Consumer Guides

Government  Guides

Consumer News

Consumer Guide

Consumer Guides

Submit Government Guide

Submit Article
Consumer News Articles on
Products and Services

Copywriting Services


Auction Houses

Internet Auctions


Adoption Professionals

Adoption Record Access

Single Parent Adoption



Auto Directory

Auto Finance

Auto Insurance

Auto Leasing

Auto Auctions

Hybrids (HEV)


Human Genome Project



Business Transportation

Presidential Address:
Women's Small Business 

Jobs & Growth Act 2003

Investment Capital

Loan Request Documentation

Merchant Account Comparison

Cell Phones

Cell Phone Info



Data Centers

E-Commerce Tips

Computers & Energy Star

Computer Shopping Page

Wifi Wireless Fidelity

Free Wifi

Consumer News Articles

Consumer News Articles

Forklift Batteries

Clean Energy Systems

Cosmetic Surgery and Financing

CD Manufacturing Services

Organic Baby Furniture

LASIK Procedures and Costs


Hispanic Heritage Month

Customer Service

Digital Photography

Digital Photography Directory


National Disability Employment 
Awareness Month

New Freedom Initiative

FAQ's Disabilities and Work

Workforce Investment Act

Disaster Help

Guide to help
Rebuild Your Home


Guide to DVD's


Preparation, Survival





Accountants & Analysts

Administrative Service Managers

Budget Analysts

Construction Managers

Cost Estimators

Employment Interviewers

Engineering, Science, Computer
Systems Managers

Financial Managers

Job Training Initiative

Purchasers / Buyers


Graduate Degrees

Distance Learning

Types of Colleges

Educational Software

Original Educational
Initiative by
President Bill Clinton



Buying Clean Electricity

Energy Star


Hydrogen Fuel Cells



Wind Power

Zero Energy Buildings

Energy Star Technology

Energy Star Homes

Presidential Energy Address
April 2005

Computer Buyers Guide

Energy Star

Spectrally Selective
Low-E Glass


Women's Clothing


Accept Credit Cards

Actividades Bancarias


Capital Access
Grants, Loans

Check 21

Check 21 FAQ

Consumer Credit

Credit Cards

Currency & Coins

Currency: Buying, Selling

E-Commerce Associations

Electronic Banking

FDIC Insurance

Fair and Accurate Credit
Transaction Act of 2003

Forex Brokerages Directory:

Merchant Accounts

Merchant Account Services
Costs and Fees

Money & Credit Cards

Payment Processing

Stock Market Basics


Fishing Guide

Government Info

Government Grant Info

Global Warming Facts

Homeland Security

Preparing America

U.S. Immigration and Visas   


Hospital Comparison

FDA News Digest 
Dec. 03
Contaminated food warnings;
New Drug Treatments ... more

Health Insurance
Government Health Guides

Bird Flu News

What is Influenza? (Flu)


FDA on Vioxx

FDA Vioxx - Press Release

FDA Q & A Vioxx

Identity Theft

Consumer Confidential: 
The Privacy Story

New Law Signed
By President Bush


Information Bank


Life Insurance

Long Term Care

Jets: Private

Business Aircraft


Eclipse 500



Jewelry Guide

Precious Stones

Legal Guides

Legal Resources

Legal News



Farm, Food Processing


Medicare Premiums 2004

The Medicare Prescription 
Drug Improvement and 
Modernization Act of 2003

New Medicare Law - FAQ's

Patents & Trademarks

Patents, Trademarks, Copyrights

Press Releases
For Immediate Release


Political News

Barack Obama

Real Estate

100 Q & A's of
Home Buying

American Dream 
Downpayment Act 

Pardee Homes

Fair Housing Quiz

Financing Energy
Efficient Homes

Home Buying

Home Buying FAQ

Home Buying

Home Buying Loans

Home Mortgage

Manufactured Homes

Mortgage Refinance

Selling Your Home

Ten Tips For Home Buyers

Real Estate Directories

Sustainable Design:
Energy Efficient Homes

Free Soccer Posters

Specialty Directories

Offshore Directories

Real Estate Directories

Featured Directories


Tax Tips

Bush Tax Cut


Data Centers




Correct Time


Asbestos Issues


Sen. Bill Frist 

Sen. Hatch

Sen. Murray

Analysis - 
Asbestos Information Act of 1988
H.R. 5442



Tips For Women
Traveling Alone

U.S. Immigration and Visas

State Department Travel Tips

Other Online Guides







Vioxx (rofecoxib)
Source: FDA

Questions and Answers by 
Food & Drug Administration 
Date created: September 30, 2004


1.     What action did Merck take today? 

Merck announced a voluntary worldwide withdrawal of Vioxx (rofecoxib).

2.  What is Vioxx?

Vioxx is a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID).  Vioxx is also related to the nonselective NSAIDs , such as ibuprofen and naproxen. Vioxx is a prescription medicine used to relieve signs and symptoms of arthritis, acute pain in adults, and painful menstrual cycles.

3.  Did FDA require this action?

No, Merck made this decision independent of input from FDA.  The Agency has not had an opportunity to review the data from the study that was stopped in the depth that Merck has, but agrees with the company that there appear to be significant safety concerns for patients, particularly those taking the drug chronically.

FDA plans to work closely with Merck to coordinate the withdrawal of this product from the US market.

4.  What action did FDA take today?

FDA issued a public health advisory concerning the use of Vioxx. This advisory is based on Merck & Co., Inc. voluntarily withdrawing Vioxx from the market due to safety concerns.

5.  What should I do if I am currently taking Vioxx?

The risk that an individual patient will suffer a heart attack or stroke related to Vioxx is very small.  We encourage people taking Vioxx to contact their physician to discuss discontinuing use of Vioxx and alternative treatments.  Any decision about which drug product to take to treat your symptoms should be made in consultation with your physician based on an assessment of your specific treatment needs.

6.  What are the likely long-term health effects, if any, of taking this product?

The new study shows that Vioxx may cause an increased risk in cardiovascular events such as heart attack and strokes during chronic use.

7.  What evidence supports the Public Health Advisory?

Merck’s decision to withdraw Vioxx from the market is based on new data from a trial called the APPROVe [ Adenomatous Polyp Prevention on VIOXX] trial.  In the APPROVe trial, Vioxx was compared to placebo (sugar-pill).  The purpose of the trial was to see if Vioxx 25 mg was effective in preventing the recurrence of colon polyps.  This trial was stopped early because there was an increased risk for serious cardiovascular events, such as heart attacks and strokes, first observed after 18 months of continuous treatment with Vioxx compared with placebo.

8.  Why wasn’t the APPROVe trial stopped earlier?

The APPROVe trial began enrollment in 2000.  The trial was being monitored by an independent data safety monitoring board (DSMB). It was not stopped earlier because the results for the first 18 months of the trial did not show any increased risk of confirmed cardiovascular events on Vioxx.  

9.  What did FDA know about the risk of heart attack and stroke when it approved Vioxx?

FDA originally approved Vioxx in May 1999.  The original safety database included approximately 5000 patients on Vioxx and did not show an increased risk of heart attack or stroke.  A later study, VIGOR (VIOXX GI Outcomes Research), was primarily designed to look at the effects of Vioxx on side effects such as stomach ulcers and bleeding and was submitted to the FDA in June 2000.  The study showed that patients taking Vioxx had fewer stomach ulcers and bleeding than patients taking naproxen, another NSAID, however, the study also showed a greater number of heart attacks in patients taking Vioxx. The VIGOR study was discussed at a February 2001 Arthritis Advisory Committee and the new safety information from this study was added to the labeling for Vioxx in April 2002. Merck then began to conduct longer-term trials to obtain more data on the risk for heart attack and stroke with chronic use of Vioxx.

10.  Is FDA’s expedited review process putting riskier drugs on the market? 

No. Vioxx received a six-month priority review because the drug potentially provided a significant therapeutic advantage over existing approved drugs due to fewer gastrointestinal side effects, including bleeding.  A product undergoing a priority review is held to the same rigorous standards for safety, efficacy, and quality that FDA expects from all drugs submitted for approval. 

11. What other drugs are similar to Vioxx?

Vioxx is a COX-2 selective, nonsteroidal anti-inflammatory drug (NSAID).  Other COX-2 selective NSAIDs on the market at this time are Celebrex (celecoxib) and Bextra (valdecoxib). Vioxx is also related to the nonselective NSAIDs, such as ibuprofen and naproxen. You should consult your physician to determine which treatment is right for you.

12. Does today’s action suggest that other drugs in the same class are dangerous?

The results of clinical studies with one drug in a given class do not necessarily apply to other drugs in the same class.  All of the NSAIDs have risks when taken chronically, especially of gastrointestinal (stomach) bleeding, but also liver and kidney toxicity.  Patients using these drugs for a long period of time (longer than two weeks) should be under the care of a physician. 

13.  Will Vioxx be recalled?

FDA did not request a recall of Vioxx.  This product is being voluntarily withdrawn from the market by Merck.

14.  Can my pharmacist continue to fill my prescription for Vioxx?

No, Merck is initiating a market withdrawal in the United States to the pharmacy level. This means Vioxx will no longer be available at pharmacies.

15.  How can I report a serious side effect with Vioxx to FDA?

FDA encourages anyone aware of a serious adverse reaction to make a MedWatch report. You can report an adverse event in two ways:

16.  Where can I get more information?

You can obtain more information from Merck at:






There's a lot at stake...






© 2001-2008 Consumer-Guides.Info