Pravachol (pravastatin sodium)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
July 2016
ADVERSE REACTIONS
Postmarketing Experience
Musculoskeletal: addition of tendon disorder, polymyositis
... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Mirapex ER (pramipexole) extended-release
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
July 2016
ADVERSE REACTIONS
Postmarketing Experience
Addition of the following paragraph:
There are postmarketing reports of... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Docetaxel Injection
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
July 2016
ADVERSE REACTIONS
Addition of:
Acute Myeloid Leukemia
Cutaneous Reactions
Neurologic Reactions
Eye... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Mirapex (pramipexole)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
July 2016
USE IN SPECIFIC POPULATIONS
PLLR Conversion:
Pregnancy
Risk Summary
There are no adequate data on the... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Kadcyla (ado-trastuzumab emtansine)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
July 2016
USE IN SPECIFIC POPULATIONS
Hepatic Impairment (revised)
No adjustment to the starting dose is required for patients... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Flovent HFA (fluticasone propionate)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
July 2016
USE IN SPECIFIC POPULATIONS
PLLR Conversion:
Pregnancy
Risk Summary
There are no randomized... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Effient (prasugrel)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
July 2016
USE IN SPECIFIC POPULATIONS
PLLR Conversion:
Pregnancy
Risk Summary
There are no data with Effient use... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Dulera (formoterol fumarate, mometasone furoate)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
July 2016
USE IN SPECIFIC POPULATIONS
PLLR Conversion:
Pregnancy
Risk Summary
There are no randomized clinical studies... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
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
Clinolipid (lipid injectable emulsion)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
July 2016
ADVERSE REACTIONS
Post-marketing Experience
Immune System Disorders: Hypersensitivity with the manifestations of rash... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Asmanex HFA (mometasone furoate)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
July 2016
USE IN SPECIFIC POPULATIONS
PLLR Conversion:
Pregnancy
Risk Summary
There are no randomized clinical studies... (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
Yondelis (trabectedin)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
July 2016
WARNINGS AND PRECAUTIONS
Hepatotoxicity
Assess LFTs prior to each administration of YONDELIS and as clinically... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Thallous Chloride T1201 Injection
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
July 2016
WARNINGS AND PRECAUTIONS
Risk of Extravasation and Tissue Damage (and Tissue Damage added)
Addition of: Confirm... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Dysport (abobotulinumtoxinA)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
July 2016
ADVERSE REACTIONS
The following serious adverse reactions are discussed below and elsewhere in labeling: (additions)
... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts