Complications with the Use of Vioxx

Millions of people around the world suffer from pain due to several illnesses and ailments. Several governments and organizations, therefore, recognized the need for helping those people to overcome pain in an effective and non – harmful way.

Vioxx®, a non-steroidal anti-inflammatory drug (NSAID) was initially used for the treatment of signs and symptoms of menstrual problems in women, osteoarthritis, and for managing acute pain. The drug was used for the treating the symptoms of rheumatoid arthritis in children and adults. Vioxx is a prescription drug manufactured by Merck & Co. It was available in both pill and liquid from.

In May 1999, the U.S. Food and Drug Administration approved Vioxx to treat pain. Vioxx belongs to the group of NSAIDs called COX-2 inhibitors or Coxibs. COX – 2 inhibitors also include the drugs Bextra and Celebrex. Vioxx blocks the COX – 2 enzymes responsible for causing pain and inflammation linked with aforementioned conditions, especially arthritis.

Vioxx is also associated with nonselective NSAIDs like naproxen and ibuprofen. NSAIDs hinder COX- 2, an enzyme associated to inflammation and pain. Difference between over the counter pain reliever drugs and Vioxx is that it does not reduce COX -1, which helps to keep the stomach lining intact.

All over the counter and prescription medicines come with the risk of side effects. NSAIDs are effective in treating the pain of aforementioned illnesses. However, Vioxx and other COX-2 drugs are associated with some serious side effects. These include the following side effects:

• Stomach ulcers
• Nausea
• Fatigue
• Itching
• Flu like symptoms
• Liver damage
• Vomiting
• Loss of appetite
• Yellowing of eyes or skin
• Dark urine

COX-2 drugs like Vioxx are closely associated with an increased risk of cardiovascular events including the following:

• Blood clots
• Heart attack
• Strokes

In 2000, Merck & Co. conducted a study called the Vioxx Gastrointestinal Outcomes Research or “VIGOR” clinical trial. This study was conducted fro a period of year involving about 8,000 patients suffering from arthritis. During this trial, approximately, 4,000 patients consumed 50 mg of Vioxx daily and same no. of patients took Naproxen 1,000 mg daily.

This clinical study established that the patients taking Vioxx were at four time’s higher risk of developing heart attack to that of the patients taking Naproxen. Following are the cardiovascular events associated with the use of Vioxx:

• Myocardial infarction
• Ischemic stroke
• Peripheral venous
• Unstable angina
• Arterial thromboses
• Transient ischemic attack
• Sudden death

The results of VIGOR clinical trial alarmed the entire medical community as these drugs were widely used for the treatment of chronic pain. All prescription drugs have some negative side effects in few patients even if they are beneficial to a large no. of patients. However, it is proved that if side effects of drugs outweigh its benefits, it is not safe to prescribe it to any patient and should be taken off the shelves as soon as possible.

In February 2001, most of these factors were taken into consideration at the Arthritis Advisory Committee (AAC). FDA along with AAC declared to change the warning label of Vioxx. New warning label should highlight cardiovascular and gastrointestinal information.

In 2002, FDA asked all the manufacturers of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) to revise the labeling of their medications. The new labeling included “Black Box Warning”. Black box warning is the highest warning issued by the FDA to any drug.  It highlights the increased and life-threatening risk of cardiovascular events, gastrointestinal bleeding and ulcers linked with the use of such drugs.