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

Namzaric (memantine and donepezil hydrochlorides) Extended-release
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) July 2016 WARNINGS AND PRECAUTIONS Anesthesia Cardiovascular Conditions donepezil hydrochloride, (addition of an active... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts

Jardiance (empagliflozin)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) July 2016 WARNINGS AND PRECAUTIONS Ketoacidosis (addition of the following sentence) Fatal cases of ketoacidosis have been... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts

Humulin R U-500 (insulin human injection)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)  July 2016 WARNINGS AND PRECAUTIONS Hyperglycemia, Hypoglycemia or Death due to Dosing Errors with the Vial Presentation ... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts

Glyxambi (empagliflozin and linagliptin) & nbsp;
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) July 2016 WARNINGS AND PRECAUTIONS Ketoacidosis (addition of the following sentence in first paragraph) Fatal cases of... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts

Epivir (lamivudine) Tablets and Oral Solution
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) July 2016 WARNINGS AND PRECAUTIONS Lower Virologic Suppression Rates and Increased Risk of Viral Resistance with Oral Solution ... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts

Eliquis (apixaban)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) July 2016 WARNINGS AND PRECAUTIONS Bleeding Reversal of Anticoagulant Effect A specific antidote for ELIQUIS is not... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts

Aromasin (exemestane)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)  July 2016 WARNINGS AND PRECAUTIONS 2 subsections added: Use in Premenopausal Women AROMASIN is not indicated for the... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts

Acetadote (acetylcysteine) Injection
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) July 2016 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions replaces Anaphylactoid subheading (subsection revised) Serious... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts

Prismasol and Phoxillum Renal Replacement Solution
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) July 2016 CONTRAINDICATIONS PHOXILLUM and PRISMASOL replacement solutions are contraindicated in patients with known... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts

Mirvaso (brimonidine)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) July 2016 CONTRAINDICATIONS MIRVASO topical gel is contraindicated in patients who have experienced a hypersensitivity reaction to... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts

Lamprene (clofazimine)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) July 2016 PLR Conversion; refer to label. CONTRAINDICATIONS (addition) LAMPRENE is contraindicated in patients with known... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts

Isoniazid Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) July 2016 CONTRAINDICATIONS (updated) Isoniazid is contraindicated in patients who develop severe hypersensitivity reactions,... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts

Hicon (for the preparation of sodium iodide I 131 solution or sodium iodide I 131 capsules)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) July 2016 CONTRAINDICATIONS HICON is contraindicated in: Patients with vomiting and diarrhea Pregnancy Lactation ... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts

Evotaz (atazanavir/cobicistat)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)  July 2016 CONTRAINDICATIONS Table 1: Drugs that are Contraindicated with EVOTAZ Anticonvulsants Drug Class added to table... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts

Synjardy (empagliflozin and metformin hydrochloride)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) July 2016 BOX WARNING (revised as below) WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts

Noroxin (norfloxacin)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)   July 2016 BOX WARNING (revised) WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts

Moxifloxacin Injection
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) July 2016 BOX WARNING (revised)  WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts

Levaquin (levofloxacin)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)  July 2016 BOX WARNING (revised) WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts

Factive (gemifloxacin mesylate)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) July 2016 BOX WARNING (revised) WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY,... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts

Cipro (ciprofloxacin hydrochloride) Tablets, Solution, Oral SuspensionCipro XR (ciprofloxacin extended release) Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) July 2016 BOX WARNING (revised) WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY,... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts

Avelox (moxifloxacin hydrochloride)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) July 2016 BOX WARNING (revised) WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY,... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts

Cubicin (daptomycin for injection)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)   July 2016 ADVERSE REACTIONS Post-Marketing Experience Addition of the following adverse reactions: Blood and... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts

Caprelsa (vandetanib)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) July 2016 WARNINGS AND PRECAUTIONS Severe Skin Reactions (previously Skin Reactions and Stevens-Johnson Syndrome) Severe and... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts

Faslodex (fulvestrant)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) July 2016 WARNINGS AND PRECAUTIONS Injection Site Reaction (addition) Injection site related events including sciatica,... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts

Flovent Diskus (fluticasone propionate inhalation powder)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)   July 2016 ADVERSE REACTIONS Postmarketing Experience Infections and Infestations: Esophageal candidiasis. USE... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - July 1, 2016 Category: Drugs & Pharmacology Source Type: alerts

Seroquel (quetiapine fumarate) and Seroquel XR & nbsp;(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

Dilantin (phenytoin) Injection, & nbsp;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

Farydak (panobinostat) & nbsp;
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

Neupogen (filgrastim)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CBER) June 2016 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - June 1, 2016 Category: Drugs & Pharmacology Source Type: alerts

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