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
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. |
|
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.
|
|
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.
|