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)

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 

• 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

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

• 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

Non-arteritic anterior ischemic optic neuropathy (NAION) FDA is evaluating the need for regulatory action.

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) 

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

• Bonsity (teriparatide injection)
• Forteo (teriparatide injection)
• Teriparatide injection
• Tymlos (abaloparatide) injection
• Yorvipath (palopegteriparatide) injection

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