April - June 2020 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
| Product Name: Trade (Active Ingredient) or Product Class | Potential Signal of a Serious Risk / New Safety Information | Additional Information (as of January 31, 2025) |
|---|---|---|
| Aimovig (erenumab-aooe) | Wrong strength | FDA decided that no action is necessary at this time based on available information. |
| Aimovig (erenumab-aooe) | Product preparation error |
Updated
The carton labeling, “Dosage and Administration”, “Patient Counseling Information”, “Patient Information”, and “Instructions for Use” sections of the labeling were updated in February 2021 to include guidance on how to prepare the product. |
| Ajovy (fremanezumab-vfrm) Aimovig (erenumab-aooe) Emgality (galcanezumab-gnlm) Vyepti (eptinezumab-jjmr) | Stevens-Johnson syndrome (SJS) |
Updated
FDA determined that no action is necessary at this time based on the available information. FDA is continuing to monitor this issue. |
| Aubagio (teriflunomide) Generic products containing teriflunomide | Drug reaction with eosinophilia and systemic symptoms (DRESS) |
Updated
The “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information”, and “Medication Guide” sections of the labeling were updated in November 2020 to include information about drug reaction with eosinophilia and systemic symptoms (DRESS). |
| Darzalex (daratumumab) Darzalex Faspro (daratumumab and hyaluronidase-fihj) | Listeriosis |
Updated
The “Adverse Reactions” section of the labeling was updated in March 2021 to include listeriosis. Example: Darzalex labeling |
| Erleada (apalutamide) | Toxic epidermal necrolysis |
Updated
The “Adverse Reactions” section of the labeling was updated in September 2020 to include toxic epidermal necrolysis and Stevens-Johnson syndrome. |
Fibric acid derivatives
| Drug-induced liver injury |
Updated
The “Warnings and Precautions”, "Adverse Reactions", and "Patient Counseling Information” sections of the labeling were updated in June 2021 to include information about hepatotoxicity. Example: Tricor labeling |
Glucagon-like peptide 1 (GLP-1) Receptor Agonists
| Hypoglycemia |
Updated
The “Warnings and Precautions”, “Drug Interactions”, “Patient Counseling Information”, and “Medication Guide” sections of the labeling for Adlyxin, Bydureon, Bydureon BCise, Byetta, Ozempic, Rybelsus, Saxenda, Trulicity, and Victoza were updated between November 2020 and September 2021 to include information about hypoglycemia. Example: Trulicity labeling FDA has determined that the last approved labeling is adequate, and that no further regulatory action is needed at this time for Soliqua, and Xultophy based on the available information. Additional information is not provided for Tanzeum because the biologics license for this product was voluntarily revoked by FDA, at the license holder’s request, prior to the labeling updates referenced above. |
| Ibrance (palbociclib) | Stevens-Johnson syndrome |
Updated
FDA determined that no action is necessary at this time based on available information. FDA is continuing to monitor this issue. |
| Kadcyla (ado-trastuzumab emtansine) | Skin vascular abnormalities (e.g., telangiectasia, spider nevus, spider angioma) | FDA decided that no action is necessary at this time based on available information. |
| Kisqali (ribociclib) Kisqali Femara co-pack (ribociclib, letrozole) | Stevens-Johnson syndrome |
Updated
The “Warnings and Precautions”, “Dosage and Administration”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling were updated in July 2020 to include information about severe cutaneous adverse reactions. Example: Kisqali labeling |
| Lipitor (atorvastatin) | Drug interaction between atorvastatin and hepatitis C virus (HCV) NS5A/NS5B inhibitors |
Updated
The “Dosage and Administration” and “Warnings and Precautions” sections of the labeling were updated in November 2020 to communicate the risk of potential drug interaction and mitigation information. |
Mammalian target of rapamycin (mTOR) inhibitors
| Radiation recall phenomenon |
Updated
The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the Afinitor and Afinitor Disperz labeling were updated in April 2021 to include information about radiation recall. Example: Afinitor labeling FDA determined that no action is necessary at this time for Torisel and temsirolimus containing products based on the available information. |
| Nuzyra (omadacycline tosylate) | Wrong dose | FDA decided that no action is necessary at this time based on available information. |
| Ocaliva (obeticholic acid) | Liver disorder |
Updated
The “Boxed Warning”, “Indications and Usage”, “Dosage and Administration”, “Contraindications”, “Warnings and Precautions”, “Use in Specific Populations”, “Patient Counseling Information”, and “Medication Guide” sections of the labeling were updated in May 2021 to state that Ocaliva should not be used in primary biliary cholangitis patients with decompensated cirrhosis or compensated cirrhosis with clinical evidence of portal hypertension. An FDA Drug Safety Communication for Ocaliva was issued on May 26, 2021. |
| Ocrevus (ocrelizumab) | Hepatitis B reactivation |
Updated
The “Dosage and Administration”, “Warnings and Precautions”, “Adverse Reactions”, “Use in Specific Populations”, and “Medication Guide” sections of the labeling were updated in November 2020 to include recommendations that testing for quantitative serum immunoglobulins be performed prior to initiating, hepatitis B virus reactivation, pregnancy exposure registry information, and the risk for decreased immunoglobulins and serious infections. |
| Plaquenil (hydroxychloroquine sulfate) Chloroquine phosphate Generic products containing hydroxychloroquine and chloroquine | Cardiotoxicity |
Updated
The “Warnings and Precautions”, “Adverse Reactions”, “Overdosage”, and “Patient Counseling Information” sections of the labeling were updated in May 2022 to include information about the risk of drug-induced phospholipidosis leading to cardiotoxicity. Example: Plaquenil labeling |
Proton Pump Inhibitors
| Hypocalcemia and parathyroid hormone disorders |
Updated
The “Warnings and Precautions” section of the labeling was updated in November 2022 to include the risk of hypocalcemia and hypokalemia. Example: Protonix labeling |
| Sublocade (buprenorphine) | Injection site necrosis |
Updated
The “Dosage and Administration”, and “Warnings and Precautions” sections of the labeling were updated in March 2021 to include information about injection technique and risk of serious injection site reactions. |
| Tysabri (natalizumab) | Neonatal thrombocytopenia |
Updated
The “Dosage and Administration”, “Warnings and Precautions”, and “Use in Specific Populations” sections of the labeling were updated in December 2021 to include information about neonatal thrombocytopenia. FDA modified the Risk Evaluation and Mitigation Strategy (REMS) in December 2021 to align with labeling updates. |
Vinca alkaloids
| Incorrect route of product administration |
Updated
The “Warnings” and “Dosage and Administration” sections of the labeling were updated to recommend preparation only in intravenous infusion bags. An FDA Drug Safety Communication on vinca alkaloids was updated on April 21, 2022. |
| Xiidra (lifitegrast) | Hypersensitivity | FDA decided that no action is necessary at this time based on available information. |
| Xtandi (enzalutamide) | Severe cutaneous adverse reactions |
Updated
The “Adverse Reactions” section of the labeling was updated between October 2020 and May 2021 to include information about severe cutaneous adverse reactions. |
| Zolgensma (onasemnogene abeparvovec-xioi) | Thrombotic microangiopathy |
Updated
The “Warnings and Precautions”, and “Adverse Reactions” sections of the Product Information were updated in March 2021 to include information about the risk of thrombotic microangiopathy. |