January - March 2019 | Potential Signals of Serious Risks/New Safety Information Identified from 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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Thrombotic microangiopathy | FDA is evaluating the need for regulatory action. |
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Constipation | FDA is evaluating the need for regulatory action. |
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Aseptic meningitis | FDA is evaluating the need for regulatory action. |
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Solid organ transplant rejection | FDA is evaluating the need for regulatory action. |
Rubidium Rb 82 generators
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Excess radiation exposure to the patient due to elution of the generator with an incorrect solution containing calcium | The “Boxed Warning”, “Dosing and Administration,” “Contraindications,” and “Warnings and Precautions,” sections on labeling were updated to include information about using the correct solution to elute the generator and carefully following daily safety procedures for the system. Rubidium Rb 82 generator Drug Safety Communication (4/29/19) |
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Dysglycemia | FDA is evaluating the need for regulatory action. |
| Esbriet (pirfenidone) | Drug Induced Liver Injury | FDA is evaluating the need for regulatory action. |
| Forteo (teriparatide) | Cutaneous calcification, including calciphylaxis | FDA is evaluating the need for regulatory action. |
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Wrong dose errors in pediatric patients | FDA is evaluating the need for regulatory action. |
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Serious hepatotoxicity | FDA is evaluating the need for regulatory action. |
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Brugada Syndrome | FDA is evaluating the need for regulatory action. |
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Hepatic decompensation and hepatic failure | FDA is evaluating the need for regulatory action. |
| Non-steroidal anti-inflammatory drugs (NSAIDs) | Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) | FDA is evaluating the need for regulatory action. |
| Pomalyst (pomalidomide) | Thyroid disorders | FDA is evaluating the need for regulatory action. |
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Ketoacidosis | FDA is evaluating the need for regulatory action. |
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Ataxia and encephalopathy | FDA is evaluating the need for regulatory action. |
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Hypofibrinogenemia | FDA is evaluating the need for regulatory action. |
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Differentiation syndrome | FDA is evaluating the need for regulatory action. |
| Zydelig (idelalisib) | Heart failure | FDA decided that no action is necessary at this time based on available information. |