April - June 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
FDA determined that no action is necessary at the time based on available information.
Gazyva (obinutuzumab)
Riabni (rituximab-arrx)
Rituxan (rituximab)
Rituxan Hycela (rituximab and hyaluronidase human)
Ruxience (rituximab-pvvr)
Truxima (rituximab-abbs)
FDA determined that no action is necessary at the time based on available information.
The "Warnings and Precautions", "Patient Counseling Information", and the "Patient Information" sections of the labeling were updated in April 2022 to include information about soft tissue mineralization, including calciphylaxis.
Bavencio (avelumab)
Keytruda (pembrolizumab)
Opdivo (nivolumab)
Yervoy (ipilimumab)
Imfinzi (durvalumab) *
FDA determined that no action is necessary at this time based on available information.
*An administrative error resulted in the omission of Imfinzi (durvalumab) from the list of product names. Imfinzi was added after the initial quarterly report was posted.
Beta-blockers
- Betapace (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)
- Lopressor HCT (metoprolol tartrate and hydrochlorothiazide)
- Sectral (acebutolol hydrochloride)
- Sotylize (sotalol hydrochloride)
- Tenoretic (atenolol and chlorthalidone)
- Toprol XL (metoprolol succinate)
- Trandate (labetalol hydrochloride)
- Ziac (bisoprolol fumarate and hydrochlorothiazide)
Generic products containing beta-blockers
- Hemangeol (Propranolol Hydrochloride)*
- Inderal LA (Propranolol Hydrochloride)*
- Innopran XL (Propranolol hydrochloride)*
- Lopressor (metoprolol tartrate)*
- Tenormin (Atenolol)*
The "Warnings and Precautions" and "Patient Counseling Information" sections of the labeling were updated between March 2023 and June 2024 to add additional information regarding hypoglycemia.
Example: Coreg labeling
An administrative error resulted in the inclusion of Betapace AF, Levatol, and Zebeta in the list of product names at the time of the initial quarterly posting.
*An administrative error resulted in the omission of Hemangeol, Inderal LA, Innopran XL, Lopressor, and Tenormin from the list of product names and was added after the initial quarterly report was posted.
Gleevec (imatinib mesylate)
Iclusig (ponatinib)
Sprycel (dasatinib)
Tasigna (nilotinib)
The "Adverse Reactions" section of the Tasigna labeling was updated in February 2024 to include information about osteonecrosis.
FDA determined that Gleevec and Sprycel are adequately labeled for osteonecrosis, and that no further regulatory action is needed at this time.
FDA determined no action is necessary at this time for Iclusig and Bosulif based on available information.
The "Warnings and Precautions", "Drug Interactions", and "Patient Counseling Information" sections of the labeling were updated in February 2022 to include information about life-threatening and fatal bleeding.
The "Adverse Reactions" section of the labeling was updated in March 2022 to include information about heart failure.
FDA determined that no action is necessary at the time based on available information.
Tasigna (nilotinib)
FDA determined that no action is necessary at the time based on available information.
Kisqali (ribociclib)
Kisqali Femara Co-Pack (ribociclib; letrozole)
Verzenio (abemaciclib)
FDA determined that no action is necessary at the time based on available information.
FDA determined that no action is necessary at the time based on available information.
FDA determined that no action is necessary at the time based on available information.
The "Adverse Reactions", "Warnings and Precautions", and "Patient Counseling Information" sections of the labeling were updated in July 2021 to include information about pneumonitis.
The "Adverse Reactions" section of the labeling was updated in March 2022 to include cytomegalovirus infection.
Generic products containing cysteamine bitartrate
The "Warnings and Precautions", "Adverse Reactions", "Patient Information", and "Patient Counseling Information" sections of the labeling were updated in February 2022 to include information about fibrosing colonopathy.
Example: Procysbi labeling
The "Dosage and Administration", "Adverse Reactions", and "Patient Information" sections of the labeling were updated in July 2022 to include information about herpes zoster.
The “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information” and “Patient Information” sections of the labeling were updated in February 2023 to include information about hepatotoxicity.
FDA determined that no action is necessary at the time based on available information.
FDA determined that no action is necessary at the time based on available information.
The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in April 2022 to include information about extravasation.
The “Adverse Reactions” section of the labeling was updated in April 2022 to include tumor lysis syndrome.
The “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information”, and “Patient Information” sections of the labeling were updated in April 2022 to include rhabdomyolysis.
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