July - September 2022 | 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 October 24, 2025)
Allergenic Extract – Peanut (Arachis hypogaea) - For Diagnostic Use Only, manufactured by ALK-Abelló, Inc.	Certain product lots were associated with increased reports of false negative skin test results, with some cases of anaphylaxis from subsequent peanut exposure.	Updated Voluntary Lot Withdrawals of Allergenic Extract – Peanut (Arachis hypogaea)- For Diagnostic Use Only, Manufactured by ALK-Abelló, Inc. for Increased Reports of False Negative Test Results All Allergenic Extracts for Diagnosis of Food Allergy: FDA Safety Communication - FDA Requires Warning about Anaphylaxis Following False Negative Food Allergen Skin Test Results in the Prescribing Information \| FDA
Amondys 45 (casimersen)	Hypersensitivity	Updated The “Dosage and Administration”, “Contraindications”, “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling were updated in March 2023 to include information about hypersensitivity. Amondys 45 labeling
Astagraf XL (tacrolimus) Envarsus XR (tacrolimus) Prograf (tacrolimus) Prograf Granules (tacrolimus)	Drug interaction	Updated The “Warnings and Precautions” and “Drug Interactions” sections of the labeling and Medication Guide were updated in September 2023 to include information about drug interactions. Example: Prograf labeling
Diskets (methadone hydrochloride) Methadose (methadone hydrochloride) Methadone Hydrochloride Injection	Hypoglycemia	Updated The “Warnings and Precautions”, “Adverse Reactions”, “Overdosage”, and “Patient Counseling Information” sections of the labeling were updated in December 2023 to include information about hypoglycemia. Example: Diskets labeling
Gilotrif (afatinib) Iressa (gefitinib) Tarceva (erlotinib) Tagrisso (osimertinib) Vizimpro (dacomitinib)	Radiation recall phenomenon	Updated FDA determined that no action was necessary at the time based on available information.
Imuran (azathioprine) Purinethol (mercaptopurine) Purixan (mercaptopurine) Updated Tabloid (Thioguanine)*	Cholestasis of pregnancy	Updated The “Warnings and Precautions” and “Adverse Reactions” sections of the labeling were updated in July 2024 to include information about cholestasis of pregnancy. Example: Imuran labeling *An administrative error resulted in the omission of Tabloid from the list of product names and was added after the initial quarterly report was posted.
Kesimpta (ofatumumab) Ocrevus (ocrelizumab)	Infection	FDA is evaluating the need for regulatory action.
Lanreotide Mycapssa (octreotide) Sandostatin (octreotide acetate) Sandostatin LAR Depot (octreotide acetate) Signifor (pasireotide) Signifor LAR (pasireotide) Somatuline Depot (lanreotide)	Exocrine pancreatic function test abnormal	Updated The “Warnings and Precautions” and “Adverse Reactions” sections of the labeling was updated in July 2024 to include information about pancreatic exocrine insufficiency. Example: Lanreotide labeling
Lutathera (lutetium Lu 177 dotatate) Pluvicto (lutetium Lu 177 vipivotide tetraxetan)	Tumor lysis syndrome	Updated FDA determined that no action was necessary at the time based on available information.
Lutathera (lutetium Lu 177 dotatate) Pluvicto (lutetium Lu 177 vipivotide tetraxetan)	Extravasation	Updated The “Dosage and Administration” section of the labeling for Lutathera was updated in April 2024 to include information about extravasation. Lutathera labeling FDA has determined that the last approved labeling for Pluvicto is adequately labeled for extravasation, and that no further regulatory action was necessary at the time.
Certain naloxone hydrochloride product (generic product for the trade name Narcan)	Dose omission error associated with packaging confusion	Updated The carton labeling and insert labeling were revised in May and June 2023 to include information to minimize the risk of dose omission errors.
Certain neostigmine methylsulfate product (generic product for the trade name Bloxiverz) Certain phenylephrine hydrochloride product (generic product for the trade name Vazculep)	Risk of wrong drug medication errors associated with look-alike neostigmine and phenylephrine container labels	The container label and carton labeling for neostigmine methylsulfate was revised in November 2022 to differentiate the product from phenylephrine hydrochloride.
Ocrevus (ocrelizumab)	Pyoderma gangrenosum	Updated The “Adverse Reactions” section of the labeling was updated in August 2023 to include information about pyoderma gangrenosum. Ocrevus labeling
Certain potassium chloride for injection concentrate product (generic product)	Risk of medication errors associated with packaging change from glass bottle to plastic bag	The container label and package insert labeling was revised in December 2022 to mitigate the potential for medication errors.
Rydapt (midostaurin)	Acute febrile neutrophilic dermatosis	Updated The “Adverse Reactions” section of the labeling was updated in May 2023 to include information about acute febrile neutrophilic dermatosis. Rydapt labeling
Vizimpro (dacomitinib)	Hepatic and hepatobiliary disorders	Updated FDA determined that no action was necessary at the time based on available information.