Merck Sought to Revise Vioxx® Formula, News Sources Say
NEW YORK, NY -- July 1, 2005 -- Merck publicly downplayed the hazards of Vioxx® (rofecoxib), even though it knew that the arthritis drug could increase heart attack risk, internal company documents imply. The documents were inadvertently given to plaintiffs' counsel, and later leaked to the AP and other news sources.
In 2001, Merck applied for a patent to combine Vioxx® with another compound called "thromboxane synthase inhibitor," which is thought to protect the heart (Inquirer, June 22, 2005). Memos and documents, written in 2000, discussed a patent to reformulate Vioxx® to lower the risk of blood clots, heart attacks and strokes. In the same year, researchers published the Vioxx Gastrointestinal Outcomes Research (VIGOR) study, which showed that Vioxx® users greatly increased their risk of heart attacks and strokes compared to patients taking naproxen, a traditional pain medication (N Engl J Med. 2000 Nov 23; 343(21): 1520-8).
Merck continued to deny the link between Vioxx® and heart problems, however, urging company sales representatives to dodge tough questions about the drug. It also issued a press release that "confirmed the favorable cardiovascular safety profile of Vioxx." (See Merck Knew About Vioxx Risks Early On).
Merck finally withdrew Vioxx® from the market in September, 2004. This was in response to the APPROVe clinical trial, which treated colon cancer patients with the drug. Those who took Vioxx® had a much greater chance of developing serious heart conditions compared with those taking a sugar pill or placebo.
Vioxx® and Other COX-2 Inhibitors
Vioxx® is a nonsteroidal anti-inflammatory drug (NSAID) that blocks cyclooxygenase, an enzyme needed for the production of prostaglandins. Prostaglandins may cause inflammation and pain. Vioxx® interferes with the form of cyclooxygenase known as COX-2, and is therefore referred to as a COX-2 inhibitor. Before its recall, Vioxx® was approved to reduce the pain of osteoarthritis, rheumatoid arthritis, and migraine headaches. The drug was originally developed to limit gastrointestinal bleeding caused by other pain medications.
Celebrex® (celecoxib) and Bextra® (valdecoxib) are two other COX-2 inhibitors, both manufactured by Pfizer. The company withdrew Bextra® from the market at the request of the Food and Drug Administration (FDA) in April of this year. Bextra® may increase the risk of heart attacks and strokes, especially among patients who have undergone coronary bypass surgery. It also has been linked to skin allergies and Stevens-Johnson syndrome, a painful blistering of the skin and mucous membranes that sometimes proves fatal. Although Celebrex® is still available, it has also been associated with heart problems.
Evaluating Your COX-2 Case
Brayton Purcell is evaluating cases of heart attacks, strokes, and blood clots that are linked to COX-2 arthritis drugs. If you or a loved one has had these conditions while taking Bextra® or Celebrex® or after discontinuing either medication, please feel free to contact us.