On September 30, 2004, Merck & Co., Inc. announced a voluntary withdrawal of Vioxx (rofecoxib) from the U.S. and worldwide market due to safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) in patients on Vioxx.

Vioxx, also known as Rofecoxib, is a selective cox-2 inhibitor used to treat pain associated with arthritis. Physicians may also prescribe Vioxx, available in tablet and liquid form, to relieve minor pain, headaches and menstrual discomfort. Approved by the the U.S. Food and Drug Administration (FDA) in May 1999, Vioxx is made by Merck & Co.

Minor side effects of Vioxx use include, but may not be limited to, upset stomach, dizziness, heartburn, vomiting and constipation. Numerous studies, including one sponsored by the drug's manufacturer, have found that Vioxx may increase a patient's risk of suffering a heart attack, stroke, or blood clot.

A March 2002 FDA report linked Vioxx to five cases of a nonbacterial type of meningitis. According to the FDA, several patients developed aseptic meningitis while using the arthritis drug.

In May 2002, a report published in the Journal of Bone and Mineral Research revealed that inhibiting cox-2 may also impede bone repair. Cox-2 reportedly assists bone-forming stem cells in the healing process.

The makers of Vioxx received more damaging news in August 2004 when a FDA-funded study found that Vioxx increases the risk of heart attack and cardiac death more than Celebrex. The study, which was released at an epidemiologist conference, found that both high and low levels of the medication increase the risk for cardiovascular events. According to the study, patients taking the highest doses increase their risk of heart attack more than three-fold.

On September 30, 2004, Merck & Co., Inc. announced a voluntary withdrawal of Vioxx (rofecoxib) from the U.S. and worldwide market due to safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) in patients on Vioxx.

In February 2005, the Wall Street Journal reported that a safety committee monitoring Vioxx before its withdrawal had early data from a clinical trial indicating users could be at increased risk of heart problems after four months of use. The committee, which included a Merck employee, reportedly kept the trial going to see if Vioxx could reduce colon polyps.

Shortly after the release of the Wall Street Journal article, a whistleblower speaking to a FDA panel reviewing the safety of painkillers revealed that up to 10,000 additional Vioxx-related heart attacks may occur. The physician told researchers that patients involved in clinical trials are usually healthier than real world patients, which caused physicians to underestimate Vioxx's actual impact on users.

A study conducted by a U.S. private health insurance group has confirmed fears that cox-2 inhibitors cause serious cardiovascular events. In February 2005, Wellpoint Inc. released a study that found Bextra, Celebrex and Vioxx increase the risk of heart attack or stroke in users. According to the research, the risk of heart attack was 53 percent higher than normal for patients taking Bextra, 19 percent higher for those taking Celebrex and 23 percent higher for patients taking Vioxx. The study reportedly found no increase in cardiovascular events in patients taking traditional anti-inflammatory medications.

Concluding three days of meetings reviewing the safety of cox-2 inhibitors, advisers told FDA officials in February 2005 that Celebrex, Bextra and Vioxx, while posing an increased risk for cardiovascular events, should stay on the market because the drugs' benefits outweigh their potential dangerous side effects. The advisory panel voted 31-1 to keep Celebrex on the market, 17-13 to keep Bextra available to patients and favored Vioxx by a vote of 17-16. Vioxx is currently not for sale after being recalled in September 2004. The FDA does not have to follow the panel's recommendations but generally does.

See your doctor if you have concerns about the safety of Vioxx or if you have experienced serious side effects associated with the drug.

If you or a family member has been injured, abused or otherwise harmed, you should contact one of our California attorneys who can help you protect your legal rights. Please keep in mind that there may be time limits within which you must commence suit.

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