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Merck Announces Voluntary Worldwide Withdrawal of VIOXX®
WHITEHOUSE STATION, N.J., Sept. 30, 2004—Merck & Co., Inc. today announced a voluntary worldwide withdrawal of VIOXX® (rofecoxib), its arthritis and acute pain medication.
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Vioxx Information
Vioxx Information
The company’s decision, which is effective immediately, is based on new, three-year data from a prospective, randomized, placebo-controlled clinical trial, the APPROVe (Adenomatous Polyp Prevention on VIOXX) trial. A study showed it caused increased risk of heart attack and stroke.
The trial, which is being stopped, was designed to evaluate the efficacy of VIOXX 25 mg in preventing recurrence of colorectal polyps in patients with a history of colorectal adenomas. In this study, there was an increased relative risk for confirmed cardiovascular events, such as heart attack and stroke, beginning after 18 months of treatment in the patients taking VIOXX compared to those taking placebo. The results for the first 18 months of the APPROVe study did not show any increased risk of confirmed cardiovascular events on VIOXX, and in this respect, are similar to the results of two placebo-controlled studies described in the current U.S. labeling for VIOXX.
“We are taking this action because we believe it best serves the interests of patients,” said Raymond V. Gilmartin, chairman, president and chief executive officer of Merck. “Although we believe it would have been possible to continue to market VIOXX with labeling that would incorporate these new data, given the availability of alternative therapies, and the questions raised by the data, we concluded that a voluntary withdrawal is the responsible course to take.”
VIOXX SIDE EFFECTS
Vioxx has been linked to increased risk of heart attack, stroke, sudden cardiac death and more. Side effects of Vioxx can include diarrhea, nausea and heartburn, but many patients may not associate these effects with the use of Vioxx. Merck has removed Vioxx after and and extended study showed that patients using Vioxx double their risk of having a heart attack, stroke or other cardiovascular injury
REFUND FOR UNUSED VIOXX® (rofecoxib)
If you are a patient who took VIOXX, you may be eligible to receive a refund for the amount you paid out-of-pocket for VIOXX that remained unused as of September 30, 2004. Merck strongly recommends that you return any unused VIOXX to the National Notification Center (NNC) in accordance with the instructions below. However, if you have already destroyed or disposed of your unused VIOXX, or cannot return it in its original container, you may still be eligible to receive a refund under new procedures adopted by Merck.
To receive a refund for the amount you paid out-of-pocket for VIOXX that remained unused as of September 30, 2004, please call the National Notification Center (NNC) at 1-800-805-9542
-- You must submit a valid pharmacy receipt indicating that the prescription was dispensed:
-- On or after August 1, 2004, for a 30-day supply of 12.5-mg or 25-mg VIOXX
-- On or after June 1, 2004, for any amount greater than a 30-day supply of 12.5-mg or 25-mg VIOXX On or after June 1, 2004, for any amount of 50-mg VIOXX
UPDATE
February 17, 2004 within hours of congressional passage of the bill limiting class action lawsuits that directly affects the drug companys, the makers of Vioxx announced it would bring Vioxx back onto the market.
VIOXX LAWSUIT
The first federal VIOXX lawsuit brought againts Merck, by Evelyn Plunkett of St. Augustine, Florida on behalf of her deceased husband Richard Irvin, ended in a deadlock jury on December 12, 2005, and a mistrial was declared. 6,500 lawsuits are still pending.
Merck won the second case in New Jersey Superior Court in Atlantic City on Nov. 3, 2005 against Frederick Humeston, who suffered a non-fatal heart attack in 2001. Humeston had been taking Vioxx for pain from knee injuries.
Merck lost in the Texas District Court in Angleton, near Houston, on Aug. 22, 2005. Plaintiff Carol Ernst sued Merck for the 2001 fatal heart attack of her husband, Robert Ernst. Ernst was awarded $253 million by the jury
