July - September 2025 | 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 December 18, 2025)
ADZYNMA (ADAMTS13, recombinant-krhn)	Neutralizing antibodies with fatal outcome	FDA is evaluating the need for regulatory action. FDA Safety Communication was issued on November 21, 2025: FDA Investigating Death Due to Neutralizing Antibodies to ADAMTS13 following Adzynma Treatment of Congenital Thrombotic Thrombocytopenic Purpura
Asceniv (immune globulin intravenous, human-slra)	Increased hypersensitivity reactions in patients receiving certain product lot	FDA is evaluating the need for regulatory action. FDA Safety Communication was issued on October 28, 2025: Immune Globulin Intravenous (IGIV) and/or Immune Globulin Subcutaneous (IGSC) Lots with Increased Reports of Allergic/Hypersensitivity Reactions
Benlysta (belimumab) injection	Severe cutaneous adverse reactions	FDA is evaluating the need for regulatory action.
Braftovi (encorafenib) capsules Tafinlar (dabrafenib) capsules; tablets Zelboraf (vemurafenib) tablet	Sarcoidosis	FDA is evaluating the need for regulatory action.
Cabometyx (cabozantinib) tablets Cometriq (cabozantinib) capsules Lenvima (lenvatinib) capsules	Thrombotic microangiopathy	FDA is evaluating the need for regulatory action.
Cotellic (cobimetinib) tablets Mekinist (trametinib) tablets; oral solution Mektovi (binimetinib) tablets	Sarcoidosis	FDA is evaluating the need for regulatory action.
ELEVIDYS (delandistrogene moxeparvovec-rokl)	Mesenteric vein thrombosis following product-related acute liver injury	The "Warnings and Precautions" and "Adverse Reactions - Postmarketing Experience" sections of the labeling for Elevidys were updated in November 2025 to include life-threatening mesenteric vein thrombosis. Package Insert - ELEVIDYS Medication Guide - ELEVIDYS FDA Safety Communication was issued on November 14, 2025: FDA Takes Action on New Boxed Warning for Acute Serious Liver Injury and Acute Liver Failure Following Treatment with Elevidys and Revised Indication that is Limited to Ambulatory Duchenne Muscular Dystrophy Patients
Firmagon (degarelix for injection) Myfembree (relugolix, estradiol, and norethindrone acetate) tablets Orgovyx (relugolix) tablets	Drug interaction	FDA is evaluating the need for regulatory action.
Ifex (ifosfamide) injection	Pregnancy, puerperium and perinatal conditions	FDA is evaluating the need for regulatory action.
Ogsiveo (nirogacestat) tablets	Visual impairment	FDA is evaluating the need for regulatory action.
Orgovyx (relugolix) tablets	Hypertension	FDA is evaluating the need for regulatory action.
Rezzayo (rezafungin for injection)	Hypersensitivity	The "Warnings and Precautions", "Adverse Reactions" and "Patient Counseling Information" sections of the labeling were updated in December 2025 to include information about hypersensitivity reactions, including anaphylaxis.   Rezzayo labeling
Septocaine (articaine hydrochloride and epinephrine injection) Mepivacaine hydrochloride injection (a particular generic product)	Wrong drug administered	FDA is evaluating the need for regulatory action.