News
You Have To Protect Yourself From Risks, Adverse Effects Of Medication
If you read this column, you'll better understand why you have to take an active, perhaps even aggressive role when it comes to the drugs you take and what you take them with. The point is made through one case, but it is a specific example of what is closer to the rule rather than the exception.
(...) The FDA failures were obvious and open, such as permitting fine print on drugs used by those likely to have failing vision, not getting the right directions and warnings on even the most commonly used drugs such as aspirin, and failure to put proper first aid advice on products that are poisons. Problems that should have been resolved in 30 minutes would sometimes take 30 years. Hence, some say the FDA really stands for the Foot Dragging Administration or the Foolishly Doesn't Act agency.
In case you are wondering, the drug in question is piroxicam (Feldene). The drug is used as a painkiller and an anti-inflammatory for arthritis and other conditions. Its dangers were exposed in 1994, when the Health Research Group (HRG), publishers of Worst Pills, Best Pills (it puts out the newsletter and book with that name) told the FDA to ban piroxicam because of its unique gastrointestinal toxicity and the absence of any evidence of a unique benefit.
HRG cited a study that found that in comparison to ibuprofen (Advil, Motrin), "piroxicam was between 2.8 and 7.1 times more likely to be associated with severe gastrointestinal toxicity, defined as bleeding, ulceration or perforation. No other NSAID [nonsteroidal anti-inflammatory drug] was as consistently as high in gastrointestinal risk as piroxicam."
In addition, HRG noted that through mid-1994, there were 144 cases reported to the FDA of deaths of patients from serious gastrointestinal side effects. Almost 90 percent of those cases were patients over the age of 60.
The FDA turned down the petition. Now all of these NSAIDs carry the same warning, giving the false impression that they all carry the same gastrointestinal risks. This false FDA labeling is contrary to the studies and contrary to the position of the European Medicines Agency and the warning it issued to the 27 European Union countries.
The prescribing trends for piroxicam carry important messages as to prescribing practices. In 1984, there were 8 million prescriptions filled for piroxicam. As physicians and patients learned of the dangers of this drug, the number of prescriptions dropped to 5.5 million prescriptions in 1992 and fewer than 1 million in 2002. However, the dangers of piroxicam are now apparently being forgotten by patients and doctors as the number of prescriptions written has more than doubled since 2002, coming in at over 2 million in 2006.
What can you do if you are taking this drug? First you should be aware of the warnings from the European Medicines Agency that it should "no longer be used for treatment of short-term painful and inflammatory conditions" and should not be the first choice for "symptomatic relief of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis [a form of arthritis that particularly affects the spine]."
Worst Pills, Best Pills News (November 2007) has some further advice. If you are taking piroxicam, ask your doctor if another one of the NSAIDs might be substituted. They would include ibuprofen (Advil, Motrin) and naproxen (Aleve, Anaprox, Naprosyn). It also notes, "Naproxen has the added advantage of having the least cardiac risk of the currently used NSAIDs (both ibuprofen and naproxen are available over the counter)."