Overview
In May 1999, the FDA approved Vioxx (rofecoxib) for treatment of osteoarthritis, menstrual pain and for the management of acute pain in adults.

On Thursday, September 30, 2004, Merck announced a voluntary worldwide withdrawal of Vioxx after a study found that it doubled the risk of cardiovascular events including heart attack, stroke, and blood clots.

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.

What is VIOXX?
VIOXX is a prescription medicine called a COX-2 selective, nonsteroidal anti-inflammatory drug (NSAID).

What is VIOXX used for?
VIOXX is used in adults for:

• • relief of the pain and inflammation (swelling and soreness) of osteoarthritis (arthritis from wear and tear on your bones and your joints)
• relief of the pain and inflammation of rheumatoid arthritis in adults (arthritis caused by a condition
  where your immune system attacks your joints)
• management of short-term pain
• treatment of menstrual pain (pain during women’s monthly periods)
• treatment of migraine headache attacks with or without aura.

VIOXX is used in children and adolescents, of at least 2 years of age and who weigh at least 10 kg
(22 lbs.) to help relieve:

• the signs and symptoms of pauciarticular or polyarticular Juvenile Rheumatoid Arthritis (JRA). VIOXX has not been studied in children with systemic type JRA.

VIOXX has not been studied in children less than 2 years old or with body weight less than 10 kg (22 lbs.).