2026年4月—6月 | FDA不良事件监测系统（AEMS）识别的新安全信息或严重风险潜在信号
April - June 2026 | New Safety Information or Potential Signals of Serious Risks Identified by the FDA Adverse Event Monitoring System (AEMS)
FDA 针对其不良事件监测系统（AEMS）2026年4月至6月识别的新安全信息或严重风险潜在信号，正评估多项药品是否需要监管行动。涉及 ABECMA、ALTUVIIIO、抗 CD20 单抗、BRAF 激酶抑制剂等；氯化钠注射液 USP 0.9%（某特定仿制药产品）因产品包装问题列为自愿召回。
ABECMA (idecabtagene vicleucel)Immune effector cell-associated enterocolitisFDA 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
PneumonitisFDA 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 sicknessFDA is evaluating the need for regulatory action.Attruby (acoramidis) tabletsRenal impairmentFDA 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
MyocarditisFDA is evaluating the need for regulatory action.BREYANZI (lisocabtagene maraleucel)Immune effector cell-associated enterocolitisFDA 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
ArthralgiaFDA 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
ColitisFDA 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 behaviorFDA 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 topicsFDA is evaluating the need for regulatory action.
Imidazoline containing products (nonprescription)
Cardiovascular, cerebrovascular, and imidazoline-related toxidrome events associated with intentional product misuseFDA is evaluating the need for regulatory action.
Imidazoline containing products (nonprescription)
Cardiovascular, cerebrovascular, and imidazoline-related toxidrome events associated with incorrect route of product administrationFDA is evaluating the need for regulatory action.LENMELDY (atidarsagene autotemcel)Cerebral hemorrhage following severe immune thrombocytopeniaFDA is evaluating the need for regulatory action.
Linezolid injection
Zyvox (linezolid) injection; tablets; oral suspension
PancreatitisFDA 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) capsulesSeizuresFDA is evaluating the need for regulatory action.
MEK inhibitors
- Cotellic (cobimetinib) tablets
- Mekinist (trametinib) tablets; oral solution
- Mektovi (binimetinib) tablets
MyocarditisFDA is evaluating the need for regulatory action.Nardil (phenelzine sulfate tablets)Drug-induced liver injuryFDA is evaluating the need for regulatory action.
Orexin receptor antagonists
- Belsomra (suvorexant) tablets
- Dayvigo (lemborexant) tablets
- Quviviq (daridorexant) tablets
Anaphylactic reactionFDA is evaluating the need for regulatory action.Rezdiffra (resmetirom) tabletsHypothyroidismFDA is evaluating the need for regulatory action.Sodium chloride injection, USP 0.9% (a particular generic product)Product packaging issueVoluntary recallVykat XR (diazoxide choline) extended-release tabletsFluid retentionFDA is evaluating the need for regulatory action.Winrevair (sotatercept-csrk) for injectionAnaphylactic reactionFDA is evaluating the need for regulatory action.
来源：FDA What's New Related to Drugs · fda.gov