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. |
|
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. |
|
Medication errors: wrong drug |
Updated
FDA decided that no action is necessary at this time based on available information. |
|
Interstitial lung disease |
Updated
The “Adverse Reactions” section of the fenofibrate labeling was updated between March 2019 and May 2019 to include interstitial lung disease. Example: Antara labeling |
|
Drug-induced dental caries |
FDA is evaluating the need for regulatory action. |
|
Bosulif (bosutinib monohydrate) film |
Cardiac failure |
Updated
The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the Bosulif labeling were updated in October 2019 to include cardiac failure. |
|
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 |
Updated
The “Adverse Reactions” section of the Gilenya labeling was updated in December 2019 to include hemolytic anemia. |
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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 |
Updated
FDA decided that no action is necessary at this time based on available information. |
|
Drug interaction between axitinib and warfarin |
Updated
FDA decided that no action is necessary at this time based on available information. |
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Drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome, and toxic epidermal necrolysis |
Updated
FDA decided that no action is necessary at this time based on available information. |
|
Acute generalized exanthematous pustulosis, Drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome and toxic epidermal necrolysis |
Updated
The “Adverse Reactions” section of the lithium labeling was updated in February 2020 to include drug reaction with eosinophilia and systemic symptoms. Example: Lithobid labeling
|
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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. |
|
Pyoderma gangrenosum |
Updated
The “Adverse Reactions” section of the rituximab labeling was updated between November 2019 and December 2019 to include pyoderma gangrenosum. |
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Drug interaction between calcimimetics (i.e. cinacalcet hydrochloride or etelcalcetide) and denosumab |
Updated
The “Dosage and Administration” and “Warnings and Precautions” sections of the Sensipar labeling were updated in March 2019 to include that the concomitant use of other serum calcium lowering drugs may worsen hypocalcemia risk. The “Warnings and Precautions” and “Adverse Reactions” sections of the Parsabiv labeling were updated in March 2019 to include that the concomitant use of other serum calcium lowering drugs may worsen hypocalcemia risk. The “Warnings and Precautions” section of the denosumab labeling was updated between April 2019 and February 2020 include that the concomitant use of calcimimetic drugs may worsen hypocalcemia risk. The “Warnings and Precautions” section of the Xgeva labeling was updated in February 2020 to include that the concomitant use of calcimimetic drugs may worsen hypocalcemia risk. |
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Acute generalized exanthematous pustulosis, Drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome and toxic epidermal necrolysis |
Updated
The “Adverse Reactions” section of the quetiapine labeling was updated in February 2020 to include acute generalized exanthematous pustulosis. |
|
Stivarga (regorafenib) tablet |
Cardiac failure |
Updated
The “Adverse Reactions” section of the Stivarga labeling was updated in July 2019 to include cardiac failure. |
|
Aortic dissection |
Updated
FDA decided that no action is necessary at this time based on available information. (See the January – March 2020 posting for safety information related to VEGF inhibitors and Aneurysm and Artery Dissection) |
|
Tagrisso (osimertinib) tablet |
Severe cutaneous adverse events (SCAR): Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, and bullous pemphigoid |
Updated
The “Dosage and Administration”, “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the Tagrisso labeling were updated in December 2019 to include Stevens-Johnson syndrome and erythema multiforme. |
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Acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis |
Updated
FDA decided that no action is necessary at this time based on available information. |
|
QT prolongation |
Updated
The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the Zytiga and Yonsa labeling were updated in June 2019 and September 2020, respectively, to include QT prolongation. |