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  4. Surveillance: Post Drug-Approval Activities
  5. FDA's Adverse Event Reporting System (FAERS)
  6. April - June 2022 | 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)

April - June 2022 | 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 February 21, 2023)

Afinitor (everolimus)

Afinitor Disperz (everolimus)

Rapamune (sirolimus)

Zortress (everolimus)

 

Drug interaction

FDA is evaluating the need for regulatory action.

Bavencio (avelumab)

Imfinzi (durvalumab)

Jemperli (dostarlimab-gxly)

Keytruda (pembrolizumab)

Libtayo (cemiplimab-rwlc)

Opdivo (nivolumab)

Tecentriq (atezolizumab)

 

Keratoacanthoma

FDA is evaluating the need for regulatory action.

Cabometyx (cabozantinib)

Cometriq (cabozantinib)

Generic products containing cabozantinib

 

Bradyarrhythmia (including conduction defects and disorders of sinus node function)

FDA is evaluating the need for regulatory action.

Calquence (acalabrutinib)

Pneumonitis

FDA is evaluating the need for regulatory action.

Calquence (acalabrutinib)

Tumour lysis syndrome

FDA is evaluating the need for regulatory action.

Elzonris (tagraxofusp-erzs)

Tumour lysis syndrome

FDA is evaluating the need for regulatory action.

Certain everolimus product (generic product for the trade name Afinitor)

Product packaging confusion

FDA is evaluating the need for regulatory action.

Glucagon-like peptide 1 (GLP-1) receptor agonists

 

  • Adlyxin (lixisenatide)

 

  • Byetta (exenatide)

 

  • Bydureon (exenatide)

 

  • Bydureon BCise (exenatide)

 

  • Mounjaro (tirzepatide)
  • Ozempic (semaglutide)
  • Rybelsus (semaglutide)
  • Saxenda (liraglutide recombinant)
  • Soliqua 100/33 (insulin glargine and lixisenatide)
  • Trulicity (dulaglutide)
  • Wegovy (semaglutide)
  • Xultophy 100/3.6 (insulin degludec and liraglutide) injection
  • Victoza (liraglutide recombinant)

Generic products containing glucagon-like peptide 1 (GLP-1) receptor agonists

 

Intestinal obstruction

FDA is evaluating the need for regulatory action.

Proglycem (diazoxide)

Generic products containing diazoxide

Pericardial effusion

FDA is evaluating the need for regulatory action.

Reblozyl (luspatercept-aamt)

Sickle cell anemia with crisis

FDA is evaluating the need for regulatory action.

Saxenda (liraglutide recombinant)

Victoza (liraglutide recombinant)

Xultophy 100/3.6 (insulin degludec and liraglutide) injection

Generic products containing liraglutide

Cutaneous amyloidosis

The “Postmarketing Experience” section of the labeling was updated to include the risk of cutaneous amyloidosis.

Saxenda labeling

Scenesse (afamelanotide)

Hypersensitivity

FDA is evaluating the need for regulatory action.

Talzenna (talazoparib)

Thrombotic microangiopathy

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

Tazverik (tazemetostat)

Blood bromide increased

FDA is evaluating the need for regulatory action.

Tezspire (tezepelumab-ekko)

Anaphylactic reaction

FDA is evaluating the need for regulatory action.

Tyvaso (treprostinil)

Tyvaso DPI (treprostinil)

 

Bronchospasm

The “Warnings and Precautions” section of the labeling was updated May 2022 to include bronchospasm.

Tyvaso labeling

 

Zolgensma (onasemnogene abeparvovec-xioi)

 

Hepatotoxicity-associated fatality

The “Boxed Warning”, “Warnings and Precautions”, “Postmarketing Experience” and “Patient Counseling Information” sections of the labeling were updated in February 2023 to include fatal cases of acute liver failure.

 

Zolgensma labeling

 

 

 

 

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