January - March 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 June 24, 2025)
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.