- Bactrim DS (sulfamethoxazole and trimethoprim)
- Septra (sulfamethoxazole and trimethoprim)
- Generic products containing sulfamethoxazole and trimethoprim
- Sulfatrim (sulfamethoxazole and trimethoprim)*
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.
- Nucala (mepolizumab)*
- Cinqair (reslizumab)*
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.
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
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
FDA decided that no action is necessary at this time based on available information.
The “Warnings and Precautions” section of the labeling was updated in December 2019 to include tumefactive multiple sclerosis.
The “Adverse Reactions” section of the labeling was updated in December 2019 to include thrombocytopenia.
- 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
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.
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.
- Livalo (pitavastatin)
- Zypitamag (pitavastatin magnesium )
The “Contraindications” and “Adverse Reactions” sections of the labeling were updated in October 2019 to include hypersensitivity reactions and angioedema.
The “Contraindications” and “Adverse Reactions” sections of the labeling were updated in February 2020 to include hypersensitivity reactions and angioedema.
The “Adverse Reactions” section of the labeling was updated in September 2019 to include angioedema.
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.
- Nipent (pentostatin)
- Generic products containing pentostatin
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.
- Onfi (clobazam)
- Generic products containing clobazam
The “Warnings and Precautions” section of the labeling was updated in March 2024 to include Drug rash with eosinophilia and systemic symptoms (DRESS).
The “Warnings and Precautions” and “Adverse Reactions” sections of the labeling were updated in June 2020 to include angioedema.
The “Warnings and Precautions” section of the labeling was updated in December 2019 to include anaphylaxis.
- Sensipar (cinacalcet hydrochloride)
- Generic products containing cinacalcet hydrochloride
The “Adverse Reactions” section of the labeling was updated in December 2019 to include chondrocalcinosis pyrophosphate (acute pseudogout).
Example: Sensipar labeling
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.
- Udenyca (pegfilgrastim-cbqv)
- Prolia (denosumab)
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.
FDA decided that no action is necessary at this time based on available information.
Vivitrol labeling
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.
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.
The “Adverse Reactions” section of the labeling was updated in June 2020 to include mucosal inflammation.
