Cardura (doxazosin)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
June 2016
USE IN SPECIFIC POPULATIONS
PLLR conversion. Please refer to the label for new information.
... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - June 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
Zosyn (piperacillin and tazobactam for injection) and Zosyn (piperacillin sodium and tazobactam sodium injection)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
June 2016
WARNINGS AND PRECAUTIONS
Severe Skin Reactions section renamed to Severe Cutaneous Adverse Reactions
Electrolyte... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - June 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Tyvaso (treprostinil)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
June 2016
WARNINGS AND PRECAUTIONS
Risk of Bleeding
(Add) Tyvaso inhibits platelet aggregation and increases the risk of... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - June 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Stivarga (regorafenib)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
June 2016
WARNINGS AND PRECAUTIONS
Hepatotoxicity
Severe drug-induced liver injury with fatal outcome occurred in... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - June 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Orfadin (nitisinone)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
June 2016
WARNINGS AND PRECAUTIONS
Change subsection heading of High Plasma Tyrosine Levels to Elevated Plasma Tyrosine Levels,... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - June 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Natpara (parathyroid hormone)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
June 2016
WARNINGS AND PRECAUTIONS
Hypercalcemia
In the pivotal trial, 3 patients randomized to NATPARA required administration... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - June 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Lybrel (levonorgestrel and ethinyl estradiol)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
June 2016
WARNINGS
Thromboembolic Disorders and Other Vascular Problems
Venous Thrombosis and Thromboembolism (addition of the... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - June 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Iclusig (ponatinib hydrochloride)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
June 2016
WARNINGS AND PRECAUTIONS
Increased Toxicity in Newly Diagnosed Chronic Phase CML
In a prospective randomized clinical... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - June 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Farydak (panobinostat)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
June 2016
WARNINGS AND PRECAUTIONS
Embryo-Fetal Toxicity
Change of time for females using effective contraception to at least 3... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - June 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Children's Motrin (ibuprofen)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
June 2016
WARNINGS
Do not use
If the child has ever had an allergic reaction to ibuprofen or any other pain reliever/fever... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - June 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Bendeka (bendamustine hydrochloride)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
June 2016
WARNINGS AND PRECAUTIONS
Infections
Addition of paragraph...Patients treated with bendamustine hydrochloride are at... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - June 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Afinitor (everolimus)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
June 2016
WARNINGS AND PRECAUTIONS
Non-infectious Pneumonitis
(Update of the following sentence in paragraph 1)... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - June 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Tybost (cobicistat)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
June 2016
CONTRAINDICATIONS
Table 2 Drugs that are Contraindicated with Concomitant use with Tybost and Atazanaivr or... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - June 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Technivie (ombitasvir, paritaprevir and ritonavir) Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
June 2016
CONTRAINDICATIONS
Table 2 (Drugs that are Contraindicated with TECHNIVIE)
Four drug classes added; please refer... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - June 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
