ProHealth health Vitamin and Natural Supplement Store and Health
Home  |  Log In  |  My Account  |  View Cart  View Your ProHealth Vitamin and Supplement Shopping Cart
800-366-6056  |  Contact Us  |  Help
Facebook Google Plus
Fibromyalgia  Chronic Fatigue Syndrome & M.E.  Lyme Disease  Natural Wellness  Supplement News  Forums  Our Story
Store     Brands   |   A-Z Index   |   Best Sellers   |   New Products   |   Deals & Specials   |   Under $10   |   SmartSavings Club

Trending News

16 Tips from 16 Years Sick

Fibromyalgia Fare Fit for All Seasons

Tangerine Oil: A Citrusy Essential Oil With Well-Rounded Uses

New Study Shows Artificial Sweeteners Lead to Diabetes

Essential Oils — An Effective and Healthy Option to Treat Headaches

Antioxidant treatment could halt neurodegeneration in early Parkinson's

Higher vitamin D levels associated with less severe disease in NAFLD patients

How zinc helps fight esophageal cancer

Krill Oil: Make This Omega-3 Supplement Part of Your Health Regimen

Everything You Need to Know About Black Cohosh

 
Print Page
Email Article

FDA MedWatch - COX-2 Selective and Non-Selective NSAIDs : Safety labeling changes

  [ 232 votes ]   [ Discuss This Article ]
www.ProHealth.com • June 15, 2005


MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA has requested that sponsors of all non-steroidal anti-inflammatory drugs (NSAID) make labeling changes to their products. FDA recommended proposed labeling for both the prescription and over-the-counter (OTC) NSAIDs and a medication guide for the entire class of prescription products.

All sponsors of marketed prescription NSAIDs, including Celebrex (celecoxib), a COX-2 selective NSAID, have been asked to revise the labeling (package insert) for their products to include a boxed warning, highlighting the potential for increased risk of cardiovascular (CV) events and the well described, serious, potential life-threatening gastrointestinal (GI) bleeding associated with their use.

FDA regulation 21CFR 208 requires a Medication Guide to be provided with each prescription that is dispensed for products that FDA determines pose a serious and significant public health concern. Read the complete MedWatch 2005 Safety summary, including a link to the updated Drug Information Page and Medication Guide, at: http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#NSAID



Post a Comment

Featured Products From the ProHealth Store
Vitamin D3 Extreme™ Energy NADH™ 12.5mg FibroSleep™


Article Comments



Be the first to comment on this article!

Post a Comment


 
Optimized Curcumin Longvida with Omega-3

Featured Products

Vitamin D3 Extreme™ Vitamin D3 Extreme™
50,000 IU Vitamin D3 - Prescription Strength
Ultra ATP+, Double Strength Ultra ATP+, Double Strength
Get energized with malic acid & magnesium
Optimized Curcumin Longvida® Optimized Curcumin Longvida®
Supports Cognition, Memory & Overall Health
Mitochondria Ignite™ with NT Factor® Mitochondria Ignite™ with NT Factor®
Reduce Fatigue up to 45%
FibroSleep™ FibroSleep™
The All-in-One Natural Sleep Aid

Natural Remedies

Can Autoimmune Conditions be Reversed? Researchers Make a Surprising Discovery Can Autoimmune Conditions be Reversed? Researchers Make a Surprising Discovery
Thyroid Health and Fibromyalgia Thyroid Health and Fibromyalgia
Breaking Through the Mental Fog Breaking Through the Mental Fog
Block Acid Reflux to Prevent Esophageal Problems! Block Acid Reflux to Prevent Esophageal Problems!
Vital Molecule Increases Cellular Energy and Improves Cognitive Function Vital Molecule Increases Cellular Energy and Improves Cognitive Function

CONTACT US
ProHealth, Inc.
555 Maple Ave
Carpinteria, CA 93013
(800) 366-6056  |  Email

· Become a Wholesaler
· Vendor Inquiries
· Affiliate Program
SHOP WITH CONFIDENCE
Credit Card Processing
SUBSCRIBE TO OUR NEWSLETTERS
Get the latest news about Fibromyalgia, M.E/Chronic Fatigue Syndrome, Lyme Disease and Natural Wellness

CONNECT WITH US ProHealth on Facebook  ProHealth on Twitter  ProHealth on Pinterest  ProHealth on Google Plus

© 2017 ProHealth, Inc. All rights reserved. Pain Tracker App  |  Store  |  Customer Service  |  Guarantee  |  Privacy  |  Contact Us  |  Library  |  RSS  |  Site Map