Elitek (rasburicase)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
June 2016
BOX WARNING
Change 1st section of Anaphylaxis to read:
Hypersensitivity Reactions: Elitek can cause serious and fatal... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - June 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Sodium Bicarbonate Injection, USP by Hospira: Recall - Particulate Matter
Administration of product with particulates may result in localized inflammation, allergic reaction including anaphylaxis, granuloma formation, microembolic effects, or delay of therapy. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - March 21, 2016 Category: American Health Source Type: alerts
Invokamet (canagliflozin and metformin hydrochloride) Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
March 2016
CONTRAINDICATIONS
History of a serious hypersensitivity reaction to canagliflozin or metformin, such as anaphylaxis or... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - March 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Invokana (canagliflozin) Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
March 2016
CONTRAINDICATIONS
History of a serious hypersensitivity reaction to Invokana, such as anaphylaxis or angioedema.
... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - March 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Fanapt (iloperidone) Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
January 2016
CONTRAINDICATIONS
… Anaphylaxis, angioedema, and other hypersensitivity reactions have been reported
... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - January 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Xolair (omalizumab) Powder for Injection
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
December 2015
WARNINGS AND PRECAUTIONS
Anaphylaxis
A case-control study showed that, among Xolair users, patients with a history... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - December 1, 2015 Category: Drugs & Pharmacology Source Type: alerts
