Adcetris (brentuximab vedotin)
Guillain-Barre syndrome
FDA determined that no action is necessary at the time based on available information.
Arzerra (ofatumumab)
Gazyva (obinutuzumab)
Riabni (rituximab-arrx)
Rituxan (rituximab)
Rituxan Hycela (rituximab and hyaluronidase human)
Ruxience (rituximab-pvvr)
Truxima (rituximab-abbs)
Colitis
FDA determined that no action is necessary at the time based on available information.
Balversa (erdafitinib)
Calciphylaxis
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.
Balversa labeling
Bavencio (avelumab)
Keytruda (pembrolizumab)
Opdivo (nivolumab)
Yervoy (ipilimumab)
Imfinzi (durvalumab) *
Necrotizing fasciitis
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)*
Hypoglycemia in pediatric patients
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.
Bosulif (bosutinib monohydrate)
Gleevec (imatinib mesylate)
Iclusig (ponatinib)
Sprycel (dasatinib)
Tasigna (nilotinib)
Osteonecrosis
The "Adverse Reactions" section of the Tasigna labeling was updated in February 2024 to include information about osteonecrosis.
Tasigna labeling
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.
Cablivi (caplacizumab-yhdp)
Hemorrhage
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.
Cablivi labeling
Cyramza (ramucirumab)
Cardiac failure
The "Adverse Reactions" section of the labeling was updated in March 2022 to include information about heart failure.
Cyramza labeling
Doxil (doxorubicin hydrochloride)
Acute interstitial pneumonitis
FDA determined that no action is necessary at the time based on available information.
Gleevec (imatinib mesylate)
Tasigna (nilotinib)
Myasthenia gravis
FDA determined that no action is necessary at the time based on available information.
Ibrance (palbociclib)
Kisqali (ribociclib)
Kisqali Femara Co-Pack (ribociclib; letrozole)
Verzenio (abemaciclib)
Radiation recall phenomenon
FDA determined that no action is necessary at the time based on available information.
Lokelma (sodium zirconium cyclosilicate)
Gastrointestinal disorders
FDA determined that no action is necessary at the time based on available information.
Padcev (enfortumab vedotin-ejfv)
Pancreatitis
FDA determined that no action is necessary at the time based on available information.
Padcev (enfortumab vedotin-ejfv)
Pneumonitis
The "Adverse Reactions", "Warnings and Precautions", and "Patient Counseling Information" sections of the labeling were updated in July 2021 to include information about pneumonitis.
Padcev labeling
Poteligeo (mogamulizumab-kpkc)
Cytomegalovirus viraemia
The "Adverse Reactions" section of the labeling was updated in March 2022 to include cytomegalovirus infection.
Poteligeo labeling
Procysbi (cysteamine bitartrate)
Generic products containing cysteamine bitartrate
Fibrosing colonopathy
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
Sarclisa (isatuximab-irfc)
Herpes zoster
The "Dosage and Administration", "Adverse Reactions", and "Patient Information" sections of the labeling were updated in July 2022 to include information about herpes zoster.
Sarclisa labeling
Sprycel (dasatinib)
Drug-induced liver injury
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.
Sprycel labeling
Taxotere (docetaxel)
Rhabdomyolysis
FDA determined that no action is necessary at the time based on available information.
Veklury (remdesivir)
Bradycardia
FDA determined that no action is necessary at the time based on available information.
Zepzelca (lurbinectedin)
Extravasation
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.
Zepzelca labeling
Zepzelca (lurbinectedin)
Tumor lysis syndrome
The “Adverse Reactions” section of the labeling was updated in April 2022 to include tumor lysis syndrome.
Zepzelca labeling
Zepzelca (lurbinectedin)
Rhabdomyolysis
The “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information”, and “Patient Information” sections of the labeling were updated in April 2022 to include rhabdomyolysis.
Zepzelca labeling
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