April - June 2026 | New Safety Information or Potential Signals of Serious Risks Identified by the FDA Adverse Event Monitoring System (AEMS)

_{The drug product(s) included in any of the new safety information or potential signals of serious risks listed below may also include generic drug product(s) and biosimilar or interchangeable biosimilar biological product(s), as appropriate.}

Product Name: Trade (Active Ingredient) or Product Class	New Safety Information or Potential Signal of a Serious Risk	Additional Information (as of September 4, 2026)
ABECMA (idecabtagene vicleucel)	Immune effector cell-associated enterocolitis	FDA is evaluating the need for regulatory action.
ALTUVIIIO [antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl]	Thromboembolic events in patients with cardiovascular or venous thrombotic risk factors	FDA is evaluating the need for regulatory action.
Anti-CD20 monoclonal antibodies Briumvi (ublituximab-xiiy) injection Kesimpta (ofatumumab) injection Ocrevus (ocrelizumab) injection Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) injection	Pneumonitis	FDA is evaluating the need for regulatory action.
Anti-CD20 monoclonal antibodies Briumvi (ublituximab-xiiy) injection Kesimpta (ofatumumab) injection Ocrevus (ocrelizumab) injection Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) injection	Serum sickness	FDA is evaluating the need for regulatory action.
Attruby (acoramidis) tablets	Renal impairment	FDA is evaluating the need for regulatory action.
BRAF kinase inhibitors Braftovi (encorafenib) capsules Ojemda (tovorafenib) for oral suspension; tablets Tafinlar (dabrafenib) capsules; tablets Zelboraf (vemurafenib) tablets	Myocarditis	FDA is evaluating the need for regulatory action.
BREYANZI (lisocabtagene maraleucel)	Immune effector cell-associated enterocolitis	FDA is evaluating the need for regulatory action.
Calcitonin gene-related peptide (CGRP) inhibitors Aimovig (erenumab-aooe) injection Ajovy (fremanezumab-vfrm) injection Emgality (galcanezumab-gnlm) injection Nurtec ODT (rimegepant) orally disintegrating tablets Qulipta (atogepant) tablets Ubrelvy (ubrogepant) tablets Vyepti (eptinezumab-jjmr) injection Zavzpret (zavegepant) nasal spray	Arthralgia	FDA is evaluating the need for regulatory action.
Cyclin dependent kinase (CDK) 4 and 6 inhibitors Ibrance (palbociclib) capsules; tablets Kisqali (ribociclib) tablets Kisqali Femara Co-pack (ribociclib tablets; letrozole tablets) co-packaged for oral use Verzenio (abemaciclib) tablets	Colitis	FDA is evaluating the need for regulatory action.
Cystic fibrosis transmembrane conductance regulator (CFTR) targeted drugs Alyftrek (vanzacaftor, tezacaftor, and deutivacaftor) tablets Kalydeco (ivacaftor) tablets; oral granules Orkambi (lumacaftor and ivacaftor) tablets; oral granules Symdeko (tezacaftor/ivacaftor) tablets Trikafta (elexacaftor, tezacaftor, and ivacaftor tablets; ivacaftor tablets) co-packaged Trikafta (elexacaftor, tezacaftor, and ivacaftor granules; ivacaftor oral granules) co-packaged	Abnormal behavior	FDA is evaluating the need for regulatory action.
Cystic fibrosis transmembrane conductance regulator (CFTR) targeted drugs  Alyftrek (vanzacaftor, tezacaftor, and deutivacaftor) tablets Kalydeco (ivacaftor) tablets; oral granules Orkambi (lumacaftor and ivacaftor) tablets; oral granules Symdeko (tezacaftor/ivacaftor) tablets Trikafta (elexacaftor, tezacaftor, and ivacaftor tablets; ivacaftor tablets) co-packaged Trikafta (elexacaftor, tezacaftor, and ivacaftor granules; ivacaftor oral granules) co-packaged	Pregnancy and neonatal topics	FDA is evaluating the need for regulatory action.
Imidazoline containing products (nonprescription)	Cardiovascular, cerebrovascular, and imidazoline-related toxidrome events associated with intentional product misuse	FDA is evaluating the need for regulatory action.
Imidazoline containing products (nonprescription)	Cardiovascular, cerebrovascular, and imidazoline-related toxidrome events associated with incorrect route of product administration	FDA is evaluating the need for regulatory action.
LENMELDY (atidarsagene autotemcel)	Cerebral hemorrhage following severe immune thrombocytopenia	FDA is evaluating the need for regulatory action.
Linezolid injection Zyvox (linezolid) injection; tablets; oral suspension	Pancreatitis	FDA is evaluating the need for regulatory action.
Lutathera (lutetium Lu 177 dotatate) injection Pluvicto (lutetium Lu 177 vipivotide tetraxetan) injection	Wrong drug administered	FDA is evaluating the need for regulatory action.
Lynkuet (elinzanetant) capsules	Seizures	FDA is evaluating the need for regulatory action.
MEK inhibitors Cotellic (cobimetinib) tablets Mekinist (trametinib) tablets; oral solution Mektovi (binimetinib) tablets	Myocarditis	FDA is evaluating the need for regulatory action.
Nardil (phenelzine sulfate tablets)	Drug-induced liver injury	FDA is evaluating the need for regulatory action.
Orexin receptor antagonists Belsomra (suvorexant) tablets Dayvigo (lemborexant) tablets Quviviq (daridorexant) tablets	Anaphylactic reaction	FDA is evaluating the need for regulatory action.
Rezdiffra (resmetirom) tablets	Hypothyroidism	FDA is evaluating the need for regulatory action.
Sodium chloride injection, USP 0.9% (a particular generic product)	Product packaging issue	Voluntary recall
Vykat XR (diazoxide choline) extended-release tablets	Fluid retention	FDA is evaluating the need for regulatory action.
Winrevair (sotatercept-csrk) for injection	Anaphylactic reaction	FDA is evaluating the need for regulatory action.