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 June 12, 2020) |
|---|---|---|
|
Bridion (sugammadex) injection |
Arteriospasm coronary (coronary vasospasm) |
FDA is evaluating the need for regulatory action. |
|
|
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. |
|
CNS stimulants and atomoxetine
|
Drug interaction between CNS stimulants or atomoxetine and concomitant use of antipsychotics resulting in hyperkinetic movements |
FDA is evaluating the need for regulatory action. |
|
Eucrisa (crisaborole) |
Contact dermatitis |
The “Adverse Reactions” section of the Eucrisa labeling was updated in March 2020 to include allergic contact dermatitis. |
|
Lipiodol (ethiodized oil) |
Hypothyroidism |
FDA is evaluating the need for regulatory action. |
|
Plaquenil (hydroxychloroquine sulfate) |
Phospholipidosis |
FDA is evaluating the need for regulatory action. |
|
Proton pump inhibitors
|
Syndrome of inappropriate antidiuretic hormone secretion (SIADH) |
FDA is evaluating the need for regulatory action. |
|
Solosec (secnidazole) |
Alcohol interaction |
FDA is evaluating the need for regulatory action. |
|
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. |
|
Tysabri (natalizumab) |
Thrombocytopenia |
FDA is evaluating the need for regulatory action. |
|
Vascular endothelial grown factor (VEGF) inhibitors
|
Aneurysm and artery dissection |
FDA is evaluating the need for regulatory action. |
|
Xiaflex (collagenase clostridium histolyticum) |
Skin necrosis |
FDA is evaluating the need for regulatory action. |
|
Yervoy (ipilimumab) |
Hemophagocytic lymphohistiocytosis |
FDA is evaluating the need for regulatory action. |
|
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 (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. |