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

Is a Good Night's Sleep at the Top of Your Wishlist?

Ashwagandha Helps Hormones - Aids Arthritis

Why You Should Be Eating More Porcini Mushrooms

A Breathalyzer for Disease?

How Bacopa Can Help Improve Your Cognitive Function

Magnesium Reduces Diabetes and Helps Keep You Young

Lavender Aromatherapy Can Ease Pre-Op Anxiety

Give Your Health a Much-Needed Boost With Geranium

The Role of Resveratrol in Achieving Optimal Health

Could Coconut Oil Help Reduce Antibiotics?

 
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
Mitochondria Ignite™ with NT Factor® Ultra ATP+, Double Strength Vitamin D3 Extreme™


Article Comments



Be the first to comment on this article!

Post a Comment


 
Optimized Curcumin Longvida with Omega-3

Featured Products

Optimized Curcumin Longvida® Optimized Curcumin Longvida®
Supports Cognition, Memory & Overall Health
Energy NADH™ 12.5mg Energy NADH™ 12.5mg
Improve Energy & Cognitive Function
Ultra EPA  - Fish Oil Ultra EPA - Fish Oil
Ultra concentrated source of essential fish oils
FibroSleep™ FibroSleep™
The All-in-One Natural Sleep Aid
Vitamin D3 Extreme™ Vitamin D3 Extreme™
50,000 IU Vitamin D3 - Prescription Strength

Natural Remedies

Prepare Yourself for Cold & Flu Season Prepare Yourself for Cold & Flu Season
How I Found My Long-Lost Energy How I Found My Long-Lost Energy
The Crucial Role CoQ10 Plays in Fibromyalgia and ME/CFS The Crucial Role CoQ10 Plays in Fibromyalgia and ME/CFS
Undenatured Type II Collagen - Chicken Soup for Your Joints Undenatured Type II Collagen - Chicken Soup for Your Joints
Live Without Anxiety or Stress Live Without Anxiety or Stress

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