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

Relief for IBS, Colitis, Crohn’s And More

B Vitamins May Protect Against Damaging Effects of Air Pollution, and Improve Cognition and Psychiat...

Restless Leg Syndrome (RLS) - are you running a marathon each night?

Can Magnesium Relieve Your Tinnitus?

Resveratrol Proven to Slow Brain Aging

Magnesium Protects Against Stroke, Heart Disease and Diabetes

Fruits and vegetables' latest superpower? Lowering blood pressure

Neroli Oil: The Pleasantly Fragrant Citrus Oil

Prenatal vitamin D could help prevent autism in children

Restoring NAD+ could reduce DNA damage accumulation

 
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
FibroSleep™ Ultra ATP+, Double Strength Energy NADH™ 12.5mg

Looking for Vitamins, Herbs and Supplements?
Search the ProHealth Store for Hundreds of Natural Health Products


Article Comments



Be the first to comment on this article!

Post a Comment


 
NAD+ Ignite with Niagen

Featured Products

FibroSleep™ FibroSleep™
The All-in-One Natural Sleep Aid
Optimized Curcumin Longvida® Optimized Curcumin Longvida®
Supports Cognition, Memory & Overall Health
Ultra EPA  - Fish Oil Ultra EPA - Fish Oil
Ultra concentrated source of essential fish oils
Ultra ATP+, Double Strength Ultra ATP+, Double Strength
Get energized with malic acid & magnesium
Energy NADH™ 12.5mg Energy NADH™ 12.5mg
Improve Energy & Cognitive Function

Natural Remedies

Olea25 Olive Hydroxytyrosol Hits Astonishing 68,000+ ORAC Antioxidant Value Olea25 Olive Hydroxytyrosol Hits Astonishing 68,000+ ORAC Antioxidant Value
Astaxanthin - A Little-Known but Power-Packed Nutrient Astaxanthin - A Little-Known but Power-Packed Nutrient
The Curcumin Revolution: 'Golden' Ticket to Better Health The Curcumin Revolution: 'Golden' Ticket to Better Health
The Crucial Role CoQ10 Plays in Fibromyalgia and ME/CFS The Crucial Role CoQ10 Plays in Fibromyalgia and ME/CFS
Fight Inflammation and Promote Cognitive Health with High-OPC Grape Seed Fight Inflammation and Promote Cognitive Health with High-OPC Grape Seed

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