (alogliptin and metformin hydrochloride)
  • Kombiglyze XR (metformin hydrochloride and saxagliptin)
  • Nesina (alogliptin)
  • Onglyza (saxagliptin)
  • Oseni (alogliptin and pioglitazone)
  • Steglujan (ertugliflozin and sitagliptin)
  • Tradjenta (linagliptin)
  • Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride)
  • Qtern (saxagliptin and dapagliflozin)

Generic products containing dipeptidyl peptidase-4 inhibitors

 

Tubulointerstitial nephritis

FDA is evaluating the need for regulatory action.

Dupixent (dupilumab)

Angioedema

FDA is evaluating the need for regulatory action.

Glucagon-like peptide-1 (GLP-1) analogues

  • Adlyxin (lixisenatide)
  • Bydureon (exenatide)
  • Bydureon BCise (exenatide)
  • Byetta (exenatide)
  • Ozempic (semaglutide)
  • Rybelsus (semaglutide)
  • Saxenda (liraglutide)
  • Soliqua 100/33 (insulin glargine and lixisenatide injection)
  • Trulicity (dulaglutide)
  • Victoza (liraglutide)
  • Wegovy (semaglutide)
  • Xultophy 100/3.6 (insulin degludec and liraglutide injection)

Generic products containing glucagon-like peptide-1 analogues

Gallbladder related disorders

FDA is evaluating the need for regulatory action.

Gonadotropin releasing hormone (GnRH) analogues

  • Fensolvi (leuprolide acetate)
  • Lupron Depot-PED (leuprolide acetate)
  • Supprelin LA (histrelin acetate)
  • Synarel (nafarelin acetate)
  • Triptodur (triptorelin)

Idiopathic intracranial hypertension

FDA is evaluating the need for regulatory action.

Jakafi (ruxolitinib phosphate)

 

Herpes simplex virus (HSV) reactivation and/or disseminated HSV

 

FDA is evaluating the need for regulatory action.

Ibrance (palbociclib)

Kisqali (ribociclib)

Kisqali Femara Co-Pack (letrozole and ribociclib)

 

Embolic and thrombotic events, venous

 

FDA is evaluating the need for regulatory action.

Ocrevus (ocrelizumab)

Myocardial infarction

FDA is evaluating the need for regulatory action.

Potassium Chloride

Product preparation error

FDA is evaluating the need for regulatory action.

Praxbind (idarucizumab)

Medication error

FDA is evaluating the need for regulatory action.

Qbrexza (glycopyrronium tosylate)

Accidental exposure to product

FDA is evaluating the need for regulatory action.

Qbrexza (glycopyrronium tosylate)

Urinary retention

FDA is evaluating the need for regulatory action.

Sodium-glucose cotransporter-2 (SGLT-2) inhibitors

  • Farxiga (dapagliflozin)
  • Glyxambi (empagliflozin and linagliptin)
  • Invokamet (canagliflozin and metformin hydrochloride)
  • Invokamet XR (canagliflozin and metformin hydrochloride)
  • Invokana (canagliflozin)
  • Jardiance (empagliflozin)
  • Qtern (saxagliptin and dapagliflozin)
  • Steglatro (ertugliflozin)
  • Steglujan (ertugliflozin and sitagliptin)
  • Segluromet (ertugliflozin and metformin hydrochloride)
  • Synjardy (empagliflozin and metformin hydrochloride)
  • Synjardy XR (empagliflozin and metformin hydrochloride)
  • Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride)
  • Xigduo XR (dapagliflozin and metformin)

Generic products containing sodium-glucose cotransporter-2 (SGLT-2) inhibitors

Tubulointerstitial nephritis

FDA is evaluating the need for regulatory action.

Somatostatin Receptor Imaging Agents

  • Detectnet
  • Gallium Dotatoc (GA 68)
  • Octreoscan (Indium In 111 Pentreotide)
  • Netspot (Gallium GA 68 Dotatate)

 

Hypersensitivity

FDA is evaluating the need for regulatory action.

 

Stromectol (ivermectin)

Generic products containing ivermectin

Off label use

FDA is evaluating the need for regulatory action.

Consumer Update September 2021

 

Stromectol (ivermectin)

Generic products containing ivermectin

Neurotoxicity

FDA is evaluating the need for regulatory action.

 

Sunosi (solriamfetol hydrochloride)

 

Hypersensitivity

FDA is evaluating the need for regulatory action.

Vivitrol (naltrexone)

Incorrect route of product administration

FDA is evaluating the need for regulatory action.

Xcopri (cenobamate)

Psychiatric disorders

FDA is evaluating the need for regulatory action.
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