• Bactrim DS (sulfamethoxazole and trimethoprim)
• Septra (sulfamethoxazole and trimethoprim)
• Generic products containing sulfamethoxazole and trimethoprim

• Sulfatrim (sulfamethoxazole and trimethoprim)*

Hypersensitivity/Acute respiratory failure 

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)   Flu-like illness FDA is evaluating the need for regulatory action. Fasenra (benralizumab) Herpes zoster FDA is evaluating the need for regulatory action.

• Feraheme (ferumoxytol)
• Ferrlecit (sodium ferric gluconate)
• INFeD (iron dextran)
• Injectafer (ferric carboxymaltose)
• Venofer (iron sucrose)
• Generic products containing sodium ferric gluconate

Fetal death FDA is evaluating the need for regulatory action. Gamunex-C [Immune Globulin (Human), 10% Caprylate/Chromatography Purified] Increased hypersensitivity reactions in patients receiving certain product lots FDA is evaluating the need for regulatory action Tumefactive multiple sclerosis FDA is evaluating the need for regulatory action. Thrombocytopenia FDA is evaluating the need for regulatory action. 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 necrotising myopathy FDA is evaluating the need for regulatory action. Increlex (mecasermin) Malignancies FDA is evaluating the need for regulatory action.

• Livalo (pitavastatin)
• Zypitamag (pitavastatin  magnesium )

Drug hypersensitivity FDA is evaluating the need for regulatory action. Mavyret (glecaprevir and pibrentasvir) Hypersensitivity: angioedema and anaphylaxis FDA is evaluating the need for regulatory action Ninlaro (ixazomib)   Thrombotic microangiopathy (TMA) FDA is evaluating the need for regulatory action.

• Nipent (pentostatin)
• Generic products containing pentostatin

Thrombotic microangiopathy (TMA) FDA is evaluating the need for regulatory action.

• Onfi (clobazam)
• Generic products containing clobazam

Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) FDA is evaluating the need for regulatory action. Orencia (abatacept) Angioedema FDA is evaluating the need for regulatory action. Orbactiv (oritavancin diphosphate) Anaphylaxis FDA is evaluating the need for regulatory action.

• Sensipar (cinacalcet hydrochloride)
• Generic products containing cinacalcet hydrochloride

Chondrocalcinosis pyrophosphate FDA is evaluating the need for regulatory action. Tecfidera (dimethyl fumarate) Serious herpes infection FDA is evaluating the need for regulatory action.

• Udenyca (pegfilgrastim-cbqv)
• Prolia (denosumab)

Medication error – Labeling confusion (wrong drug errors) FDA is evaluating the need for regulatory action. Velphoro (sucroferric oxyhydroxide) Hemoglobin increased FDA is evaluating the need for regulatory action. 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 FDA is evaluating the need for regulatory action. Xofluza (baloxavir marboxil) Medication error - Labeling confusion (wrong dose errors) FDA is evaluating the need for regulatory action Yondelis (trabectedin) Interstitial lung disease and mucositis FDA is evaluating the need for regulatory action

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