January - March 2020 | 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 January 31, 2025) |
|---|---|---|
| Bridion (sugammadex) injection | Arteriospasm coronary (coronary vasospasm) |
Updated
The “Adverse Reactions” section of the labeling was updated in January 2021 to include coronary spasm. |
| Thrombocytopenia | The “Contraindications,” "Warnings and Precautions," “Adverse Reactions,” “Patient Counseling Information,” and “Medication Guide,” sections of the exenatide labeling were updated in February 2020 to include thrombocytopenia. Example: Bydureon labeling |
Central Nervous System (CNS) stimulants and atomoxetine
| Drug interaction between CNS stimulants or atomoxetine and concomitant use of antipsychotics resulting in hyperkinetic movements |
Updated
The “Drug Interactions” section of methylphenidate and dexmethylphenidate labeling were updated in June 2021 and July 2021 to include information about monitoring for signs of extrapyramidal symptoms (EPS) with the combined use of risperidone. Example: Concerta labeling |
| Eucrisa (crisaborole) | Contact dermatitis | The “Adverse Reactions” section of the Eucrisa labeling was updated in March 2020 to include allergic contact dermatitis. Eucrisa labeling |
| Lipiodol (ethiodized oil) | Hypothyroidism |
Updated
The “Warnings and Precautions”, “Adverse Reactions”, and “Use in Specific Populations” sections of the labeling were updated in June 2020 to include information about hypothyroidism. |
| Plaquenil (hydroxychloroquine sulfate) Generic products containing hydroxychloroquine | Phospholipidosis |
Updated
The “Warnings and Precautions” section of the labeling was updated in May 2022 to include information about phospholipidosis. |
Proton pump inhibitors
Updated
| Syndrome of inappropriate antidiuretic hormone secretion (SIADH) |
Updated
The “Warnings and Precautions” and “Adverse Reactions” sections of the labeling were updated in March 2022 to include information about hyponatremia. Example: Protonix labeling *An administrative error resulted in the omission of Prilosec from the initial quarterly report. |
| Solosec (secnidazole) | Alcohol interaction |
Updated
The “Adverse Reactions”, “Drug Interactions”, and “Patient Counseling Information” sections of the labeling were updated in June 2021 to include information about interaction with alcohol. |
| Trogarzo (ibalizumab-uiyk) | Anaphylactic Reaction | The “Contraindications,” “Warnings and Precautions,” “Adverse Reactions,” “Patient Counseling Information,” and “Patient Information”sections of the Trogarzo labeling were updated in April 2020 to include hypersensitivity reactions including infusion-related reactions and anaphylactic reactions. Trogarzo labeling |
| Tysabri (natalizumab) | Thrombocytopenia |
Updated
The “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information”, and “Medication Guide” sections of the labeling were updated in June 2020 to include information about thrombocytopenia. |
Vascular endothelial growth factor (VEGF) inhibitors
| Aneurysm and artery dissection |
Updated
The “Adverse Reactions” section of the labeling was updated between June 2020 and April 2021 to include arterial (including aortic) aneurysms, dissections, and rupture. Example: Inlyta labeling FDA determined that no action is necessary at this time for Ofev based on available information. FDA is continuing to monitor the issue. |
| Xiaflex (collagenase clostridium histolyticum) | Skin necrosis |
Updated
The “Warnings and Precautions” section of the labeling was updated in August 2021 to include information about skin necrosis. |
| Yervoy (ipilimumab) | Hemophagocytic lymphohistiocytosis |
Updated
The “Adverse Reactions” section of the labeling was updated in August 2020 to include hemophagocytic lymphohistiocytosis (HLH). |
| Zonegran (zonisamide) | Acute myopia and secondary angle closure glaucoma | The "Warnings,” “Information for Patients,” “Pediatric Use,” “Adverse Reactions; Postmarketing Experience,” and “Medication Guide” sections of the Zonegran labeling were updated in April 2020 to include acute myopia and secondary angle closure glaucoma. Zonegran labeling |
| Zonegran (zonisamide) | Hyperammonemia and encephalopathy | The "Warnings,” “Clinical Pharmacology,” “Information for Patients,” “Pediatric Use,” “Adverse Reactions; Postmarketing Experience,” and “Medication Guide” sections of the Zonegran labeling were updated in April 2020 to include hyperammonemia and encephalopathy. Zonegran labeling |