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VIOXX: What the websites are telling us…

Kyle Garrett

 

 

 

 

 

 

 

 

 

What is VIOXX?

VIOXX, a nonsteroidal anti-inflammatory drug (NSAID), is a new pain-relief medicine that specifically targets people with osteoarthritis, rheumatoid arthritis, acute pain, and primary dysmenorrhea (painful menstrual cramps).  The official medical term for VIOXX is rofecoxib.  VIOXX, however, is used mainly for patients suffering from osteoarthritis, and all one has to do is take one pill for 24-hour relief from pain.  VIOXX helps control pain to help you be able to do “the simple things, like taking a walk or bending down to build sand castles with your child” (www.vioxx.com).  VIOXX has been clinically proven to relieve pain, as clinical studies as long as 21 months proved it effective.  Osteoarthritis patients took the pills once daily in these studies and were free from pain throughout the duration of the research studies.

 

 

What is osteoarthritis? What other treatments are there besides VIOXX?         

Osteoarthritis is a joint disease that leads to pain and stiffness in the bones and joints.  Men and women all over the world suffer from this disease and the pain is most commonly found in the fingers, feet, back, knees, and hips.  Doctors have also given other recommendations to do along with taking VIOXX in order to reduce pain induced by osteoarthritis.  Many of these recommendations have to do with diet, by maintaining a recommended weight to reduce stress on the knees and feet, and exercise, increasing movement, strength, endurance, and flexibility while reducing fatigue.  Other recommendations from doctors are to heat aching muscles and joints to relax them and to use ice on affected areas of the body to reduce pain and swelling.  Finally, being able to adjust to the changes that osteoarthritis brings is of great importance, and it is necessary to keep a positive attitude and find others who can share in your struggles (for more information, see www.vioxx.com).

           

What are the side effects related with VIOXX?

There are, unfortunately, many side effects associated with this new drug.  First, patients taking VIOXX have reported heart attacks and similar serious events during treatment.  There are also such reported side effects as stomach and intestinal bleeding, which, as warned by www.vioxx.com, can lead to hospitalization or death.  In addition, other severe side effects associated with this drug are allergic reactions, kidney problems or failure, and liver failure or problems including hepatitis and jaundice.  There are also some less serious side effects such as respiratory infection, headaches, dizziness, hypertension, nausea, back pain and more.  A complete listing of side effects can be found at www.vioxx.com, which also warns that anyone experiencing these side effects while taking VIOXX should consult his or her doctor immediately.

 

 

 

 

 

 

What is the technical information?

As far as the more medical, ‘technical’ information is concerned, there are websites that describe the pill scientifically.  One of those sites is http://www.rxlist.com/cgi/generic/rofecox.htm.  On this site, one learns that VIOXX is an off-white powder whose empirical formula is C17 H14 O4 S, and the inactive ingredients in the pill are croscarmellose sodium, hydroxypropyl cellulose, lactose, magnesium stearate, microcrystalline cellulose and yellow ferric oxide.

 

How much is VIOXX? Is it easy to buy? Where can I find it?

            VIOXX is also easy to buy! You can buy it on any of numerous websites that give online medical questionnaires, and it will be to your house in less than 24 hours.  The site http://vioxx.com-online.us gives much of the same information as www.vioxx.com, but it also makes it easy for you to buy the medicine.  You can get a free medical consultation on-line and order 50 25-mg pills for $216.  There are, however, other websites that are offering VIOXX (or the generic form of rofecoxib) for much less money.  One site, http://www.homepharmacydirect.com/drugs/painrelief/vioxx.htm boasts prices of VIOXX as follows: $187 for 50 25-mg pills and $699 for 200 25-mg pills.  Another site, this one from Canada, offers 100 25-mg tabs at $122.59.  You can find this site at www.candrugstore.com/drugsearchAtoZlist.asp?Search=vioxx.  And the best prices that I could find online, at about $0.65/pill, offer the generic form of VIOXX, $58.50 for 90 25-mg pills.  This site is www.shoprxonline.com/vioxx/.  I am certain, however, that one could find this new drug for even cheaper with all of the web sites out there; it is also worth repeating that to obtain this ‘prescription’ drug, one has to do no more than fill out a simple medical questionnaire (about 8 to 10 questions) and then place the order.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

VIOXX: What the research tells us…

 

How effective is VIOXX?

 

            In a study by Katz et al. (2003), they focused on determining the effectiveness and safety of rofecoxib as compared to a placebo in the treatment of chronic low back pain (CLBP).  Even though NSAIDs are commonly prescribed for CLBP, they had not yet been proven effective and there is also a concern over tolerability in the patient.  In this study, CLBP patients were randomized in three different groups: rofecoxib 25 mg, 50 mg, or placebo once daily.  The placebo group was the control group, and patients were tested over a period of 4 weeks for different symptoms, function, and response to the therapy.  Katz et al. (2003) found that rofecoxib was indeed successful in reducing low back pain in adults for both the 25 mg group and the 50 mg group.  They also found that most patients tolerated the medicine well, with the 25 mg treatment somewhat better tolerated than the 50 mg.  Minor adverse drug effects reported were headache, diarrhea, and upper respiratory infection.  The efficacy of the treatment was determined by a number of different measures, including symptoms, back-related function, physical well being, and overall response to the therapy, and most patients reported at least some level of pain relief.

            In another study on the efficacy of rofecoxib, Ahuja, Singh, & Singh (2003) gave an update on the status of VIOXX in pharmacies and why the FDA had approved it as a drug to be prescribed by doctors.  This study focused much attention on the chemical makeup of rofecoxib and the more technical information, including how it is absorbed into the body and used by the body.  Ahuja et al. (2003) did, however, come up with the many of the same conclusions as Katz et al. (2003).  Also, as is stated on the www.vioxx.com website, rofecoxib is useful in treatment of osteoarthritis, rheumatoid arthritis, acute pain, and primary dysmenorrhea.  Because one can tolerate rofecoxib in the gastrointestinal tract, Ahuja et al. (2003) also state that rofecoxib is a safer and more cost-efficient option in high-risk patients.

 

What are some dangers associated with rofecoxib?  How can those be prevented?

 

            Verrico, Weber, McKaveney, Ansani, and Towers (2003) published a study of their research on the adverse drug events (ADEs) involving COX-2 inhibitors such as rofecoxib.  Their objective was to determine the types and severity of ADEs in patients and also to increase awareness to the general public of risk factors that are associated with these drugs.  The study looked at 24 patients with 48 ADEs amongst them and compared patients taking a COX-2 inhibitor with patients taking a non-selective NSAID.  All patients who received the COX-2 inhibitor had increased risk to experiencing an ADE, while 91% of those receiving a non-selective NSAID had increased risk.  The study also indicated specific groups who were at higher risk to experience an ADE associated with rofecoxib.  These groups included elderly patients (65-years old and older), patients with hypertension, congestive heart failure or renal impairment, and patients with a gastrointestinal ulceration or bleeding history.  Verrico et al. (2003) concluded that physicians should be aware of these high risk groups and should evaluate patients for the proper precautions before prescribing rofecoxib or any other COX-2 inhibitor.

 

What is the cost effectiveness of rofecoxib?

 

            A Maetzel, Krahn, and Naglie (2003) study evaluated the cost effectiveness of rofecoxib as compared with naproxen, and celecoxib as compared with ibuprofen and diclofenac.  The analysis of cost effectiveness was based on a 5-year Markov model, and the research compared arthritis patients with an average risk of upper gastrointestinal (UGI) events to high-risk patients who had a prior history of a UGI event.  To measure the results, Maetzel et al. (2003) looked at the number of patients with UGI events, quality-adjusted life expectancy (QALY) and life expectancy.  The results showed that both rofecoxib and celecoxib are cost-effective in high-risk patients, including the elderly.  These results are based on a threshold of Can$50,000 per QALY gained (a quantity that was derived in the methods part of the experiment), which means that these high-risk patients were gaining quality of life for a cost that was not judged as too high.  However, in the average risk patients, the results were costs per QALY gained of Can$271,888, more than 5 times the established threshold.

            Another study, by Spiegel, Targownik, Dulai and Gralnek (2003), was very similar to the Maetzel et al. (2003) study and gives us similar results.  The purpose of this study was to determine if the risk reduction in GI complications by coxibs (like rofecoxib) offset its cost when compared with a less expensive, non-selective NSAID.  This study also looked at patients with osteoarthritis or rheumatoid arthritis and also used incremental cost per QALY gained as its measure.  From their findings, Spiegel et al. (2003) estimate that using rofecoxib will, on the average for all patients, be more cost effective only if the price per tablet is decreased by almost 90%.  They also found results similar to the Maetzel et al. (2003) study: in looking at average-risk patients, the cost of gaining 1 QALY was $275,809 per year; in examining the high-risk patients, the incremental cost of 1 QALY was significantly less, at $55,803.  When looking at patients who are at risk for GI events, rofecoxib is therefore cost effective in high-risk patients, but not so among patients who are at average-risk.

 

Conclusions

 

            It would be easy to get wrapped up in all of the positives given on many websites concerning VIOXX.  It even seems to be very easy to buy this new medicine that promises to reduce pain with only one pill a day.  However, in looking at the actual research information (and in looking at the official site, www.vioxx.com), one sees that this medicine is not for everyone.  VIOXX has proven to be effective, but there are many side effects that can occur in many different people.  Also, if someone is only at average risk for complications, it may be better to take a different medicine, such as a non-selective NSAID.  Finally, the best way to figure out if VIOXX is for you is to consult your doctor, to be honest with him or her about your symptoms and any previous medical conditions, and for you to let him or her help you make the best decision for your life and your health.

 

Ahuja, N., Singh, A., & Singh, B. (2003).  Rofecoxib: an update on physiochemical,

pharmaceutical, pharmacodynamic and pharmacokinetic aspects.  The Journal of

Pharmacy and Pharmacology, 55 (7), 859-894.

 

Katz, N., Ju, W.D., Krupa, D.A., Sperling, R.S., Bozalis Rodgers, D., Gertz, B.J.,

Gimbel, J., Coleman, S., Fisher, C., Nabizadeh, S., & Borenstein, D. (2003).

Efficacy and safety of rofecoxib in patients with chronic low back pain: results

from two 4-week randomized, placebo-controlled, parallel-group, double-blind

trials.  Spine, 28 (9), 851-859.

 

Maetzel, A., Krahn, M., & Naglie, G. (2003). The cost effectiveness of rofecoxib and

celecoxib in patients with osteoarthritis or rheumatoid arthritis.  Arthritis and

Rheumatism, 49 (3), 283-292.

 

Spiegel, B.M., Targownik, L., Dulai, G.S., & Gralnek, I.M. (2003).  The cost-

effectiveness of cyclooxygenase-2 selective inhibitors in the management of

chronic arthritis.  Annals of Internal Medicine, 138 (10), 795-806.

 

Verrico, M.M., Weber, R.J., McKaveney, T.P., Ansani, N.T., & Towers, A.L. (2003).

Adverse Drug Events involving COX-2 inhibitors.  The Annals of

 

 

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