January - March 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) |
|---|---|---|
| Addyi (flibanserin) | Accidental exposure to product by child |
Updated
FDA decided that no action is necessary at this time based on available information. |
Betadine (povidone-iodine) E-Z Prep (povidone-iodine) E-Z Prep 220 (povidone-iodine)
| Intentional product misuse | FDA decided that no action is necessary at this time based on available information. |
| Buphenyl (sodium phenylbutyrate) | Accidental overdose |
Updated
The “Overdosage” section of the labeling was updated in July 2022 to include information about overdoses. |
Lithium-containing products
Sodium-glucos co-transporter (SGLT) 2 inhibitors
| Sodium-glucose co-transporter 2 (SGLT2) inhibitor and lithium drug interaction |
Updated
The “Drug Interactions” section of the labeling for all SGLT2 inhibitors and lithium products was updated in October 2022 to include information about the risk of a drug-drug interaction. Example: Farxiga labeling |
HMG-CoA reductase inhibitors
| Drug reaction with eosinophilia and systemic symptoms (DRESS) |
Updated
The “Adverse Reactions” section of the labeling for Crestor, Ezallor Sprinkle and Roszet was updated between January 2023 and August 2024 to include information about DRESS. Example: Crestor labeling FDA determined that no action was necessary at the time based on available information for the other listed products. |
HMG-CoA reductase inhibitors
| Lichen planus |
Updated
The “Adverse Reactions” section of the labeling for Altoprev, Crestor, Ezallor Sprinkle, Lescol XL, Livalo, Nikita, Roszet, Vytorin, Zocor and Zypitamag was updated between May 2022 and August 2024 to include information about lichen planus. Example: Altoprev labeling FDA determined that no action was necessary at the time based on available information for Liptruzet, Caduet, and Lipitor. The “Adverse Reactions” section of the labeling for Flolipid does not include information about lichen planus at this time. |
HMG-CoA reductase inhibitors
| Immune-mediated myositis |
Updated
The “Warnings and Precautions” section of the labeling was updated between March 2022 and August 2024 to include information about immune-mediated necrotizing myopathy (IMNM) recurrence when the same or a different statin was administered.* Example: Liptruzet labeling * The labeling for Flolipid does not include the updated information about IMNM recurrence at this time. |
Kalydeco (ivacaftor) Orkambi (lumacaftor/ivacaftor) Symdeko (tezacaftor/ivacaftor) Trikafta (elexacaftor; tezacaftor; and ivacaftor)
| Anaphylactic reaction |
Updated
The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling were updated in August 2023 to include information about anaphylaxis. Example: Orkambi labeling |
| Ocrevus (ocrelizumab) | Progressive multifocal leukoencephalopathy |
Updated
The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling and the Medication Guide were updated in August 2022 to include information about progressive multifocal leukoencephalopathy. |
Octagam 10% [Immune Globulin Intravenous (Human)] | Increased hypersensitivity reactions in patients receiving certain product lots |
Updated
|
| Reblozyl (luspatercept-aamt) | Extramedullary hematopoietic (EMH) masses |
Updated
The “Dosage and Administration”, “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information”, and “Patient Information” sections of the labeling were updated in July 2022 to include information about extramedullary hematopoietic (EMH) masses.
|
Selective serotonin reuptake inhibitors (SSRI) and serotonin and norepinephrine reuptake (SNRI) inhibitors
| Anosmia |
Updated
The “Adverse Reactions” section of the labeling was updated between August 2023 and November 2024 to include information about anosmia. Example: Lexapro labeling |
Selective serotonin reuptake inhibitors (SSRI) and serotonin and norepinephrine reuptake (SNRI) inhibitors
| Hyposmia |
Updated
The “Adverse Reactions” section of the labeling was updated between August 2023 and November 2024 to include information about hyposmia. Example: Lexapro labeling |