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How To Address The Fallout Over COX-2 Drugs With Patients
Patient Education:
How To Address The Fallout Over COX-2 Drugs With Patients

- By Mona M. Counts, PhD, CRNP, FNAP, FAANP, and Regina A. Mayolo


       As health care providers, we have all had someone walk into our office in the last year, questioning why he or she could no longer get Bextra or Vioxx. Granted, the recalls of these drugs have affected all prescribers. However, for primary care practitioners, it has had a greater impact than any other recall in recent memory.


       Some of this is due to the nature of arthritis and the type of patients we serve. Primary care providers see patients throughout their lifespan and arthritis is equally indiscriminate, affecting people of all ages including children. In general, arthritis is a challenge to any practitioner trying to assist folks in maintaining their mobility and independence. This can be particularly challenging given the cultural misperception that many people think arthritis is normal and comes with age. However, three out of five of those afflicted with arthritis are under the age of 65.
       When new drugs are released on the market, some are found to be extremely effective for the conditions they are purported to treat. When the COX-2 inhibitors were released with much fanfare and direct-to-consumer marketing, many patients requested prescriptions for the COX-2 drugs when they presented to the office. The effectiveness of these medications encouraged providers to prescribe them for multiple patients with similar conditions. However, when those drugs were recalled, it presented the current problems of how to address those conditions without the aforementioned medications in our armamentarium.

Case Studies: Offering Alternatives To COX-II Inhibitors
       Consider the following case studies. Joyce is a 67 year-old female who had significant osteoarthritis to the point where it severely limited her ability to perform usual daily activities.
       She had tried multiple NSAID regimes over the years without positive outcomes. The patient presented to the office one day and was given a prescription of Bextra at the lowest possible dose. In three days, she called and was very excited because she had decreased pain, increased mobility and was becoming actively involved again in her previous activities.
       In April of this year, she tried to refill her prescription and called the clinic in a panic because Bextra had been taken off the market and she could not get her prescription filled. After we consulted with the patient, she agreed to return to the most effective NSAID regime she had previously but complained that it did not meet the efficacy that she had experienced with Bextra. She said she would continue with this treatment protocol until the fervor over the withdrawal of the COX-2 drugs was sorted out. She proceeded to call the office on a weekly basis, asking if there was any news regarding the restoration of these drugs and when they could be considered “safe” to use again. When Celebrex was rereleased at a recommended lower dose, we gave the patient a new prescription for this medication.
       Currently, she still contends that she felt better, was more active and did better on the Bextra and is still waiting for it to be returned to the market.
       George is a 71-year-old male who has been a farmer his entire life. He experienced significant arthritic changes that made him look (in his own words), “just like my grandfather.”
       Prior to coming to the clinic, he had been self-medicating for almost 25 years by taking four to five aspirin a day to manage his symptoms. He presented to the office and, during a routine screening, we found that he had hem-positive stools. A subsequent colonoscopy found mild colitis and no evidence of polyps or cancer.
       When we advised him to stop taking the aspirin, he was not readily supportive of this recommendation. We offered a COX-2 inhibitor because of its effectiveness with arthritis and its sparing of the prostaglandins. He started using it, stopped his aspirin, and was able to continue farming effectively and without pain until the drug was removed from the market.
       At this point, George was distraught and wanted to return to his aspirin so he could keep moving. Although we advised the patient against this, he elected to restart his aspirin but began taking Maloxx prior to taking the aspirin. Recently, we initiated a low dose prescription of the rereleased Celebrex. His stools remain hem-negative.

While exercise is important for flexibility and joint mobility, clinicians should remind patients to avoid getting too tired or they may have increased stress.


Emphasizing The Benefits Of Appropriate Exercise, Diet And Stress Management
       As is evident in these case studies and others, the impact of the recall is overwhelming because the patients found the drugs to be effective and now they cannot have them. Several patients have admitted that they have sought the medication through the Internet, purchasing it from questionable sources and companies with questionable quality control.
       What can providers do? The only reasonable solution is to switch patients to safer treatments and multiple modalities but this can also be a challenge. Mention diet and exercise to the average American and you will probably not hear a cheerful response.
       However, in lieu of potentially harmful drugs, emphasizing therapeutic lifestyle changes is probably the most effective alternate treatment for arthritis for most patients. Rest, exercise, diet and stress management all play a significant role in helping patients with arthritis improve their quality of life.
       For instance, patients may combine range-of-motion exercises, strengthening exercises and endurance exercises with Tai-Chi, which has the additional benefit of reducing stress. However, it is important to have a balance between rest and exercise. While exercise is important to restore flexibility, stop stiffness and improve joint mobility, one must remind patients to avoid getting too tired or they may experience an increase in stress. In addition, a secondary effect of arthritis is fatigue so these patients must balance exercise with rest to avoid aggravating the disease process.
       Weight control is also extremely important for patients with arthritis. Excessive weight puts stress on the joints and creates a self-fulfilling prophecy of “no mobility.” However, everyone, including patients with arthritis, can benefit from a healthy, well-balanced diet that includes plenty of variety in vegetables, fruits and whole-grain foods. There are also many dietary supplements that are recommended for individuals with arthritis. Several of our patients have reported success with nutritional supplements like vitamins, minerals omega-3 fatty acids, and glucosamine and condroitin.
       Avoiding high and low carbohydrate overload is good because the sugar highs can wreak havoc with arthritis and there may be additional consequences for those with specific arthritic conditions. For example, for patients with gouty arthritis, it is even more important to avoid purines.
In Conclusion
       Given that there are more than 100 types of arthritis, the treatment method must be one that is individually appropriate for each patient and his or her specific condition. A diet or exercise program that the patient won’t follow is about as effective as a drug the patient won’t take. Noting the patient likes and dislikes in any recommended treatment plan will maximize the chances of patient adherence to the regimen and ultimate treatment effectiveness.
       For providers, it is vastly rewarding when they have helped to restore a patient’s quality of life and, with a little effort, they can accomplish this even without Vioxx or Bextra.


1. About Health Canada. (2005). Health Canada has asked Pfizer to suspend sales of its drug Bextra™ and informs canadians of new restrictions on the use of Celebrex®. Retrieved September 26, 2005, from http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/2005/2005_17_e.html
2. Arthritis Foundation. (2005). Popular Drugs Affect Heart Attacks. Retrieved September 26, 2005, from http://www.arthritis.org/resources/news/news_cox2inhibitors.asp
3. Center for Drug Evaluation and Research, U.S. Food and Drug Administration. (2005). COX-2 Selective (includes Bextra, Celebrex, and Vioxx) and Non-Selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). Retrieved September 26, 2005, from http://www.fda.gov/cder/drug/infopage/COX2/list
4. Lewis, Carol. (2005). Arthritis: Timely Treatments for an Ageless Disease. Retrieved September 26, 2005, from http://www.mamashealth.com/bodparts/ arhtreat.asp
5. Merck & Co., Inc. (2005). Statement Issued by Dr. Peter S. Kim at the FDA Advisory Committee Meeting. Retrieved September 26, 2005, from http://www.vioxx.com/rofecoxib/vioxx/consumer/index.jsp
6. Pfizer, Inc. (2005). Important news about Bextra. Retrieved September 26, 2005, from http://www.
bextra.com
7. The Telegraph. (2005). Arthritis blow to Pfizer – Bextra side effects outweigh benefits, says US watchdog. Retrieved September 26, 2005, from http://www.telegraphindia.com/1050408/asp/
foreign/story_4588945.asp

Arthritis Practitioner - ISSN: 1 - Volume 1 - Issue 4 - November 2005 - Pages: 10 - 11



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November 20, 2008

Emerging Concepts In Treating Rheumatoid Arthritis

A complimentary CME Webcast Event

To register for this Web Archive program, click on Complimentary CME Webcast Event


This activity is for nurse practitioners, physician assistants, rheumatologists and internal medicine physicians who treat patients with rheumatoid arthritis (RA).


Panelists/Lectures

"What You Should Know About Treating Early RA"
Nathan Wei, MD
Clinical Director
Arthritis and Osteoporosis Center
Frederick, Md.

"A Closer Look At The Efficacy And Safety Of Combination Therapy With Anti-TNF Agents"
Philip Mease, MD
Clinical Professor
University of Washington
School of Medicine
Chief, Rheumatology Clinical Research
Swedish Hospital Medical Center
Seattle

"What The Studies Reveal About Emerging Therapies For RA"
Salahuddin Kazi, MD
Chief of Rheumatology
Presbyterian Hospital
Dallas,Tx.

This activity is supported by an educational grant from Genentech and Biogen Idec. The activity is sponsored by the North American Center for Continuing Medical Education (NACCME).


Current Insights On Combination Therapy For Rheumatoid Arthritis

A complimentary CME Webcast Event
ON DEMAND
(Q&A with panelists to follow lectures)

To register for this Webcast program, click on Complimentary CME Webcast


This activity is geared to physicians, rheumatologists, nurses, physician assistants and nurse practitioners who treat rheumatoid arthritis.

Agenda And Faculty

“Treating RA: The Shift To A More Aggressive Therapeutic Approach”
Linda Davis, MHS, PA-C
Assistant Professor
University Of North Texas Health Science Center

“What The Literature Reveals About Combination Therapy”
Kevin M. Latinis, MD, PhD
Division of Allergy, Clinical Immunology and Rheumatology
University of Kansas Medical Center

“New Biologic DMARDs: Can They Have An Impact?”
Salahuddin Kazi, MD
Chief of Rheumatology
Presbyterian Hospital
Dallas, Texas

This activity is supported by an educational grant from Bristol-Myers Squibb. The activity is sponsored by the North American Center for Continuing Medical Education (NACCME).


A Guide To Viscosupplementation For Osteoarthritis Knee Pain

A complimentary CME Web Archive Event

To register for this Web Archive program, click on Complimentary CME Web Archive Event


This activity is geared to physicians, nurses, physician assistants and nurse practitioners who treat osteoarthritis.

Agenda And Faculty

“A Closer Look At The Role Of Intraarticular Injections”
Frank Caruso, PA-C
Physician Assistant
Wake Forest University Baptist Medical Center
Winston-Salem, NC

“What The Literature Reveals About Viscosupplementation”
Nathan Wei, MD
Clinical Director
Arthritis and Osteoporosis Center
Frederick, MD

“Mastering The Technique Of Intraarticular Injections”
Mike Rudzinski, PA-C
Physician Assistant
Buffalo Veterans Affairs Medical Center
Buffalo, NY

This activity is supported by an educational grant from Genzyme.
The activity is sponsored by the North American Center for Continuing Medical Education (NACCME).



A Complimentary CME Webcast Event

A Guide To Infusion Therapy For Patients With Rheumatoid Arthritis

A Complimentary, On-Demand CME Webcast

To register for this Webcast program, click on Complimentary CME Webcast Event


This activity is geared to physicians, nurses, physician assistants and nurse practitioners who treat rheumatoid arthritis.

AGENDA and FACULTY

"Reviewing The Role of DMARDs In Treating RA"
Don Flinn, PA-C
Physician Assistant, McBride Clinic, Oklahoma City, Ok.
Vice-President, Society Of Physician Assistants In Rheumatology

"Assessing The Potential of Biologic Therapies"
Mark Genovese, MD
Associate Professor of Medicine
Division of Immunology And Rheumatology
Stanford University School Of Medicine

"What You Should Know About Infusion Therapy"
Nathan Wei, MD
Clinical Director
Arthritis and Osteoporosis Center
Frederick, Md.

This activity is supported by an educational grant from Bristol-Myers Squibb.

The activity is sponsored by the North American Center for Continuing Medical Education (NACCME).


Educational Monographs

Current Concepts In Pharmacological Management Of Juvenile Idiopathic Arthritis

In a CME/CE roundtable discussion, expert panelists review the subtypes of JIA, keys to patient adherence and insights on treatments ranging from NSAIDs and methotrexate to emerging biologic agents.

This CME monograph is supported by an educational grant from Abbott Laboratories. It is sponsored by the North American Center for Continuing Medical Education (NACCME).