Login
Subscribe
In another example of the irrationality of prescription drug prescribing in the U.S., Wall Street investors predict that the DO NOT USE non-steroidal anti-inflammatory drug (NSAID) meloxicam (MOBIC) will become a “blockbuster” drug. Meloxicam’s new found success appears to be due to the serious cardiovascular problems associated with the use of the NSAIDs celecoxib (CELEBREX) and valdecoxib (BEXTRA; see Worst Pills, Best Pills News April 2001 and September 2004). Wall Street defines a “blockbuster” as a drug that sells over $1.0 billion per year. The term has nothing to do with the therapeutic value of meloxicam to patient care.
Sales of meloxicam increased to $258 million from a projected $100 million in the fourth quarter of 2004. This is an enormous waste of scarce healthcare dollars and a needless economic burden on consumers who must pay out-of-pocket for their drugs.
How could this happen? Since generic drug manufacturers do not promote their products to patients or physicians and the makers of patented drugs do, a possible explanation for meloxicam’s new economic status is that it remains the only NSAID still protected by a patent that has not been tainted by major cardiovascular safety problems. Too often physicians’ prescribing decisions are based on promotion rather than science.
Meloxicam is FDA-approved for the relief of the signs and symptoms of osteoarthritis and rheumatoid arthritis. It is not approved for the management of acute pain.
Meloxicam was approved in April 2000 by the Food and Drug Administration (FDA), making it the 23rd NSAID on the United States market. Meloxicam is not a new drug. It joins the list of old drugs first marketed in other countries that have been recycled in the U.S. Meloxicam has been available in the United Kingdom since September 1996, and has been promoted there as a selective COX-2 drug and thus supposedly safer NSAID — like celecoxib and valdecoxib — for the gastrointestinal (GI) tract. GI adverse effects are the most serious reactions seen with the NSAIDs including meloxicam, celecoxib and valdecoxib.
The FDA medical officer’s review reveals that an attempt was made to promote meloxicam as a safer COX-2 drug in this country, but the agency did not buy it. The medical officer wrote, “It was the agency’s position that there was insufficient pharmacology and endoscopy information to support a COX-2 mechanism of action for Meloxicam.” These reviews can be found on the FDA’s web site at http://www.fda.gov/cder/foi/nda/2000/20-938_Mobic.htm.
The August 1998 issue of Current Problems in Pharmacovigilance, a newsletter published by the British Medicines Control Agency and the Committee on Safety of Medicines, reported that in the first year and nine months of marketing experience with meloxicam in that country, there had been a total of 1,339 adverse reactions reported to the government for the drug. Of these, 41 percent (549) were GI adverse effects, 99 being reports of perforations, ulcers or bleeding, including five deaths. The British drug regulatory authorities required a major revision in the warnings for meloxicam because of these severe GI adverse effects.
The internationally respected Drug and Therapeutics Bulletin, the U.K.’s equivalent of our Medical Letter on Drugs and Therapeutics, said in its August 1998 issue that “There is no convincing evidence that the risk of the severest gastrointestinal events, namely peptic ulceration, perforation and bleeding, is lower with meloxicam than with other NSAIDs when given at equi-effective doses. Meloxicam has not been compared with ibuprofen [MOTRIN] which comes out best in most safety assessments.”
Meloxicam was compared to the older arthritis drugs piroxicam (FELDENE) and diclofenac (VOLTAREN) in studies submitted to the FDA. The FDA’s statistical reviewer concluded that there was no statistical difference in the effectiveness of meloxicam compared to these older drugs.
In addition to the risk of GI bleeding that may result in hospitalization and even fatal outcomes (see the box above), patients taking meloxicam should be informed of the warning signs and symptoms of liver toxicity: nausea, fatigue, lethargy, pruritus (itching), jaundice (yellowing of the eyes or skin), right upper quadrant tenderness (the location of the liver), and “flulike” symptoms. If these occur, patients should be instructed to stop treatment and seek immediate medical attention.
Serious allergic reactions have also been reported with meloxicam and the drug should be avoided in late pregnancy.
The maximum recommended daily oral dose of meloxicam is 15 milligrams per day. A 30-milligram-per-day dose was used in some clinical trials submitted to the FDA prior to meloxicam’s approval. Study of the 30-milligram dose was discontinued because of serious GI toxicity.
The retail cost of a 30-day supply of meloxicam at the maximum recommended dose of 15 milligrams per day is $109.40 at a popular Internet pharmacy. At the same pharmacy, the retail cost of a one month supply of ibuprofen, 120 tablets in the 800-milligram strength, is $14.98. This is a difference of $94.42 per month. Over one year, this adds up to a significant savings of $1,133.04.
Meloxicam is not approved for the treatment of acute pain. It is no more effective and no safer than older, less expensive drugs for arthritis that have been available for years.
What You Can Do
There is no medical reason why you should be taking meloxicam rather than an older, equally effective NSAID such as ibuprofen to manage arthritis.
