January - March 2017 | 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 |
---|---|---|
|
Orlistat and neuropsychiatric adverse events |
Updated
FDA decided that no action is necessary at this time based on available information. |
|
Medication error |
The container labels and carton labeling were revised. In addition, the “Dosage and Administration” section of the labeling was updated to better differentiate the two formulations. |
|
Pediatric fever and dehydration |
Updated
The “Pediatric Use” and “Patient Counseling Information” sections of the Exjade and Jadenu labeling were updated in May 2018 to include pediatric fever and dehydration. |
Gonadotropin-releasing hormone (GnRH) Agonists
|
Musculoskeletal and connective tissue pain and discomfort |
FDA is evaluating the need for regulatory action. |
|
Acute kidney injury and interstitial nephritis |
The “Adverse Reactions; Postmarketing Experience” section of the labeling for Keppra and Keppra XR was updated to include acute kidney injury. Keppra labeling (tablets & oral solution) |
|
Ocular toxicities including vision loss and retinal detachment |
FDA is evaluating the need for regulatory action. |
Kybella (deoxycholic acid) injection, for subcutaneous use |
Injection site infection and necrosis |
Updated
The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Information” sections of the Kybella labeling were updated in January 2018 to include injection site infection and necrosis. |
Methimazole tablets |
Rhabdomyolysis in methimazole |
FDA decided that no action is necessary at this time, based on available information. |
Neulasta Onpro kit (pegfilgrastim) injection, for subcutaneous use |
Device failure |
Updated
The “Warnings and Precautions” section of the Neulasta Onpro kit labeling was updated in December 2017 to include device failure. |
Ofev (nintedanib) capsules, for oral use |
Liver dysfunction |
Updated
The “Warnings and Precautions” and “Adverse Reactions” sections of the Ofev labeling were updated in August 2017 to include liver dysfunction. |
Sodium-glucose cotransporter-2 (SGLT-2) inhibitors
|
Nephrolithiasis |
FDA decided that no action is necessary at this time, based on available information. |
Stelara (ustekinumab) injection, for subcutaneous use |
Interstitial pneumonia |
Updated
The “Warnings and Precautions” and “Adverse Reactions” sections of the Stelara labeling were updated in June 2018 to include interstitial pneumonia.
|
|
Serious hypersensitivity reactions |
Updated
The “Contraindications”, “Warnings and Precautions”, “Adverse Reactions”, “Medication Guide”, and “Patient Counseling Information” sections of the Tanzeum and Trulicity labeling were updated in August 2017 to include serious hypersensitivity reactions. |
Uloric (febuxostat) tablets, for oral use |
Drug reaction with Eosinophilia and Systemic Symptoms |
Updated
The “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information”, and “Patient Information” sections of the Uloric labeling were updated in February 2018 to include serious skin reactions. |