October - December 2024 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
The drug product(s) included in any of the potential signals of serious risks/new safety information listed below may also include the generic version of the drug product(s), if there are generic versions approved for use by the FDA at the time of this publication.
| Product Name: Trade (Active Ingredient) or Product Class | Potential Signal of a Serious Risk / New Safety Information | Additional Information (as of March 6, 2025) |
|---|---|---|
Alecensa (alectinib) capsules Alunbrig (brigatinib) tablets Lorbrena (lorlatinib) tablets Zykadia (ceritinib) capsules; tablets | Optic neuropathy | FDA is evaluating the need for regulatory action. |
Antidepressants
| Discontinuation-emergent cataplexy | FDA is evaluating the need for regulatory action. |
| Balversa (erdafitinib) tablets | Cataract | FDA is evaluating the need for regulatory action. |
| Balversa (erdafitinib) tablets | Epiphyseal disorders | FDA is evaluating the need for regulatory action. |
| Bivigam Immune Globulin Intravenous (Human) | Increased hypersensitivity reactions in patients receiving certain product lots | Voluntary Lot Withdrawals of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) for Increased Reports of Allergic/Hypersensitivity Reactions |
Blincyto (blinatumomab) for injection Columvi (glofitamab-gxbm) injection Elrexfio (elranatamab-bcmm) injection Epkinly (epcoritamab-bysp) injection Imdelltra (tarlatamab-dlle) for injection Kimmtrak (tebentafusp-tebn) injection Talvey (talquetamab-tgvs) injection Tecvayli (teclistamab-cqyv) injection | Hemophagocytic lymphohistiocytosis | FDA is evaluating the need for regulatory action. |
| Briviact (brivaracetam) injection; oral solution, tablets | Stevens-Johnson syndrome (SJS) | FDA is evaluating the need for regulatory action. |
Cabometyx (cabozantinib) tablets Cometriq (cabozantinib) capsules | Cardiac failure | FDA is evaluating the need for regulatory action. |
Celexa (citalopram) tablets Citalopram capsules Lexapro (escitalopram) oral solution; tablets | Cutaneous vasculitis | FDA is evaluating the need for regulatory action. |
Cellcept (mycophenolate mofetil) capsules; tablets Cellcept Intravenous (mycophenolate mofetil) for injection Cellcept Oral Suspension (mycophenolate mofetil) Myfortic (mycophenolic acid) delayed-release tablets Myhibbin (mycophenolate mofetil oral suspension) | Anaphylactic reaction | FDA is evaluating the need for regulatory action. |
Cetirizine and levocetirizine products
| Drug withdrawal syndrome, specifically rebound pruritus | FDA is evaluating the need for regulatory action. |
| Coly-Mycin M Parenteral (colistimethate for injection, USP) | Pseudo-Bartter syndrome | FDA is evaluating the need for regulatory action. |
| Cyklokapron (tranexamic acid) injection | Wrong route of administration error (inadvertent intrathecal administration instead of recommended intravenous administration) | FDA is evaluating the need for regulatory action. An FDA Alert was issued on December 3, 2020, and updated on February 10, 2025. |
| Dupixent (dupilumab) injection | Cutaneous T-cell lymphoma | FDA is evaluating the need for regulatory action. |
Gallium GA 68 Gozetotide* Injection Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) Locametz (kit for the preparation of gallium Ga 68 gozetotide injection) *Gozetotide is also known as PSMA-11 | Injection site pain | FDA is evaluating the need for regulatory action. |
Gleevec (imatinib mesylate) tablets Danziten (nilotinib) tablets Methotrexate injection Iclusig (ponatinib) tablets Imkeldi (imatinib) oral solution Phyrago (dasatinib) tablets Tasigna (nilotinib) capsules Sprycel (dasatinib) tablets | Drug interaction | FDA is evaluating the need for regulatory action. |
Glucagon-like peptide-1 (GLP-1) receptor agonists
| Non-arteritic anterior ischemic optic neuropathy (NAION) | FDA is evaluating the need for regulatory action. |
Gonadotropin releasing hormone (GnRH) agonists
| Suicidal and self-injurious behaviors | FDA is evaluating the need for regulatory action. |
Inrebic (fedratinib) capsules Ojjaara (momelotinib) tablets Vonjo (pacritinib) capsules | Drug withdrawal syndrome | FDA is evaluating the need for regulatory action. |
Jylamvo (methotrexate) oral solution Methotrexate tablets Xatmep (methotrexate) oral solution | Inappropriate schedule of product administration | FDA is evaluating the need for regulatory action. |
| Kerendia (finerenone) tablets | Hypersensitivity | FDA is evaluating the need for regulatory action. |
| Nexplanon (etonogestrel implant) | Site specific procedural complications | FDA is evaluating the need for regulatory action. |
| Palynziq (pegvaliase-pqpz) injection | Injection site infection | FDA is evaluating the need for regulatory action. |
Panzyga Immune Globulin Intravenous (Human)-ifas | Increased hypersensitivity reactions in patients receiving certain product lot | Voluntary Lot Withdrawals of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) for Increased Reports of Allergic/Hypersensitivity Reactions |
Parathyroid hormone
| Drug hypersensitivity | FDA is evaluating the need for regulatory action. |
| Proton pump inhibitors (PPIs) | Hearing loss | FDA is evaluating the need for regulatory action. |
Qulipta (atogepant) tablets Emgality (galcanezumab-gnlm) injection Aimovig (erenumab-aooe) injection Ajovy (fremanezumab-vfrm) injection Vyepti (eptinezumab-jjmr) injection Ubrelvy (ubrogepant) tablets Nurtec ODT (rimegepant) orally disintegrating tablets Zavzpret (zavegepant) nasal spray | Constipation | FDA is evaluating the need for regulatory action. |
| Sivextro (tedizolid phosphate) for injection; tablet | Serotonin syndrome | FDA is evaluating the need for regulatory action. |
| Symproic (naldemedine) tablets | Gastrointestinal perforation | FDA is evaluating the need for regulatory action. |
Valtrex (valacyclovir hydrochloride) tablets Zovirax (acyclovir) capsules; suspension; tablets | Severe cutaneous adverse reactions | FDA is evaluating the need for regulatory action. |
| Veozah (fezolinetant) tablets | Drug-induced liver injury | The “Boxed Warning”, “Dosage and Administration”, “Warnings and Precautions”, and “Patient Counseling Information” sections of the labeling were updated December 2024 to include information about hepatotoxicity. An FDA Drug Safety Communication was issued on September 12, 2024, and updated on December 20, 2024. |
| Vonjo (pacritinib) capsule | Acute kidney injury | FDA is evaluating the need for regulatory action. |
Xembify (Immune Globulin Subcutaneous, Human - klhw, 20%) | Increased hypersensitivity reactions in patients receiving certain product lots | Voluntary Lot Withdrawals of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) for Increased Reports of Allergic/Hypersensitivity Reactions |