
October - December 2024 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
Alecensa (alectinib) capsules
Alunbrig (brigatinib) tablets
Lorbrena (lorlatinib) tablets
Zykadia (ceritinib) capsules; tablets
Optic neuropathy FDA is evaluating the need for regulatory action.Antidepressants
- Selective serotonin reuptake inhibitors (SSRIs)
- Serotonin-norepinephrine reuptake inhibitors (SNRIs), including selective norepinephrine reuptake inhibitors
- Tricyclic antidepressants (TCAs)
- Monoamine oxidase inhibitors (MAOIs)
- Bupropion-containing products
- Mirtazapine-containing products
- Nefazodone-containing products
- Trazodone-containing products
- Vilazodone-containing products
- Trintellix (vortioxetine) tablets
- Atomoxetine-containing products
- Qelbree (viloxazine extended-release capsules)
- FDA-approved combination products containing one or more antidepressant(s)
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
- Children’s Zyrtec (cetirizine hydrochloride) chewable tablets
- Children’s Zyrtec Allergy (cetirizine hydrochloride) orally disintegrating tablet
- Children’s Zyrtec Hives (cetirizine hydrochloride) oral solution
- Cetirizine HCl capsules
- Xyzal (levocetirizine dihydrochloride) tablets; oral solution
- Xyzal Allergy 24HR (levocetirizine dihydrochloride) tablets; oral solution
- Zyrtec Allergy (cetirizine hydrochloride) orally disintegrating tablet
- Zyrtec-D (cetirizine HCl 5mg/ pseudoephedrine HCl 120mg)
- Zyrtec Hives (cetirizine hydrochloride) tablets
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
- Adlyxin (lixisenatide) injection
- Bydureon (exenatide) for extended-release injectable suspension
- Bydureon BCise (exenatide extended-release) injectable suspension
- Byetta (exenatide) injection
- Mounjaro (tirzepatide) injection
- Ozempic (semaglutide) injection
- Rybelsus (semaglutide) tablets
- Saxenda (liraglutide) injection
- Soliqua 100/33 (insulin glargine and lixisenatide) injection
- Trulicity (dulaglutide) injection
- Victoza (liraglutide) injection
- Wegovy (semaglutide) injection
- Xultophy 100/3.6 (insulin degludec and liraglutide) injection
- Zepbound (tirzepatide) injection
Gonadotropin releasing hormone (GnRH) agonists
- Eligard (leuprolide acetate) for injectable suspension
- Lupron (leuprolide acetate) injection
- Trelstar (triptorelin pamoate for injectable suspension)
- Vantas (histrelin acetate implant)
- Zoladex (goserelin implant)
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 ReactionsParathyroid hormone
- Bonsity (teriparatide injection)
- Forteo (teriparatide injection)
- Teriparatide injection
- Tymlos (abaloparatide) injection
- Yorvipath (palopegteriparatide) injection
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 injuryThe “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
Distribution channels: Healthcare & Pharmaceuticals Industry
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