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 |
Updated
The “Adverse Reactions” section of the labeling was updated in January 2020 and April 2020 to include thrombotic microangiopathy. |
|
Constipation |
Updated
The “Warnings and Precautions” section of the labeling for Aimovig was updated in October 2019 to include the risk of constipation with serious complications. FDA decided that no action is necessary at this time based on available information for Ajovy and Emgality. FDA is continuing to monitor the issue. |
|
Aseptic meningitis |
Updated
The “Adverse Reactions” section of the labeling was updated between March 2022 and November 2022 to include aseptic meningitis. Example: FDA withdrew approval for Prevpac in the Federal Register effective May 1, 2019. |
|
Solid organ transplant rejection |
Updated
The “Warnings and Precautions” section of the labeling was updated in November 2020 to include solid organ transplant rejection. |
Rubidium Rb 82 generators
|
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) |
|
Dysglycemia |
Updated
The “Drug Interactions” section of the labeling was updated between September 2019 and December 2019 to include information regarding altered blood glucose control resulting in hypoglycemia in patients with diabetes who received direct-acting antiviral drugs for the treatment of chronic hepatitis C virus infection. Example: Epclusa labeling FDA withdrew approval for Viekira XR and Technivie in the Federal Register effective February 7, 2020. Withdrawal of Approval for Viekira XR and Technivie. FDA withdrew approval for Viekira Pak in the Federal Register effective October 5, 2023. |
| Esbriet (pirfenidone) | Drug induced liver injury |
Updated
The “Warnings and Precautions” and “Adverse Reactions” sections of the labeling were updated in July 2019 to include drug-induced liver injury (DILI). |
| Forteo (teriparatide) | Cutaneous calcification, including calciphylaxis |
Updated
The “Warnings and Precautions” section of the labeling was updated in November 2020 to include cutaneous calcification including calciphylaxis. |
Updated
|
Wrong dose errors in pediatric patients |
Updated
FDA issued a postmarketing requirement (PMR) in October 2019 requiring Neulasta and biosimilars of Neulasta to submit pediatric assessments including developing an appropriate formulation (presentation) that can be dosed directly and accurately to pediatric patients. *An administrative error resulted in the omission of Udenyca from this signal and was added after the initial quarterly report was posted. |
|
Serious hepatotoxicity |
Updated
The “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information” sections of the labeling, and the “Medication Guide” were updated in August 2019 to include clinically significant liver injury, including acute liver failure requiring transplant, in patients treated with fingolimod. |
|
Brugada syndrome |
Updated
The “Warnings and Precautions” section of the labeling was updated in October 2020 to include the risk for cardiac rhythm and conduction abnormalities. Example: Lamictal labeling |
|
Hepatic decompensation and hepatic failure |
Updated
The “Dosage and Administration”, “Warnings and Precautions”, “Adverse Reactions”, “Use in Specific Populations”, and “Patient Counseling Information” sections of the labeling for Mavyret, Zepatier and Vosevi were updated between September 2019 and December 2019 to include information regarding the risk of hepatic decompensation and hepatic failure in patients treated with HCV NS3/4A protease inhibitor containing direct acting antiviral regimens. The “Contraindications” section of the labeling for Mavyret and Zepatier was updated between September 2019 and December 2019 to contraindicate the use in patients with moderate or severe hepatic impairment (Child-Pugh B or C) or those with any history of prior hepatic decompensation. An FDA Drug Safety Communication for Mavyret, Zepatier, and Vosevi was issued on August 28, 2019. |
| Non-steroidal anti-inflammatory drugs (NSAIDs) | Drug reaction with eosinophilia and systemic symptoms (DRESS) |
Updated
The “Warnings” and “Warnings and Precautions” sections of the labeling were updated in April 2021 to include drug reaction with eosinophilia and systemic symptoms (DRESS). Example: Mobic labeling |
| Pomalyst (pomalidomide) | Thyroid disorders |
Updated
The “Adverse Reactions” section of the labeling was updated in October 2019 to include hypothyroidism and hyperthyroidism. |
|
Ketoacidosis |
Updated
The “Warnings and Precautions” section of the labeling was updated in July 2020 for Signifor LAR to include ketoacidosis. The labeling for Signifor already contained appropriate information on risk of ketoacidosis and hyperglycemia; therefore, it was not updated. |
|
Ataxia and encephalopathy |
Updated
The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling for efavirenz-containing products were updated in October 2019 to include late-onset neurotoxicity, including ataxia and encephalopathy. Example: Symfi labeling The FDA withdrew approval for Sustiva tablets and capsules in the Federal Register effective May 23, 2024, and July 3, 2024, respectively. |
|
Hypofibrinogenemia |
Updated
The “Warnings and Precautions” and “Adverse Reactions” sections of the labeling were updated in 2020 to include hypofibrinogenemia. Example: Tygacil labeling |
Updated
|
Differentiation syndrome |
Updated
The “Adverse Reactions” section of the labeling was updated between February 2020 and July 2020 to include differentiation syndrome. Example: Vidaza labeling FDA withdrew approval for Dacogen in the Federal Register effective October 5, 2023. Withdrawal of Approval for Dacogen. *An administrative error resulted in the omission of Dacogen from the initial quarterly report. |
| Zydelig (idelalisib) | Heart failure | FDA decided that no action is necessary at this time based on available information. |