Dexilant (dexlansoprazole delayed-release capsules)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
July 2016
ADVERSE REACTIONS
Clinical Trials Experience
Pediatrics (additional section added)
The safety of DEXILANT... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Alinia (nitazoxanide)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
July 2016
PLR Conversion; please refer to label.
ADVERSE REACTIONS (updated)
Clinical Trials Experience
Because clinical... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Avycaz (ceftazidime and avibactam)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
June 2016
ADVERSE REACTIONS
Clinical Trial Experience
(addition of new paragraph) AVYCAZ was evaluated in four active-controlled... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - June 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Elelyso (taliglucerase alfa)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
June 2016
ADVERSE REACTIONS
Immunogenicity
(updated paragraph) In a clinical trial of treatment-naïve pediatric patients, 2... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - June 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Humira (adalimumab)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
June 2016
WARNINGS AND PRECAUTIONS
Malignancies
Malignancies in Adults
39 global HUMIRA clinical trials replaces 37... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - June 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Canagliflozin (Invokana, Invokamet): Drug Safety Communication - Clinical Trial Results Find Increased Risk of Leg and Foot Amputations
FDA is currently investigating this new safety issue. Patients should not stop or change their diabetes medicines. (Source: FDA MedWatch Safety Alert)
Source: FDA MedWatch Safety Alert - May 18, 2016 Category: American Health Source Type: alerts
Nplate (romiplostim) for Injection, for Subcutaneous Use
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
April 2016
ADVERSE REACTIONS
Clinical Trials Experience
Bone Marrow Reticulin Formation and Collagen Fibrosis
Nplate... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - April 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Triumeq (abacavir, dolutegravir, and lamivudine) Tablets, For Oral Use
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
April 2016
ADVERSE REACTIONS
Clinical Trials Experience
Week 144 safety and efficacy data from Phase III study ING114467... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - April 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Xalkori (crizotinib) Capsules, for Oral Use
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
April 2016
ADVERSE REACTIONS
Clinical Trials Experience
Renal impairment
The estimated glomerular filtration... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - April 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Anoro Ellipta (umeclidinium and vilanterol inhalation powder), for Oral Inhalation
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
February 2016
ADVERSE REACTIONS
Postmarketing Experience
In addition to adverse reactions reported from clinical trials,... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - February 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Orenitram (treprostinil) Extended Release Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
January 2016
ADVERSE REACTIONS
Clinical Trials Experience
…The safety of Orenitram was also evaluated in an open-label... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - January 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Avastin (bevacizumab)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
December 2015
ADVERSE REACTIONS
Clinical Trial Experience
Renal Injury
A retrospective analysis across clinical... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - December 1, 2015 Category: Drugs & Pharmacology Source Type: alerts
Gilotrif (afatinib) Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
December 2015
ADVERSE REACTIONS
Clinical Trials Experience
nausea and vomiting, and adds a new subsection
... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - December 1, 2015 Category: Drugs & Pharmacology Source Type: alerts
Xeljanz (tofacitinib) Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
December 2015
WARNINGS AND PRECAUTIONS
Serious Infections
diverticulitis
ADVERSE REACTIONS
Clinical Trial... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - December 1, 2015 Category: Drugs & Pharmacology Source Type: alerts
Opdivo (nivolumab) Injection
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
November 2015
WARNINGS AND PRECAUTIONS
Immune-Mediated Pneumonitis
Across clinical trial experience with solid tumors... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - November 1, 2015 Category: Drugs & Pharmacology Source Type: alerts
