January – March 2025 | Potential Signals of Serious Risks/New Safety I

ELEVIDYS (delandistrogene moxeparvovec-rokl)

 

Hepatotoxicity-associated fatalities in non-ambulatory patients with Duchenne muscular dystrophy

FDA is evaluating the need for regulatory action.

FDA Safety Communication was issued on June 24, 2025:

FDA Investigating Deaths Due to Acute Liver Failure in Non-ambulatory Duchenne Muscular Dystrophy Patients Following ELEVIDYS

Finasteride (compounded product) topical Adverse event FDA alerts health care providers, compounders and consumers of potential risks associated with compounded topical finasteride products Janus kinase (JAK) inhibitors Cerebral venous sinus thrombosis FDA is evaluating the need for regulatory action. Leqembi (lecanemab-irmb) injection Amyloid related imaging abnormality-edema/effusion FDA is evaluating the need for regulatory action. Ocaliva (obeticholic acid) tablets Liver disorder FDA is evaluating the need for regulatory action.

Olanzapine-containing products

• Lybalvi (olanzapine and samidorphan) tablets
• Symbyax (olanzapine and fluoxetine) capsules
• Zyprexa (olanzapine) tablets
• Zyprexa Intramuscular (olanzapine) injection
• Zyprexa Relprevv (olanzapine) injectable suspension
• Zyprexa Zydis (olanzapine) tablets

 

Inappropriate antidiuretic hormone secretion FDA is evaluating the need for regulatory action.

Poly (ADP-ribose) polymerase (PARP) inhibitors

• Akeega (niraparib and abiraterone acetate) tablets
• Lynparza (olaparib) tablets
• Rubraca (rucaparib) tablets
• Talzenna (talazoparib) capsules
• Zejula (niraparib) tablets

 

Vasculitis FDA is evaluating the need for regulatory action.

Rilutek (riluzole) tablets

Tiglutik (riluzole) oral suspension

Pancreatitis acute FDA is evaluating the need for regulatory action. Suprep Bowel Pre Kit (sodium sulfate, potassium sulfate, and magnesium sulfate) oral solution Hypersensitivity FDA is evaluating the need for regulatory action.

Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) injection

 

Severe worsening of chronic inflammatory demyelinating polyradiculoneuropathy FDA is evaluating the need for regulatory action. Xcopri (cenobamate tablets) Drug-induced liver injury FDA is evaluating the need for regulatory action.

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