VIOXX Recall

Vioxx, or known by its generic drug name rofecoxib, is a pain reliever drug developed and manufactured by Merck and Co, a large pharmaceutical company. A Vioxx Recall occurred on September 30, 2004. Officials from Merck voluntarily recalled Vioxx from the market due to side effects related to increased rates of blood clots (thrombosis), heart attack and strokes among Vioxx users. Some reports suggest that the cardiovascular side effects of Vioxx could have caused as many as 100,000 hospitalizations, 27,000 heart attacks and possibly as many as 10,000 to 15,000 deaths. Other pain killing drugs in the same drug class as Vioxx, such as Celebrex and Bextra may also induce myocardial cardiovascular side effects. Neither Celebrex nor Bextra have been recalled.

Vioxx was approved by the Food and Drug Administration (FDA) in 1999 as a pain relief and anti-inflamation treatment for osteoarthritis, severe back or joint pain in adults and for moderate to severe menstrual pain. Vioxx was developed during the last few decades as an alternative to other pain relievers. Studies indicate that Vioxx eliminates or reduces the intestinal irritation, stomach ulcers and other gastrointestinal side effects associated with the "Aspirin type" drugs. Although it is not uncommon for long-term Vioxx users to suffer from these types of side effects, they occur at a lower rate than with other types of pain relievers.

Vioxx has been prescribed and sold worldwide, with Merck representatives offering free samples to many physicians. Physicians would distribute samples and then write Vioxx prescriptions for long-term use. Since many Vioxx users had chronic illnesses, such as arthritis, Vioxx was taken over extended time periods. In essence, many patients started taking the drug, and never stopped, in order to continue the drug's beneficial affects for the reduction of pain and inflammation. It is estimated at the time of the recall; as many as 2 million persons were taking Vioxx worldwide on a daily basis.

Back to top

Vioxx Is a COX-2 Inhibitor Drug

COX-2 inhibitor drugs, such as Vioxx, were thought to represent a breakthrough in pain relief. Many commonly used pain killers, such as Aspirin and ibuprofen (Motrin), cause stomach and intestinal irritation when they are taken over extended time periods. Considerable research has been accomplished to discover pain killing drugs that do not have these intestinal side effects. Vioxx is a member of a class of drugs known as COX-2 inhibitors. These drugs are designed to alleviate the pain and swelling associated with inflammation, while at the same time reduce the stomach and intestinal side effects associated with Aspirin, ibuprofen and other types of pain relievers.

COX-2 inhibitor types of drugs inhibit the production of certain chemicals (enzymes) in the body known as the COX-2 enzymes. The focus of drug companies' research related to the COX-2 enzymes has been primarily on the role these enzymes play in processes of pain, inflammation and swelling. But in addition to involvement in pain and inflammation, research data suggests that COX-2 enzymes, along with the other type of COX enzymes, are important for maintaining proper balance in the heart and cardiovascular system. (COX enzymes are explained more fully in another section of this website.) Apparently, in addition to blocking the COX-2 effects related to pain and inflammation, Vioxx also blocks the beneficial balancing effects that the COX-2 enzymes have on the heart, arteries and veins. The heart attacks and stroke side effects of Vioxx are most likely related to the Vioxx disrupting the beneficial aspect of the COX-2 enzymes.

Back to top