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FDA Directive: Stronger Warning Labels for Some Pain Medications
On April 7, 2005, taking into account
recommendations of Advisory Committee, FDA issued following directives:
•Bextra, a COX-2 specific inhibitor manufactured by Pfizer, was withdrawn from market.
•All prescription NSAIDs must revise their labeling to include a “black box” warning that highlights potential increased risk for cardiovascular (CV) events as well as potentially life threatening gastrointestinal (GI) bleeding associated with these drugs. Celebrex, only COX-2 specific inhibitor remaining on 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 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 potential for increased CV risk, FDA also announced that all NSAIDs must conduct and submit to 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 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 It’s Important to Treat Arthritis
Arthritis affects approximately 66 million Americans and is nation’s 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 breakdown of cartilage that causes 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 Aleve website at www.aleve.com. For more information on arthritis pain relief, visit www.arthritis.org.
R.L. Fielding writes on a number of subjects.
