Zaltrap (ziv-aflibercept) Injection
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
June 2016
ADVERSE REACTIONS
Post Marketing Experience
(added) Cardiac disorders: Cardiac failure, Ejection fraction... (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
Zyban (Bupropion Hydrochloride)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
June 2016
ADVERSE REACTIONS
Postmarketing Experience
Nervous System
(recategorizing some adverse effects under a single... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - June 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Xyzal (levocetirizine dihydrochloride Oral Tabs)Xyzal (levocetirizine dihydrochloride Oral Solution)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
June 2016
ADVERSE REACTIONS
Post-Marketing Experience
Addition to listing of adverse reactions...arthralgia
... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - June 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Seroquel (quetiapine fumarate) and Seroquel XR (quetiapine fumarate)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
June 2016
ADVERSE REACTIONS
Post Marketing Experience
Adverse reactions reported since market introduction which were temporally... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - June 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Opsumit (macitentan)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
June 2016
ADVERSE REACTIONS
Postmarketing Experience
Cardiac disorders: symptomatic hypotension (addition)
... (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
DEPO-PROVERA (medroxyprogesterone acetate)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
June 2016
ADVERSE REACTIONS
General Disorders and Administration Site Condition: (addition to this section)
injection site... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - June 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Viekira PAK (ombitasvir, paritaprevir and ritonavir tablets; dasabuvir tablets)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
June 2016
DRUG INTERACTIONS
Established and Other Potential Drug Interactions
Table 5. Established Drug Interactions... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - June 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Tivicay (dolutegravir)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
June 2016
USE IN SPECIFIC POPULATIONS
Pediatric Patients
The safety, virologic, and immunologic responses in subjects who... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - June 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Pomalyst (pomalidomide)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
June 2016
ADVERSE REACTIONS
Postmarketing Experience (paragraph reformatted and bolded additions)
The following adverse... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - June 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Kuvan (sapropterin dihydrochloride)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
June 2016
ADVERSE REACTIONS
Clincial Trials Experiences
PKU Clinical Studies
In Study 7, 27 pediatric patients with PKU aged... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - June 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Envarsus XR (tacrolimus extended release)
p>Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
June 2016
USE IN SPECIFIC POPULATIONS
Race
(Addition of sentence) The pharmacokinetics of ENVARSUS XR were evaluated in a... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - June 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Dilantin (phenytoin) Injection, Dilantin (phenytoin) Oral Suspension
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
June 2016
PRECAUTIONS
General
Serum levels of phenytoin sustained above the optimal range may produce confusional states... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - June 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Cerebyx (fosphenytoin sodium)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
June 2016
PRECAUTIONS
General: (phenytoin associated)
Plasma concentrations of phenytoin sustained above the optimal range may... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - June 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
