July - September 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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Atypical antipsychotics and serotonin syndrome |
FDA is evaluating the need for regulatory action.
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Amphetamines and amphetamine congeners for management of obesity
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Death and sudden death |
FDA is evaluating the need for regulatory action. |
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Injectible insulins and insulin analogs |
Cutaneous amyloidosis |
FDA is evaluating the need for regulatory action. |
|
Central sleep apnea associated with the use of ticagrelor |
FDA is evaluating the need for regulatory action. |
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Rhabdomyolysis due to Drug-Drug Interaction between |
FDA is evaluating the need for regulatory action. |
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Hemophagocytic Lymphohistiocytosis (HLH) |
FDA decided that no action is necessary at this time based on available information. |
|
Stroke, intracranial hemorrhage, and/or cervicocephalic arterial dissection |
The “Boxed Warning” section of labeling was updated to include the risk of stroke. The “Warnings and Precautions” section of labeling was updated to include the risk of stroke and cervicocephalic arterial dissection. |
|
Daptomycin injection |
Infusion - related reactions |
Eight drug product lots released to the market and within expiry were recalled voluntarily, with FDA’s agreement, up to the Hospital/Retail level, effective 6/29/2018, as published on FDA’s website. |
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Acute kidney injury |
FDA is evaluating the need for regulatory action. |
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Hypersensitivity |
FDA is evaluating the need for regulatory action. |
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Intravenous iron replacement products
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Fatal and severe hypersensitivity reactions |
FDA is evaluating the need for regulatory action. |
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Pegfilgrastim injection products |
Alveolar hemorrhage, hemoptysis |
FDA is evaluating the need for regulatory action.
|
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Ocrevus (ocrelizumab) injection |
Anaphylaxis |
FDA is evaluating the need for regulatory action. |
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PCSK9 Inhibitors
|
Influenza-like illness |
The “Postmarketing Experience” section of labeling was updated to include flu-like illness. |
|
Phenol |
Serious adverse events associated with teething |
FDA is evaluating the need for regulatory action. |
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Proton Pump Inhibitors
|
Rebound acid hypersecretion |
FDA decided that no action is necessary at this time based on available information. |
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Rituxan Hycela (rituximab and hyaluronidase human) injection, and rituximab for injection products |
Incorrect route of administration |
FDA is evaluating the need for regulatory action. |
|
Xifaxan (rifaximin) tablets |
Rhabdomyolysis |
FDA is evaluating the need for regulatory action. |