July – September 2022 | Potential Signals of Serious Risks/New Safety

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.

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

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

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

 

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

FDA determined that no action was necessary at the time based on available information.

Imuran (azathioprine)

Purinethol (mercaptopurine)

Purixan (mercaptopurine)

 

Tabloid (Thioguanine)*

Cholestasis of pregnancy

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

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

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

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

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

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

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

FDA determined that no action was necessary at the time based on available information.

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