Vioxx - Important Safety Information

General Information About Making a Vioxx Claim:

Update - September 30, 2004:

FDA Issues Public Health Advisory on Vioxx as its Manufacturer Voluntarily Withdraws the Product

"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..."

Vioxx Drug
The Vioxx drug (generic name: Rofecoxib) was designed to help patients who have been diagnosed with arthritis. Vioxx is classified as COX-2 inhibitors, which became available in the late 1990s. Originally, Vioxx drug reports seemed promising, since the potential for gastrointestinal side effects were lower than anti-inflammatory drugs. Vioxx drug was heavily marketed as a “miracle drug” to treat arthritis pain, but recent research indicates Vioxx drug patients may experience serious, even life threatening side effects while seeking pain relief.

Vioxx is used as a treatment for signs and symptoms of osteoarthritis, acute pain in adults, and painful menstrual cycles. Serious problems from stomach ulcers, such as bleeding, are well known complications in people treated with NSAIDs. Similar problems have occurred in people treated with Vioxx. Other adverse reactions can include liver damage. Some of the warning signs of liver damage can be nausea, vomiting, fatigue, loss of appetite, itching, yellow coloring of skin or eyes, "flu like" symptoms and dark urine.

Vioxx Side Effects
Vioxx side effects include diarrhea, nausea, and heartburn, but many patients may be unaware that the risk for Vioxx side effects such as heart attacks are nearly four times greater than those of traditional pain relievers. Vioxx side effects, including heart attacks, were discussed in a report recently released by the Cleveland Clinic. The Vioxx side effects were compared to those of patients treated with standard nonsteroidal anti-inflammatory drugs (NSAIDs), with Vioxx side effects relating to heart attacks appearing far more commonly in users of Vioxx.

Vioxx drug studies now show higher risk for heart problems and the same risk for kidney problems in Vioxx drug patients as in those taking aspirin or ibuprofen. Doctors have also linked the use of Vioxx drugs to 12 cases of nonbacterial meningitis (inflammation of the membrane covering the brain). Although Vioxx drug research almost always pertains specifically to patients who have used the Vioxx drug, experts believe that the same risks are associated with other COX-2 inhibitors, including Celebrex.

Vioxx drug use can lead to severe stomach complications, especially in patients who had ulcers before using Vioxx drugs. Individuals who have had asthma, hives, or other allergic reactions to aspirin should not take Vioxx drugs without first consulting a physician. Other persons considered at higher risk for Vioxx drug side effects include persons with severe kidney or liver problems, and pregnant women.

Common Vioxx drug side effects include upper respiratory tract infection, diarrhea, nausea, heartburn and high blood pressure. Vioxx drugs have had FDA approval since May of 1999. Doctors and former users of Vioxx drugs are reporting information to the FDA that indicates the severe risks associated with Vioxx drugs.

The Vioxx Gastrointestinal Outcomes Research (VIGOR) conducted a prospective randomized double blind one year study evaluating approximately 4000 patients on Vioxx 50 mg a day and approximately 4000 patients on the standard dose of naproxen (1000 mg a day), a non steroidal anti inflammatory drug (NSAID). The study found that there was a higher cumulative rate of serious cardiovascular thromboembolic adverse events (such as heart attacks, angina pectoris and peripheral vascular events) in the Vioxx group (1.8%) compared to the naproxen group (0.6%). Adjudicated serious cardiovascular events (confirmed by a blinded adjudication committee) included: sudden death; myocardial infarction; unstable angina; ischemic stroke; transient ischemic attack; peripheral venous; and arterial thromboses.

After carefully reviewing the results of the VIGOR Study, the FDA agreed with the Arthritis Advisory Committee recommendations of February 8, 2001 that the label for Vioxx should include the gastrointestinal and cardiovascular information. The committee advised that the NSAID class warning regarding gastrointestinal adverse events should be modified, but not removed from the Vioxx label. This warning advises patients and their doctors about the risks of gastrointestinal ulcers, bleeding and perforation.
The potential Vioxx side effects, especially those relating to heart trouble, may be related to the attempt to avoid any Vioxx side effects having to do with gastrointestinal problems. NSAIDs inhibit both Cox-1 and Cox-2 enzymes—while Vioxx side effects relating to stomach problems are lower, because VIOXX is only a Cox-2 inhibitor. Potential Vioxx side effects like ulcers are lower, because VIOXX does not affect Cox-1 enzymes that protect the stomach. Vioxx side effects relating to heart problems may result from the inhibiting Cox-2 enzymes, which may prevent clotting.

Vioxx Information
Vioxx information from recent clinical trials indicates that users have an increased risk of cardiac problems. The Vioxx information relating to potential side effects was not fully understood when Vioxx received FDA approval; Vioxx information on common side effects (such as upset stomach) was available, but there was no Vioxx information indicating the serious potential problems such as cardiac arrest or stroke. At the time of approval, Vioxx information indicated that the drug had lower risks for causing gastrointestinal bleeding; based on this Vioxx information, the drug was widely hailed as a breakthrough for arthritis sufferers.

Researchers have since released Vioxx information indicating the chances for heart attack was four times greater than with older arthritis pain relievers. Vioxx information also links the drug to angina pectoris, stroke, and clotting. In addition, some startling Vioxx information was reported in 2002, when an FDA report linked several instances of nonbacterial meningitis with Vioxx, information that could prove the life-threatening potential of the drug.

Vioxx Lawsuit
A Vioxx lawsuit stems from reports of side effects including blood clots, heart attacks, and stroke. A Vioxx lawsuit attempts to recover funds related to damages suffered due to the use of Vioxx. Vioxx lawsuits fall under a category known as “products liability”, claiming that the manufacturers of Vioxx (Vioxx lawsuit defendants) or their distributors, knew that the drug could cause harm. In a Vioxx lawsuit, as in any products liability suit, there must be proof that the defendants named in the Vioxx lawsuit failed to properly provide for the safety of the plaintiff, and that the person filing the Vioxx lawsuit was harmed as a result of the action or inaction of the manufacturer.

Pursuing a Vioxx lawsuit can be a tricky task; most drug companies either attempt to settle, and while a Vioxx lawsuit can mean bad publicity if it goes to trial, it is possible that if the company drags Vioxx lawsuits out indefinitely, the plaintiff will be drained of resources and be forced to settle.

The pursuit of a a Vioxx lawsuit is a serious commitment on your part. If you feel strongly enough to commit your time and energy to making a claim, we want to help you. Please contact us now.



Official Announcement from Merck:

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. 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. 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." APPROVe was a multi-center, randomized, placebo-controlled, double-blind study to determine the effect of 156 weeks (three years) of treatment with VIOXX on the recurrence of neoplastic polyps of the large bowel in patients with a history of colorectal adenoma. The trial enrolled 2,600 patients and compared VIOXX 25 mg to placebo. The trial began enrollment in 2000. VIOXX was launched in the United States in 1999 and has been marketed in more than 80 countries. In some countries, the product is marketed under the trademark CEOXX. Worldwide sales of VIOXX in 2003 were $2.5 billion. Results of the VIGOR (VIOXX Gastrointestinal Outcomes Research) study, released in March 2000, demonstrated that the risk of gastrointestinal toxicity with VIOXX was less than with naproxen, but indicated an increased risk of cardiovascular events versus naproxen. However, in other studies including Merck's Phase III studies that were the basis of regulatory approval of the product, there was not an increased risk of cardiovascular events with VIOXX compared with placebo or VIOXX compared with other non-naproxen non-steroidal anti-inflammatory drugs (NSAIDs). Merck began long-term randomized clinical trials to provide an even more comprehensive picture of the cardiovascular safety profile of VIOXX. "Merck has always believed that prospective, randomized, controlled clinical trials are the best way to evaluate the safety of medicines. APPROVe is precisely this type of study - and it has provided us with new data on the cardiovascular profile of VIOXX," said Peter S. Kim, Ph.D., president of Merck Research Laboratories. "While the cause of these results is uncertain at this time, they suggest an increased risk of confirmed cardiovascular events beginning after 18 months of continuous therapy. While we recognize that VIOXX benefited many patients, we believe this action is appropriate." Merck has informed the U.S. Food and Drug Administration and regulatory authorities in other countries of its decision. The company also is in the process of notifying health care practitioners in the United States and other countries where VIOXX is marketed. Patients who are currently taking VIOXX should contact their health care providers to discuss discontinuing use of VIOXX and possible alternative treatments. In addition, patients and health care professionals may obtain information from www.merck.com and www.vioxx.com, or may call (888) 36-VIOXX (1-888-368-4699). The results of clinical studies with one molecule in a given class are not necessarily applicable to others in the class. Therefore, the clinical significance of the APPROVe trial, if any, for the long-term use of other drugs in this class, consisting of COX-2 specific inhibitors and NSAIDs, is unknown. The company will work with regulatory authorities in the 47 countries where ARCOXIA is approved to assess whether changes to the prescribing information for this class of drugs, including ARCOXIA, are warranted. Merck is continuing to seek approval for ARCOXIA in other countries, including the United States. Merck will continue its extensive clinical program to collect additional longer-term data for ARCOXIA, its medication for arthritis and acute pain. With regard to financial guidance, prior to today's announcement, Merck remained comfortable with its 2004 earnings per share guidance of $3.11 to $3.17. The company currently expects earnings per share to be negatively affected by $0.50 to $0.60 as a result of today's announcement. This estimate includes foregone sales, writeoffs of inventory held by Merck, customer returns of product previously sold and costs to undertake the pullback of the product. Included in this cost estimate is the expectation of foregone fourth quarter sales of VIOXX of $700 million to $750 million. In addition, Merck expects that worldwide approximately one month of inventory is held by customers and will be returned. At this point it is uncertain which of these costs will be recorded in the third quarter and which will be recorded in the fourth quarter. Therefore, at this point, Merck is retracting the third quarter guidance it had previously provided. Merck will report third-quarter earnings on Oct. 21. At that point, the company will provide additional information regarding the costs for product withdrawal. About Merck Merck & Co., Inc. is a global research-driven pharmaceutical company. Merck discovers, develops, manufactures and markets a broad range of innovative products to improve human and animal health, directly and through its joint ventures. Forward Looking Statement This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the cautionary statements in Item 1 of Merck's Form 10-K for the year ended Dec. 31, 2003, and in its periodic reports on Form 10-Q and Form 8-K (if any), which the company incorporates by reference.

VIOXX® (rofecoxib) is a registered trademark of Merck & Co., Inc.