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  5. Questions and Answers on FDA's Adverse Event Reporting System (FAERS)
  6. July - September 2022 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
  1. Questions and Answers on FDA's Adverse Event Reporting System (FAERS)

July - September 2022 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Product Name: Trade (Active Ingredient) or Product Class Potential Signal of a Serious Risk / New Safety Information Additional Information
(as of December 12, 2022)

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.

FDA is evaluating the need for regulatory action.

Amondys 45 (casimersen)

Hypersensitivity

FDA is evaluating the need for regulatory action.

Astagraf XL (tacrolimus)

Envarsus XR (tacrolimus)

Prograf (tacrolimus)

Prograf Granules (tacrolimus)

Drug interaction

FDA is evaluating the need for regulatory action.

Diskets (methadone hydrochloride)

Methadose (methadone hydrochloride)

Methadone Hydrochloride Injection

Hypoglycemia

 

FDA is evaluating the need for regulatory action.

Gilotrif (afatinib)

Iressa (gefitinib)

Tarceva (erlotinib)

Tagrisso (osimertinib)

Vizimpro (dacomitinib)

 

Radiation recall phenomenon

FDA is evaluating the need for regulatory action.

Imuran (azathioprine)

Purinethol (mercaptopurine)

Purixan (mercaptopurine)

Cholestasis of pregnancy

FDA is evaluating the need for regulatory action.

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)

Generic products containing octreotide acetate

Exocrine pancreatic function test abnormal

FDA is evaluating the need for regulatory action.

Lutathera (lutetium Lu 177 dotatate)

Pluvicto (lutetium Lu 177 vipivotide tetraxetan)

Tumour lysis syndrome

FDA is evaluating the need for regulatory action.

Lutathera (lutetium Lu 177 dotatate)

Pluvicto (lutetium Lu 177 vipivotide tetraxetan)

Extravasation

FDA is evaluating the need for regulatory action.

Certain naloxone hydrochloride product (generic product for the trade name Narcan)

Dose omission error associated with packaging confusion

FDA is evaluating the need for regulatory action.

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

FDA is evaluating the need for regulatory action.

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

FDA is evaluating the need for regulatory action.

Vizimpro (dacomitinib)

Hepatic and hepatobiliary disorders

FDA is evaluating the need for regulatory action.
 
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