Tag: U.S. Food and Drug Administration

Aleve, Vioxx, Celebrex, and Bextra: What You Need to Know About Arthritis Pain Medications
R.L. Fielding

Aleve, Vioxx, Celebrex and Bextra:What You Need To Know About Arthritis Pain MedicationsRecent controversy about the safety of pain medications for arthritis has left patients and health care professionals alike confused about which medications are safe to use. In fact, a recent survey by the Boston-based Rippe Lifestyle Institute indicated that many people with arthritis are suffering unnecessarily because they have stopped or reduced their use of pain relievers due to confusion about which drugs are considered safe.The survey also showed that now, more than ever, those with arthritis need to understand the benefits and possible side effects associated with all arthritis pain medications. In order to do so, people with arthritis, their caregivers and families must be familiar with recent news about the two types of drugs most commonly used to treat arthritis pain non-selective, non-steroidal anti-inflammatory drugs (NSAIDs), and another group of NSAIDs known as cyclooxygenase-2 (COX-2) specific inhibitors. COX-2 specific inhibitors vs. Other NSAIDsCOX-2 specific inhibitors are the newest members of the NSAID class of medications. Available by prescription only, they became widely used in recent years to reduce joint pain and swelling. COX-2 specific inhibitors work by selectively blocking, or inhibiting, one of the two enzymes associated with inflammation. Some experts think that this selective inhibition may be one reason for some of the negative side effects currently associated with COX-2 specific inhibitors.Non-selective NSAIDs were developed earlier than COX-2 specific inhibitors and have been widely used to relieve arthritis pain and inflammation for many years. Unlike COX-2 specific inhibitors, non-selective NSAIDs inhibit both major enzymes involved in the inflammatory process, COX-1 and COX-2. The non-selective NSAID category includes a number of different medications that are available in both prescription and over-the-counter (OTC) products.Timeline of EventsTo understand the current state of affairs, it is important to understand the sequence of events. The controversy started when a study published in the October 21, 2004, issue of the New England Journal of Medicine cited the COX-2 specific inhibitor, Vioxx as potentially causing major adverse events, including heart attack and stroke, among patients taking the drug. As a result, Merck (the drugs manufacturer) voluntarily withdrew Vioxx from the market. However, in the months following, the safety of the other available COX-2 specific inhibitors such as Celebrex and Bextra, as well as other arthritis pain medications in the non-steroidal anti-inflammatory (NSAID) class, were also called into question.Consequently, in February 2005, the US Food and Drug Administration (FDA) convened a special Advisory Committee, made up of members of the Arthritis and Drug Safety Advisory Committees, to review the cardiovascular safety of these arthritis pain medications.FDA Directive: Stronger Warning Labels for Some Pain MedicationsOn April 7, 2005, taking into account the recommendations of the Advisory Committee, the FDA issued the following directives: Bextra, a COX-2 specific inhibitor manufactured by Pfizer, was withdrawn from the market.All prescription NSAIDs must revise their labeling to include a black box warning that highlights the potential increased risk for cardiovascular (CV) events as well as the potentially life threatening gastrointestinal (GI) bleeding associated with these drugs. Celebrex, the only COX-2 specific inhibitor remaining on the US market, was included in this directive.All OTC NSAIDs (except aspirin) will be required to revise their labeling to include more specific information about the potential for GI and CV side effects, a stronger reminder to follow label instructions, as well as a warning about potential skin reactions.To further evaluate the potential for increased CV risk, the FDA also announced that all NSAIDs must conduct and submit to the FDA a comprehensive review and analysis of pertinent safety data from clinical trials. Aleve (naproxen sodium) is supported by clinical studies conducted to gain approval of naproxen as a prescription product and as OTC that do not provide any evidence of increased risk of cardiovascular events. Treatment Options: What Should Arthritis Patients Know?For some people who suffer from pain associated with arthritis, their symptoms can be managed with exercise, heat/cold therapy, joint protection, assistive devices, weight control, or in some severe cases, surgery. For others, medications are needed to help manage the symptoms associated with arthritis. When taken as directed OTC medications such as Aleve provide a safe and effective way to treat mild to moderate pain of minor arthritis. If patients have questions, they should consult their health care professional about which treatment option is most appropriate.Why Its Important to Treat ArthritisArthritis affects approximately 66 million Americans and is the nations leading cause of disability. There are over 100 different types of arthritis, and they all have different symptoms that vary in severity from person to person. The most common form of arthritis, osteoarthritis, is characterized by the breakdown of cartilage that causes the bones to rub together, resulting in pain, loss of movements and stiffness . Arthritis is usually a chronic condition. For more information on Aleve and naproxen, visit the Aleve website at www.aleve.com. For more information on arthritis pain relief, visit www.arthritis.org. About the Author
R.L. Fielding writes on a number of subjects.