|
|
NEWS
RECALLS
COMPLAINT FORM
SCAM ALERTS
RESOURCES
Small Claims Guide Class Actions Lemon Laws FAQ Newsletters |
| Automotive Education Employment Electronics Family Finance Health Homeowners Pets Shopping Travel |
|
|
![]() |
Pfizer Finds Health Risk With Celebrex |
|||||
|
December 17, 2004
"These clinical trial results are new. The cardiovascular findings in one of the studies (APC) are unexpected and not consistent with the reported findings in the second study (PreSAP). Pfizer is taking immediate steps to fully understand the results and rapidly communicate new information to regulators, physicians and patients around the world," said Hank McKinnell, Pfizer chairman and chief executive officer. Celebrex is approved for use in the United States for the treatment of arthritis and pain, at recommended doses of 100mg to 200mg daily for osteoarthritis and 200mg to 400mg a day for rheumatoid arthritis. It is also approved for a rare condition called familial adenomatous polyposis in doses up to 800mg per day. The APC cancer trial studied Celebrex at doses of 400mg to 800mg per day. In the PreSAP cancer trial the dose was 400mg per day. "In placing this new information in context, it is important to understand that the APC trial results differ from both the PreSAP cardiovascular results as well as the large body of data that we and others have accumulated over time, in which an increased risk of serious cardiovascular events in arthritis patients, even at higher-than-recommended doses, had not been seen," said Dr. Joseph Feczko, president of worldwide development for Pfizer. A third long-term study involving Celebrex in patients at high-risk for Alzheimer's disease is also under way with about 2,000 patients enrolled, about 750 of whom are on 400mg per day of Celebrex. As with the cancer studies, this study is monitored by independent safety experts who meet regularly to assess adverse events. The company said a review by this board as recent as December 10 did not result in any recommendations to change the conduct of this study. Pfizer said it will continue to work with the FDA on the company's plans to sponsor a major clinical study to further assess Celebrex in osteoarthritis patients at high-risk for cardiovascular disease. Report Your Experience
|
|||||
Back to the top | |
||||||
|
|
Custom Search
|
||||
|
AUTOMOTIVE Dealers Manufacturers Service Extended Warranties Lemon Laws Recalls Tires Transporters FAMILY Aging Children, Parenting Recalls Dating Education Entertainment Pets Weddings |
FINANCE Annuities Banks Credit Cards Debt Collection Debt Counseling Insurance Investing Loans Mortgages Payday Loans Student Loans Tax Prep HEALTH Doctors Drugs, Pharmacies Health Clubs Hearing Care Hospitals Nursing Homes Nutrition, Diets Vision Care Weight Loss |
HOMEOWNERS & RENTERS Appliances Cookware Furniture Home Improvements Lawn & Garden Movers Pools & Spas Realtors, Rental Agents Recalls Utilities ELECTRONICS Cable TV/DBS Cameras Cell Phones Computers Home Electronics Internet Access Local Phone Service Long Distance VoIP |
SHOPPING In-Home Online Retail Stores Sporting Goods Supermarkets Telemarketers TRAVEL Airlines Bus Lines Car Rental Cruises Hotels Travel Agents Trains RESOURCES Class Actions Complaint Form Small Claims Guide Lemon Laws |
CONSUMER NEWS Latest News Automotive Telecom Financial Health Homeowners Scams Seniors Travel More ... RECALLS Automotive Children's Products Drugs Food Household Products Sporting Goods ABOUT US FAQ Privacy Policy Advertise With Us Newsroom Syndication Terms of Use |
Terms of Use Your use of this site constitutes acceptance of the Terms of Use
Copyright © 2003-2009 ConsumerAffairs.com Inc. All Rights Reserved. The contents of this site may not be republished, reprinted, rewritten or recirculated without written permission. |
|