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 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.
Vioxx Settlement News:
Vioxx Settlement Announced - Nov 9, 2007
Merck & Co., Inc. has agreed to pay $4.85 billion to resolve Vioxx-related claims in which a claimant has suffered a heart attack, sudden cardiac death, or stroke.
After more than five years of hard-fought and difficult litigation, Merck has agreed to pay $4.85 billion, the largest pharmaceutical settlement in history, to resolve certain Vioxx-related claims involving plaintiffs who suffered a heart attack (including sudden cardiac death) or a stroke. Levin Papantonio's Troy Rafferty and his team of Vioxx lawyers - Pete Kaufman and Rachael Gilmore -- played an integral role in the in the mass tort litigation that led to Merck agreeing to settle these cases. Mr. Rafferty is known nationwide as one of the leading Vioxx lawyers. He is Co-Lead of Discovery litigation for the national Vioxx MDL proceeding in New Orleans, and he is one of the few attorneys in the country that has tried a Vioxx case before a jury.
The Settlement Program will settle the claims of thousands of qualified claimants who suffered a heart attack, ischemic stroke, or sudden cardiac death resulting from Vioxx. The settlement funds will be allocated among thousands of qualifying claims based upon an evaluation of each Qualifying Claimant's medical records by a Claims Administrator. We feel the Settlement Program is fair and that it provides qualifying clients the ability to be compensated for their injuries in the foreseeable future, rather than competing for a trial date with the thousands of other Vioxx cases pending nationally.
Details regarding the Settlement Program, including eligibility and qualification requirements, may be accessed by clicking on the following links:
- Vioxx Master Settlement Agreement
- Claimant Valuation Examples
- Description of Settlement
- Official Press Release - Vioxx Settlement Announced
- Vioxx Master Settlement Agreement - With Exhibits
Vioxx Pulled From Worldwide Market
September 30, 2004
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.