How Cox-2 Selective and Non-Selective NSAIDs Are Legally Regulated
Non-steroidal anti-inflammatory drugs (NSAIDs) are drugs used to manage pain and relieve the symptoms of various medical conditions. NSAIDs are typically divided into two categories: Cox-2 selective NSAIDs and non-selective NSAIDs. All NSAIDs are regulated by the Food and Drug Administration (FDA) and may be available over the counter or by prescription. In 2005, the FDA's Center for Drug Evaluation and Research considered the risk/benefit profile of Cox-2 selective drugs and the cardiovascular risks of all NSAIDs. The results of this study prompted the FDA to impose stricter standards on the distribution and marketing of selective and non-selective NSAIDs.
Cox-2 selective NSAIDs include the drugs valdecoxib (Bextra), celecoxib (Celebrex) and rofecoxib (Vioxx).
Bextra. Bextra is a prescription drug used to relieve the symptoms of osteoarthritis, rheumatoid arthritis, and painful menstrual cycles. On April 7, 2005, the FDA asked Pfizer to voluntarily remove Bextra from the market. This request was based on several factors, including reports of serious skin reactions in patients using Bextra, and a lack of adequate data regarding the effects of Bextra on the cardiovascular system.
Celebrex. Celebrex is prescribed to relieve the symptoms of osteoarthritis, rheumatoid arthritis, and painful menstrual cycles. Celebrex is also used to manage acute pain in adults and to reduce the number of colorectal polyps in patients with Familial Andenomatous Polyposis. While taking Celebrex can potentially damage a patient's cardiovascular and gastrointestinal systems, the FDA determined that the benefits of Celebrex outweigh any possible side-effects. The FDA requires, however, that Celebrex be packaged with a boxed warning that includes information regarding the potential risks of taking Celebrex, as well as a label that encourages doctors prescribing the drug to discuss alternative treatment options with patients and to prescribe the lowest effective dose for the shortest duration possible.
Vioxx. Vioxx, like Bextra and Celebrex, was developed to relieve the symptoms of arthritis, acute pain and painful menstrual cycles in adults. In September 2004, Merck voluntarily withdrew Vioxx from the market after studies revealed that regular use of Vioxx may increase the risk of suffering from a heart attack or stroke.
Non-selective NSAIDs include a number of drugs that may be obtained by prescription or over the counter. Common non-selective NSAIDs include Ibuprofen (Advil, Motrin, etc.) and Naproxen (Aleve, Naprosyn, etc.). Available data shows that continuous use of non-selective NSAIDs may result in damage to the cardiovascular and gastrointestinal systems. However, long-term clinical trials have not been conducted with most non-selective NSAIDs. As a result of these risks, the FDA has imposed regulations on the distribution of prescription and non-prescription NSAIDs.
Prescription Non-Selective NSAIDs. The FDA requires prescription non-selective NSAIDs to include a boxed warning regarding the potential dangers of taking the drug, a contraindication for patients who have recently undergone coronary artery bypass surgery, and a medication guide that sets forth all potential adverse effects of the drug and encourages patients to discuss all treatment options with their physician.
Non-prescription non-selective NSAIDs. The FDA requires non-prescription NSAIDs to contain specific information regarding the potential risks associated with taking the drug, information regarding when patients should seek the advice of a physician before using the drug, reminders regarding limiting dosage and duration of use, and a warning about potential skin reactions.