| 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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