Vioxx Attorney says: There are Many Valid Vioxx Concerns

The FDA approved Vioxx in 1999. It was intended to reduce the pain and inflammation caused by osteoarthritis as well as menstrual pains. Afterwards, the FDA approved Vioxx for the treatment of rheumatoid arthritis. The drug, which is a once-daily pill, was considered more effective than traditional pain killers and to cause fewer gastrointestinal side effects.

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.

Minor side effects with the use of Vioxx include upset stomach, dizziness, heartburn, vomiting and constipation. In March, 2002 an FDA report linked Vioxx to five cases of a nonbacterial type of meningitis. In May 2002, a report published in the Journal of Bone and Mineral Research stated that it may also impede bone repair due to the arthritis drug inhibiting cox-2 (which assists bone-forming cells in the healing process.)

The makers of Vioxx launched a three year study to confirm the relative gastrointestinal benefits of Vioxx when compared to another pain medicine, naproxen. The study did show that patients who took Vioxx had fewer ulcers and other stomach ailments, but the shock of the study proved to be the greater tendency to experience serious cardiovascular events when taking Vioxx.

In September 2004, Merck & Co., Inc., announced a voluntary withdrawal of Vioxx from the market due to safety concerns of an increased risk of cardiovascular problems such as heart attack, stroke, and blood clot. The study found that both high and low levels of the medication increase the risk, but patients taking the highest doses increase their risk of heart attack more than three-fold.

In Vioxx and naproxen test groups with more than 4,000 patients in each, Vioxx users suffered 101 “serious cardiovascular events” and 20 myocardial infarctions. That compared to 46 naproxen users who had cardiovascular events and only four who suffered heart attacks.

If you have concerns about the safety of Vioxx, or if you have experienced serious side effects associated with the drug, consult your doctor. It may also be important to contact an attorney who can help protect your legal rights. Please keep in mind that there may be time limits within which you must commence suit.

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Vioxx Attorney and Class Action Lawsuit Information on Heart Attack Drug Vioxx

Vioxx Class Action Drug Recall Lawsuit and Attorney Information.

Merck said that data from the trial showed the increased risk of heart attack and other cardiovascular complications began 18 months after patients started taking Vioxx. The data comes from a three-year study aimed at showing that Vioxx at a 25 milligram dose prevents recurrence of polyps in the colon and rectum. The trial was stopped after Merck discovered the higher heart risk compared to patients taking dummy pills.

FDA VIOXX STUDY

The FDA 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) today acknowledged the voluntary withdrawal from the market of Vioxx (chemical name rofecoxib), a non-steroidal anti-inflammatory drug (NSAID) manufactured by Merck & Co. FDA today 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.

Vioxx Attorney

A Vioxx attorney offers clients expertise in the side effects of this common arthritis pain medication. Vioxx attorneys are familiar with the very specific regulations that govern medical products liability; a Vioxx attorney can usually provide more accurate information than a regular attorney.

The advantage to retaining a Vioxx attorney is that the victim will be represented by an attorney who understands their problems. Experienced Vioxx attorneys understand the long-term implications of the side-effects for plaintiffs and their families, which means Vioxx attorneys are prepared to fight to ensure that their clients receive full and proper compensation. Many Vioxx attorneys are able to obtain large settlements from defendant corporations without having to go to trial. Vioxx attorneys can also help victims and their families form reasonable expectations and make sound decisions.

A Vioxx attorney has experience representing victims of Vioxx side effects, such as cardiac arrest. An experienced Vioxx attorney fully understands the implications of this serious problem, and the liability of manufacturers. Consulting a Vioxx attorney early on can help victims receive appropriate medical treatment and legal representation. An experienced Vioxx attorney is likely available in your area, and can discuss the merits of your case at no charge.