July - September 2017 | Potential Signals of Serious Risks/New Safety Information Identified from 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 |
---|---|---|
Actemra (tocilizumab) injection, for intravenous and subcutaneous use |
Tocilizumab and pancreatitis |
FDA is evaluating the need for regulatory action. |
Actemra (tocilizumab) injection, for intravenous or subcutaneous use |
Tocilizumab and hepatotoxicity |
FDA is evaluating the need for regulatory action. |
|
Serious skin reactions |
FDA is evaluating the need for regulatory action. |
|
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) |
FDA is evaluating the need for regulatory action. |
|
Hypoglycemic coma |
FDA is evaluating the need for regulatory action. |
|
Rebound Pruritis |
FDA is evaluating the need for regulatory action. |
Pseudoephedrine |
Acute generalized exanthematous pustulosis |
FDA is evaluating the need for regulatory action. |
Imbruvica (ibrutinib) capsules, for oral use |
Hepatotoxicity |
FDA is evaluating the need for regulatory action. |
Imbruvica (ibrutinib) capsules, for oral use |
Ventricular arrhythmia |
The “Warnings and Precautions” section of the labeling for Imbruvica was updated to include ventricular arrhythmia. |
|
Drug interaction with nitrous oxide - potentiated effect of methotrexate on folate metabolism, resulting in increased toxicity (severe myelosuppression, stomatitis, and neurotoxicity) |
FDA is evaluating the need for regulatory action. |
Nafcillin Injection, USP, for intravenous use only |
Acute renal failure |
FDA is evaluating the need for regulatory action. |
Ocaliva (obeticholic acid) tablets, for oral use |
Liver injury |
FDA is evaluating the need for regulatory action. |
|
Wrong dosing frequency errors (once daily administration instead of intended once weekly schedule) |
FDA is evaluating the need for regulatory action. |
Soliris (eculizumab) injection, for intravenous use |
Nongroupable meningitis infections and Neisseria (other than N. meningitides) infections |
FDA is evaluating the need for regulatory action. |
Uptravi (selexipag) tablets, for oral use |
Hypotension |
The “Adverse Reactions: Postmarketing Experience” section of the labeling for Uptravi was updated to include hypotension. |
Vraylar (cariprazine) capsules, for oral use |
Stevens-Johnson syndrome (SJS) |
FDA is evaluating the need for regulatory action. |
Xarelto (rivaroxaban) tablets, for oral use |
Liver injury |
FDA decided that no action is necessary at this time based on available information. |