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