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 Magnesium the Missing Link in Your Heart Healthy Routine?

A Little Zinc Goes a Long Way

Supplementation with vitamin D associated with improved testosterone, erectile function among middle...

More evidence for calorie restriction’s longevity effect

Vitamin D deficiency increases risk of chronic headache

Wearable biosensors can flag illness, Lyme disease, risk for diabetes; low airplane oxygen

VIDEO: The Best Brain Foods That Help Increase Your Memory!

Iron (And More) For Lasting, Natural Energy

Affordable Care Act made cancer screening more accessible for millions, study finds

Metabolic syndrome increases the need for vitamin E

 
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
Energy NADH™ 12.5mg Vitamin D3 Extreme™ Ultra ATP+, Double Strength

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

Mitochondria Ignite™ with NT Factor® Mitochondria Ignite™ with NT Factor®
Reduce Fatigue up to 45%
Optimized Curcumin Longvida® Optimized Curcumin Longvida®
Supports Cognition, Memory & Overall Health
FibroSleep™ FibroSleep™
The All-in-One Natural Sleep Aid
Ultra EPA  - Fish Oil Ultra EPA - Fish Oil
Ultra concentrated source of essential fish oils
Energy NADH™ 12.5mg Energy NADH™ 12.5mg
Improve Energy & Cognitive Function

Natural Remedies

Coenzyme Q10 - The Energy Maker Coenzyme Q10 - The Energy Maker
Astaxanthin - A Little-Known but Power-Packed Nutrient Astaxanthin - A Little-Known but Power-Packed Nutrient
When a Negative is Positive - Goodnighties Recovery Sleepwear When a Negative is Positive - Goodnighties Recovery Sleepwear
Front Line Defense Against Colds & Flu - Support for Healthy Immune System Balance Front Line Defense Against Colds & Flu - Support for Healthy Immune System Balance
Everything You Always Wanted to Know About Sleep But Were Too Tired to Ask Everything You Always Wanted to Know About Sleep But Were Too Tired to Ask

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