July - September 2025 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

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.

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.

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