header

Merck Vioxx is a Cox-2 Inhibitor, and was prescribed for the treatment of osteoarthritis, menstrual cramps, and adult pain management. The drug became so popular and widely used that Merck, the manufacturer of the drug Vioxx, is reported to have made an impressive $8 billion profit over the span of five years. However, on September 30th 2004, following indications from trials and tests, Merck Vioxx was pulled from the US market.

Recent result from trials and studies have shown that Merck Vioxx, approved in 1999 by the FDA and prescribed to millions, results in an increased risk of heart attacks and strokes in patients. Merck has recalled Vioxx voluntarily following these results. However, there have also been a number of reports that Merck may have known about the dangers of Vioxx several years ago but failed to take action and recall it at that time. Merck's Vioxx recall has spawned a number of allegations with regards to how long the manufacturer has known about these side effects.

Merck officials have disputed these allegations, stating that the only conclusive evidence was presented recently, after which they have recalled the drug from the market. However, it is likely that, whatever the circumstances, this situation is going to result in a large number of lawsuits against Merck from Vioxx patients that have suffered ill effects and damages from taking the drug.

Vioxx is a non-steroid anti-inflammatory drug (NSAID) that was hailed a miracle drug in May 1999 when it was approved by the FDA (Food and Drugs Administration) for the treatment of osteoarthritis, menstrual cramps, and adult pain management. The reason for the enthusiasm shown by the medical world when this drug was approved was due to the keys difference between the drug and the previously used NSAIDs. Voixx, along with Celebrex, was one of a new breed of NSAIDs known as Cox-2 Inhibitors. This is because the drug selectively inhibited only the Cox-2 enzyme produced by the body, whereas other NSAIDs also prohibited the Cox-1 enzyme, which was responsible for protecting the stomach lining and therefore often resulted in severe gastric problems.

However, following studies performed recently, it has been discovered that Vioxx is associated with a far more worrying side effect than stomach problems. This drug has been linked to dramatically increased cases of stroke and heart disease, and on September 30, 2004 was withdrawn from the market by its manufacturing company, Merck.

The FDA has posted the results of a study into Merck Vioxx, and have stated that, compared to Celebrex - another Cox-2 Inhibitor approved in 1999 - Merck's vioxx increased the risk of "serious coronary heart disease" by 3-7 times.

Merck & Co., Inc. announced a voluntary withdrawal of Vioxx from the U.S. market due to safety concerns. Vioxx is a prescription COX-2 selective, non-steroidal anti-inflammatory drug (NSAID) that 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. It is also approved for the relief of the signs and symptoms of rheumatoid arthritis in adults and children.

The Agency was informed by Merck & Co., Inc. on September 27, 2004, that the Data Safety Monitoring Board for an ongoing long-term study of Vioxx (APPROVe) had recommended that the study be stopped early for safety reasons. The study was being conducted in patients at risk for developing recurrent colon polyps. 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 been taking the drug for longer than 18 months. Based on this new safety information, Merck and FDA officials met the next day, September 28, 2004, and during that meeting FDA was informed that Merck was voluntarily withdrawing Vioxx from the market place.

The risk that an individual patient taking Vioxx will suffer a heart attack or stroke related to the drug is very small. Patients who are currently taking Vioxx should contact their physician for guidance regarding discontinuation and alternative therapies.

The Food and Drug Administration (FDA) acknowledged the voluntary withdrawal from the market of Vioxx (chemical name rofecoxib), a non-steroidal anti-inflammatory drug (NSAID) manufactured by Merck & Co. FDA also issued a Public Health Advisory to inform patients of this action and to advise them to consult with a physician about alternative medications.

Merck is withdrawing Vioxx from the market after the data safety monitoring board overseeing a long-term study of the drug recommended that the study be halted because of an increased risk of serious cardiovascular events, including heart attacks and strokes, among study patients taking Vioxx compared to patients receiving placebo. The study was being done in patients at risk of developing recurrent colon polyps.

"Merck did the right thing by promptly reporting these findings to FDA and voluntarily withdrawing the product from the market," said Acting FDA Commissioner Dr. Lester M. Crawford. "Although the risk that an individual patient would have a heart attack or stroke related to Vioxx is very small, the study that was halted suggests that, overall, patients taking the drug chronically face twice the risk of a heart attack compared to patients receiving a placebo."

Dr. Crawford added that FDA will closely monitor other drugs in this class for similar side effects. "All of the NSAID drugs have risks when taken chronically, especially of gastrointestinal bleeding, but also liver and kidney toxicity. They should only be used continuously under the supervision of a physician."

FDA approved Vioxx in 1999 for the reduction of pain and inflammation caused by osteoarthritis, as well as for acute pain in adults and for the treatment of menstrual pain. It was the second of a new kind of NSAID (Cox-2 selective) approved by FDA. Subsequently, FDA approved Vioxx to treat the signs and symptoms of rheumatoid arthritis in adults and children.

At the time that Vioxx and other Cox-2 selective NSAIDs were approved, it was hoped that they would have a lower risk of gastrointestinal ulcers and bleeding than other NSAIDs (such as ibuprofen and naproxen). Vioxx is the only NSAID demonstrated to have a lower rate of these side effects.

Merck contacted FDA on September 27, 2004, to request a meeting and to advise the agency that the long-term study of Vioxx in patients at increased risk of colon polyps had been halted. Merck and FDA officials met the next day, September 28, and during that meeting the company informed FDA of its decision to remove Vioxx from the market voluntarily.

In June 2000, Merck submitted to FDA a safety study called VIGOR (Vioxx Gastrointestinal Outcomes Research) that found an increased risk of serious cardiovascular events, including heart attacks and strokes, in patients taking Vioxx compared to patients taking naproxen. After reviewing the results of the VIGOR study and other available data from controlled clinical trials, FDA consulted with its Arthritis Advisory Committee in February 2001 regarding the clinical interpretation of this new safety information. In April 2002, FDA implemented labeling changes to reflect the findings from the VIGOR study. The labeling changes included information about the increase in risk of cardiovascular events, including heart attack and stroke.

Recently other studies in patients taking Vioxx have also suggested an increased risk of cardiovascular events. FDA was in the process of carefully reviewing these results, to determine whether further labeling changes were warranted, when Merck informed the agency of the results of the new trial and its decision to withdraw Vioxx from the market.

Various journals, such as The Lancet and The Wall Street Journal have published information indicating that Merck knew about these increased risks years ago, yet continued to market the drug. If this is the case, Merck will be liable to pay compensation to those affected by Vioxx, in order to enable victim to recoup medical costs, loss of income and pain or suffering.

As someone that has been affected by this drug, you will have the option of filing a compensation claim against the manufacturer, Merck. You can do this in a couple of ways: you could either file an individual lawsuit against Merck for compensation; or you could file as part of a class action suit along with other victims that have suffered as a result of taking this drug. Unless you are experienced in legal matters of this sort, it can be difficult to know which of these legal options will best suit you. It is therefore strongly advised that you contact an experienced lawyer to discuss your case further.