October - December 2018 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
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Product Name: Trade (Active Ingredient) or Product Class |
Potential Signal of a Serious Risk / New Safety Information |
Additional Information |
|---|---|---|
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Aimovig (erenumab-aooe) injection |
Hypersensitivity events |
The “Contraindications” and “Warnings and Precautions” sections of the labeling were updated to include information about hypersensitivity reactions. |
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Acute generalized exanthematous pustulosis, Drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome, and toxic epidermal necrolysis |
FDA is evaluating the need for regulatory action. |
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Medication errors: wrong drug |
FDA is evaluating the need for regulatory action. |
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Interstitial lung disease |
FDA is evaluating the need for regulatory action. |
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Drug-induced dental caries |
FDA is evaluating the need for regulatory action. |
|
Bosulif (bosutinib monohydrate) film |
Cardiac failure |
FDA is evaluating the need for regulatory action. |
|
Chlorpromazine hydrochloride |
Drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome, and toxic epidermal necrolysis |
FDA is evaluating the need for regulatory action. |
|
Cinvanti (aprepitant) injection |
Hypersensitivity reactions, including anaphylaxis |
The “Contraindications” and “Warnings and Precautions” sections of the labeling were updated to reflect information about hypersensitivity reactions. |
|
Stevens-Johnson syndrome and toxic epidermal necrolysis |
FDA decided that no action is necessary at this time. |
|
Gilenya (fingolimod) capsule |
Hemolytic anemia |
FDA is evaluating the need for regulatory action. |
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Respiratory depression |
FDA is evaluating the need for regulatory action. |
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Bullous pemphigoid |
FDA is evaluating the need for regulatory action. |
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Acute generalized exanthematous pustulosis, Drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome, and toxic epidermal necrolysis |
FDA is evaluating the need for regulatory action. |
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Drug interaction between axitinib and warfarin |
FDA is evaluating the need for regulatory action. |
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Drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome, and toxic epidermal necrolysis |
FDA is evaluating the need for regulatory action. |
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Acute generalized exanthematous pustulosis, Drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome and toxic epidermal necrolysis |
FDA is evaluating the need for regulatory action. |
|
Device malfunction |
FDA is evaluating the need for regulatory action. |
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Acute generalized exanthematous pustulosis, Drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome and toxic epidermal necrolysis |
FDA is evaluating the need for regulatory action. |
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Pyoderma gangrenosum |
FDA is evaluating the need for regulatory action. |
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Drug interaction between calcimimetics (i.e. cinacalcet hydrochloride or etelcalcetide) and denosumab |
FDA is evaluating the need for regulatory action. |
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Acute generalized exanthematous pustulosis, Drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome and toxic epidermal necrolysis |
FDA is evaluating the need for regulatory action. |
|
Stivarga (regorafenib) tablet |
Cardiac failure |
FDA is evaluating the need for regulatory action. |
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Aortic dissection |
FDA is evaluating the need for regulatory action. |
|
Tagrisso (osimertinib) tablet |
Severe cutaneous adverse events (SCAR): Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, and bullous pemphigoid |
FDA decided that no action is necessary at this time. |
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Acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis |
FDA is evaluating the need for regulatory action. |
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QT prolongation |
FDA is evaluating the need for regulatory action. |