Free Vioxx FAQs | Free Vioxx Legal FAQs

What Action Did The Fda Take?

Tue, 29 May 2007 21:19:00 GMT

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

Why Wasn't The Approve Trial Stopped Earlier?

Tue, 29 May 2007 21:19:00 GMT

The APPROVe trial began enrollment in 2000 and 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 that Vioxx carried any increased risk of cardiovascular events.

What Are Nsaids?

Tue, 29 May 2007 21:19:00 GMT

NSAIDs are a large group of drugs that have painrelieving (analgesic) and fever reducing (antipyretic) effects, as well as the effect of reducing inflammation when used over time. The antiinflammatory effects may take anywhere from a few days to three weeks to take effect. Nonselective (traditional) NSAIDs like Ibuprofen, aspirin, Nabumetone and Naproxen work by inhibiting both the COX1 and COX2 enzymes to stop the production of prostaglandins, while COX2 inhibitors only block the COX2 enzyme. Common uses for NSAIDs are:
Treatment of pain and inflammation associated with arthritis (inflammation and resulting pain of one or more joints, a common characteristic of over 200 rheumatic diseases with Osteoarthritis (OA) and Rheumatoid Arthritis (RA) being the most common forms).
Back pain and sciatica (pain down into the leg, which travels below the knee, and may involve the foot may occur alone or accompanied by low back pain).
Sprains, strains and rheumatism (a chronic autoimmune disease with inflammation of the joints and marked deformities).
Dental Pain
Postoperative pain
Menstrual cramps (primary dysmenorrhoea mild, and menorrhagia heavy).
Pain from kidney stones (renal colic).
Reduction of fevers
Migraines (recurrent severe headaches generally accompanied by an aura (classic migraine), nausea, vomiting, and dizziness).
Other painful conditions, particularly those with symptoms of inflammation.

NSAIDs come in different formulas and in overthecounter (OTC) and prescription strengths. Some may work better for you than others. Your physician can help you find the dose and medication that works best for you. Tell your physician if you are pregnant, have high blood pressure, asthma, or a history of kidney or liver disease, or have had ulcers in the past. People over age 65 must be especially careful when taking NSAIDs. Also tell your doctor about other medications you are taking. NSAIDs may intensify or counteract the effects of some medications. Both the risk and the severity of side effects increase the longer you take NSAIDs.

Can My Pharmacist Continue To Fill My Prescription For Vioxx?

Tue, 29 May 2007 21:19:00 GMT

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

I had a prescription for Vioxx, and now that Vioxx is off the market, what questions should I ask my doctor in choosing a different COX2 inhibitor?

There are four questions that should be considered when considering a COX2 inhibitor NSAID:

Is the COX2 inhibitor agent selective? (An agent must be more than 100fold more COX2 selective than COX1 to meet this criteria.)
Does the COX2 inhibitor agent have a sparing effect for stomach ulcers and other gastrointestinal bleeding and complications?
Does the COX2 inhibitor agent spare platelet function? (This is particularly important for those at risk for heat attacks, strokes or other cardiovascular condition caused by blood clots.)
Is the COX2 inhibitor agent effective clinically?

How can I report a serious Vioxx side effect to the FDA?

The FDA encourages anyone aware of a serious adverse reaction to make a MedWatch report. You can report an adverse event in two ways: Visit www.fda.gov/medwatch and click on "How to Report" Call (800) FDA1088

Where can I get more information on Vioxx?

You can obtain more information from Merck at: www.merck.com and www.vioxx.com, or (888) 36VIOXX (888) 3684699. To find out more about Vioxx from the FDA
Visit the FDA's Drug Information web page at: http://www.fda.gov/cder
Also, call Drug Information at (888) INFOFDA (888) 4636332.

Does The Withdrawal Of Vioxx From The Market Suggest That Other Drugs In The Same Class Are Dangerous?

Mon, 04 Jun 2007 21:51:22 GMT

The results of clinical studies with one drug in a given class do not necessarily apply to other drugs in the same class. Chronic use of NSAIDs has risks which include abdominal pain, nausea, indigestion, gastrointestinal (stomach) bleeding, as well as liver and kidney (renal) toxicity. However, COX2 inhibitors generally do not have as high a risk for gastrointestinal problems. Patients using these drugs for a long period of time (longer than two weeks) should be under the care of a doctor.

Were There Any Warning Flags That Led To Merck's Recall Of Vioxx?

Tue, 29 May 2007 21:19:00 GMT

When the FDA sent a warning letter to Merck in 1999 calling Merck's promotional materials "false and misleading," and when the FDA directed Merck to send a letter to healthcare professionals with warnings involving the safety of its medication in 2002, Vioxx was headed for trouble. It's no surprise Merck finally decided to pull the plug, and on September 30, 2004, Merck withdrew Vioxx from the shelves. The timeline below shows the warning flag that led to the Vioxx drug recall:

May 14, 1999. The Food and Drug Administration (FDA) approved the drug Vioxx manufactured by Merck, Inc., for relief of the signs and symptoms of osteoarthritis, the management of acute pain and the treatment of primary dysmenorrheal (menstrual cramping).

December, 1999. The FDA sent warning letters to Merck regarding misrepresentation of safety information in promotional material, calling the material "false and misleading."

November 23, 2000. An article in the New England Journal of Medicine reported the results of a randomized trial called the Vioxx Gastrointestinal Outcomes Research trial (VIGOR). The results of this trial, which was sponsored by Merck, revealed a 53 percent decrease in the risk of upper gastrointestinal toxicity, but a fivefold increase in the risk of myocardial infarction for Vioxx compared with Naproxen.

September 17, 2001. Merck received a letter from the FDA, warning the manufacturer from engaging in a promotional campaign for Vioxx that minimized the potentially serious cardiovascular findings that were observed in the VIGOR study.

April 1, 2002. Merck announced that it had won approval from the FDA to market Vioxx for the acute treatment of migraine with or without aura in adults.

April 11, 2002. The FDA approved a supplemental application for the use of Vioxx for the treatment of rheumatoid arthritis. It also approved a new label which added text regarding the new indication and precautions based on the results of the VIGOR trial.

April 11, 2002. Merck sent a "Dear Healthcare Professional" letter to physicians outlining the new label for Vioxx. The revised label recommended that physicians "use caution" in prescribing Vioxx for patients with ischemic heart disease and that 50 mg. a day is not recommended for chronic use. The April 2002 letter mentioned that the VIGOR study showed a higher incidence of serious cardiovascular thrombotic events including sudden death, myocardial infarction, unstable angina, transient ischemic attack (TIA) and peripheral venous and arterial thromboses. It also noted that in the phase III rheumatoid arthritis efficacy studies, the incidence of hypertension in rheumatoid arthritis patients receiving 25 mg. of Vioxx once daily was 10 percent, as compared to the incidence of hypertension in patients receiving 500 mg. of Naproxen twice daily at 4.7 percent.

September 9, 2004. Merck announced that Vioxx had received approval from the FDA for the treatment of juvenile rheumatoid arthritis (JRA) in children 2 years and older and who weigh at least 22 pounds.

September 27, 2004. The Data Safety Monitoring Board for an ongoing longterm study of Vioxx (APPROVe) recommended that the study be stopped for safety reasons. The study showed an increased risk of cardiovascular events (including heart attack and stroke) in patients on Vioxx compared to placebo, particularly those who had taken the drug for longer than 18 months.

September 28, 2004. Merck and FDA officials met. At that meeting the FDA was informed that Merck was voluntarily withdrawing Vioxx from the marketplace.

What Is Vioxx?

Tue, 29 May 2007 21:19:00 GMT

Vioxx (rofecoxib) is a prescription COX2 inhibitor nonsteroidal antiinflammatory drug (NSAID). Vioxx works by inhibiting the COX2 form of the COX enzyme to block production of prostaglandins. Prostaglandins are hormonelike substances that contribute to the symptoms of pain, fever and inflammation. Vioxx was used to treat arthritis, acute pain in adults, and painful menstrual cycles. Vioxx was approved by FDA in May 1999 for the relief of the signs and symptoms of osteoarthritis, for the management of acute pain in adults, and for the treatment of menstrual symptoms. Vioxx was later approved for the relief of the signs and symptoms of rheumatoid arthritis in adults and children. It comes as a tablet and a liquid that is usually taken once a day orally with or without food.

What Evidence Supports The Withdrawal?

Tue, 29 May 2007 21:19:00 GMT

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, a 156week (threeyear) trial, Vioxx was compared with placebo (sugar pill). The purpose of the trial was to see if the 25 mg dose of Vioxx was effective in preventing the recurrence of colon polyps. This trial was stopped early because there was an increased risk of serious cardiovascular events, such as heart attack and stroke, after 18 months of continuous treatment with Vioxx.

Why Has Vioxx Been Withdrawn From The Market?

Tue, 29 May 2007 21:19:00 GMT

New research shows that a major Vioxx side effect is a greatly increased risk of cardiovascular (CV) events such as heart attack or stroke if used longterm.

Did The Food And Drug Administration (Fda) Require The Removal Of Vioxx?

Tue, 29 May 2007 21:19:00 GMT

No. Merck made this decision independent of input from the FDA. The FDA agrees with the company that there appears to be significant safety concerns for patients, particularly those taking the drug longterm. The FDA plans to work closely with Merck to coordinate the withdrawal of this product from the U.S. market.

What Other Drugs Are Similar To Vioxx?

Tue, 29 May 2007 21:19:00 GMT

Vioxx is related to the nonselective (traditional) NSAIDs aspirin, Ibuprofen, Nabumetone, Naproxen, Ketoprofen and other traditional NSAIDs. Celebrex (celecoxib) and Bextra (valdecoxib) manufactured by Pfizer are other COX2 inhibitor NSAIDs that are similar to Vioxx. None of these similar drugs has been withdrawn. Consult with your physician to determine which is the right Vioxx alternative for you.

Why Wasn't The Approve Trial Stopped Earlier?

Tue, 29 May 2007 21:19:00 GMT

Does The Withdrawal Of Vioxx From The Market Suggest That Other Drugs In The Same Class Are Dangerous?

Mon, 04 Jun 2007 21:51:22 GMT

What Evidence Supports The Withdrawal?

Tue, 29 May 2007 21:19:00 GMT

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