April - June 2019 | 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 August 5, 2024)
Bactrim DS (sulfamethoxazole and trimethoprim) Septra (sulfamethoxazole and trimethoprim) Generic products containing sulfamethoxazole and trimethoprim Updated Sulfatrim (sulfamethoxazole and trimethoprim)*	Hypersensitivity/Acute respiratory failure	Updated The “Warnings” section of the labeling was updated between November 2020 and October 2021 to include hypersensitivity reactions of the respiratory tract. Example: Bactrim DS labeling *An administrative error resulted in the omission of Sulfatrim from this signal and was added after the initial quarterly report was posted.
Fasenra (benralizumab) Updated Nucala (mepolizumab)* Cinqair (reslizumab)*	Flu-like illness	Updated FDA decided that no action is necessary at this time based on available information.  *An administrative error resulted in the omission of Nucala and Cinqair from this signal and was added after the initial quarterly report was posted.
Fasenra (benralizumab) Updated Cinqair (reslizumab)*	Herpes zoster	Updated FDA decided that no action is necessary at this time based on available information.  *An administrative error resulted in the omission of Cinqair from this signal and was added after the initial quarterly report was posted.
Feraheme (ferumoxytol) Ferrlecit (sodium ferric gluconate) INFeD (iron dextran) Injectafer (ferric carboxymaltose) Venofer (iron sucrose) Generic products containing sodium ferric gluconate	Fetal death	Updated The “Use in Specific Populations (Pregnancy)” section of the labeling was updated in March 2020 for Ferrlecit and September 2020 for Feraheme, INFeD, Injectafer, and Venofer to include risks to the fetus associated with maternal severe hypersensitivity reactions. Example: Feraheme labeling
Gamunex-C [Immune Globulin (Human), 10% Caprylate/Chromatography Purified]	Increased hypersensitivity reactions in patients receiving certain product lots	Updated FDA decided that no action is necessary at this time based on available information.
Gilenya (fingolimod)	Tumefactive multiple sclerosis	Updated The “Warnings and Precautions” section of the labeling was updated in December 2019 to include tumefactive multiple sclerosis. Gilenya labeling
Gilenya (fingolimod)	Thrombocytopenia	Updated The “Adverse Reactions” section of the labeling was updated in December 2019 to include thrombocytopenia. Gilenya labeling
HMG-CoA reductase inhibitors Altoprev (lovastatin) Caduet (amlodipine besylate and atorvastatin calcium) Crestor (rosuvastatin calcium) Ezallor (rosuvastatin) Lescol (fluvastatin sodium) Lescol XL (fluvastatin sodium) Liptruzet (atorvastatin and ezetimibe) Livalo (pitavastatin) Pitavastatin Pravachol (pravastatin sodium) Zocor (simvastatin) Zypitamag (pitavastatin magnesium ) Generic products containing HMG-CoA reductase inhibitors	Immune-mediated necrotizing myopathy	Updated The “Warnings and Precautions” section of the labeling was updated in September 2020 to include immune-mediated necrotizing myopathy. Example: Crestor labeling The FDA withdrew approval for Lescol in the Federal Register effective May 1, 2019. Withdrawal of Approval for Lescol The FDA withdrew approval for Pravachol in the Federal Register effective October 5, 2023. Withdrawal of Approval for Pravacol
Increlex (mecasermin)	Malignancies	Updated The “Contraindications”, “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information and Patient Information” sections of the labeling were updated in December 2019 to include nonmalignant and malignant neoplasia. Increlex labeling
Livalo (pitavastatin) Zypitamag (pitavastatin  magnesium )	Drug hypersensitivity	Updated The “Contraindications” and “Adverse Reactions” sections of the labeling were updated in October 2019 to include hypersensitivity reactions and angioedema. Livalo labeling The “Contraindications” and “Adverse Reactions” sections of the labeling were updated in February 2020 to include hypersensitivity reactions and angioedema. Zypitamag labeling
Mavyret (glecaprevir and pibrentasvir)	Hypersensitivity: angioedema and anaphylaxis	Updated The “Adverse Reactions” section of the labeling was updated in September 2019 to include angioedema. Mavyret labeling
Ninlaro (ixazomib)	Thrombotic microangiopathy (TMA)	Updated The “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information”, and “Patient Package Insert” sections of the labeling were updated in February 2020 to include thrombotic microangiopathy. Ninlaro labeling
Nipent (pentostatin) Generic products containing pentostatin	Thrombotic microangiopathy (TMA)	Updated The “Adverse Reactions” section of the labeling was updated in October 2019 to include febrile neutropenia, hemolytic uremic syndrome, thrombotic thrombocytopenic purpura, and autoimmune thrombocytopenia. Nipent labeling
Onfi (clobazam) Generic products containing clobazam	Drug rash with eosinophilia and systemic symptoms (DRESS)	Updated The “Warnings and Precautions” section of the labeling was updated in March 2024 to include Drug rash with eosinophilia and systemic symptoms (DRESS). Onfi labeling
Orencia (abatacept)	Angioedema	Updated The “Warnings and Precautions” and “Adverse Reactions” sections of the labeling were updated in June 2020 to include angioedema. Orencia labeling
Orbactiv (oritavancin diphosphate)	Anaphylaxis	Updated The “Warnings and Precautions” section of the labeling was updated in December 2019 to include anaphylaxis. Orbactiv labeling
Sensipar (cinacalcet hydrochloride) Generic products containing cinacalcet hydrochloride	Chondrocalcinosis pyrophosphate	Updated The “Adverse Reactions” section of the labeling was updated in December 2019 to include chondrocalcinosis pyrophosphate (acute pseudogout). Example: Sensipar labeling
Tecfidera (dimethyl fumarate)	Serious herpes infection	Updated The “Warnings and Precautions”, “Adverse reactions”, and “Patient Counseling Information” sections of the labeling were updated in December 2019 to include the risk for serious herpes zoster and other serious opportunistic infections. Tecfidera labeling
Udenyca (pegfilgrastim-cbqv) Prolia (denosumab)	Medication error – Labeling confusion (wrong drug errors)	Updated The carton labeling and tray labels for Udenyca were revised in October 2019 to mitigate the risk of product selection errors between Udenyca and Prolia.
Velphoro (sucroferric oxyhydroxide)	Hemoglobin increased	Updated FDA decided that no action is necessary at this time based on available information.
Vivitrol (naltrexone hydrochloride)	Medication Error - Patient self-administration errors	The carton labeling, sections of the product labeling (“Dosage and Administration”, “Warnings and Precautions,” “Adverse Reactions,” “How Supplied/Storage and Handling,” and “Patient Counseling”), and the Medication Guide, were updated to emphasize that Vivitrol must be injected by a healthcare provider. Vivitrol labeling
Xofluza (baloxavir marboxil)	Anaphylaxis and angioedema	Updated The “Contraindications”, “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling were updated in October 2019 to include anaphylaxis, angioedema, urticaria, and erythema multiforme. Xofluza labeling
Xofluza (baloxavir marboxil)	Medication error - Labeling confusion (wrong dose errors)	Updated The “Dosage and Administration”, “How Supplied/Storage and Handling”, and “Patient Counseling Information” sections of the labeling, the carton labeling, and container labels were updated in October 2019 to address dosing errors.  Xofluza labeling
Yondelis (trabectedin)	Interstitial lung disease and mucositis	Updated The “Adverse Reactions” section of the labeling was updated in June 2020 to include mucosal inflammation. Yondelis labeling