Drug Profile

Do Not Use: This drug is no more effective than related drugs and causes a higher rate of ulcers and skin reactions.

Piroxicam (FELDENE) belongs to the family of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs), often used to treat arthritis in older adults.

Piroxicam relieves pain and inflammation caused by two kinds of arthritis: rheumatoid arthritis and osteoarthritis. It can cause serious adverse effects and has caused numerous deaths, especially in older adults.[1],[2] Expert analysis of the drug indicated that piroxicam is inappropriate for use in older adults because of its toxicity.[3]

Adverse effects

NSAIDs can cause serious harm, even death, from bleeding in the stomach or intestines. Bleeding can occur at any time and without warning, and older people are more likely to experience adverse effects from bleeding. People over age 60 are more likely than other users of this drug to suffer stomach and intestinal bleeding, ulcers and perforations. These adverse effects have occurred even when patients were taking only the recommended dose. Older adults also are more likely to have reduced liver and kidney function. Some doctors believe people over age 70 should be started with half the usual dose of drugs in this group.[4] People in all age groups have had serious skin reactions, some of which have been fatal, while taking piroxicam.

The British Medical Journal (BMJ) published a meta-analysis (a study that combines data from many other studies) examining the use of NSAIDs and cardiovascular safety. The authors of the article stated that there is a risk of cardiovascular adverse effects associated with these drugs, and this risk must be considered when treating patients.

Information from another article in the BMJ found that the use of NSAIDs was associated with the occurrence of abnormal heart rhythms called atrial fibrillation or flutter.[5]

NSAIDs rarely can cause serious adverse skin reactions such as Stevens-Johnson Syndrome and toxic epidermal necrolysis, which can be fatal.[6]

There have been reports of patients taking NSAIDs developing a potentially fatal disorder known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS can lead to fever; rash; swollen lymph glands; and inflammation in the liver, kidneys, heart and other organs.[6]

Interactions

Studies suggest a possible harmful interaction between NSAIDs and a class of osteoporosis drugs called bisphosphonates. Patients need to be alert to the fact that the combination can result in an increased risk of ulcers and other gastrointestinal adverse effects. Read more in the July 2010 issue of Worst Pills, Best Pills News.

Combining NSAIDs with anticoagulants (blood thinners for preventing blood clots) increases the risk of serious bleeding complications.[7]

When not to use NSAIDs

Treatment with NSAIDs is not recommended in patients with advanced kidney disease. However, if NSAID therapy must be initiated, close monitoring of the patient’s kidney function is advisable.

NSAIDs also should not be used by patients in whom aspirin or other nonsteroidal anti-inflammatory/analgesic drugs induce the symptoms of asthma, rhinitis and nasal polyps. These reactions have the potential to be fatal. Therefore, it is important for patients with asthma, nasal polyps, hives and/or low blood pressure associated with NSAIDs to make their doctors aware of these conditions before starting therapy. In addition, if such symptoms occur during therapy, treatment should be discontinued.

Better options available

Among the NSAIDs, evidence shows that ibuprofen (ADVIL, MEDIPREN, MOTRIN, NUPRIN) is less toxic than other drugs in this family to the gastrointestinal tract, which is one of the main safety concerns with NSAIDs.[8],[9],[10],[11],[12]

However, aspirin (EASPRIN, ECOTRIN, EMPIRIN, GENUINE BAYER ASPIRIN) is just as effective as and less costly than other NSAIDs and is the drug of choice for treating pain, fever and inflammation in people who do not have ulcers, gastritis (inflammation of the stomach) or an allergy to aspirin. Some rheumatologists still prefer aspirin to other NSAIDs for treating rheumatoid arthritis.[13]

Regulatory actions surrounding piroxicam

1994: Public Citizen’s Health Research Group unsuccessfully petitioned the Food and Drug Administration (FDA) to remove piroxicam from the market because of its gastrointestinal toxicity.[14]

2005: The FDA requested that manufacturers of NSAIDs, both prescription and over-the-counter, revise the drugs’ labels to include the potentially increased risks of cardiovascular events (read the information noted with COX-2 inhibitors) and gastrointestinal bleeding (see “Warnings” box at top of page). The FDA also required a Medication Guide be provided to patients with each dispensed prescription.

2007: In June, the European Medicines Agency recommended restrictions on the use of piroxicam because of gastrointestinal adverse effects and serious skin reactions. The agency recommended that piroxicam no longer be used for short-term pain and inflammation and that it not be used as a first-line treatment.[15]

2009: Health Canada, an agency similar to the FDA, advised health care professionals in Canada that piroxicam should not be used to treat short-term pain and inflammation due to an increased risk of skin reactions and gastrointestinal problems. This advisory was based on information showing that when piroxicam was compared to similar drugs, the risks outweighed the benefits.[16]

2015: The FDA announced that the agency is strengthening the existing warning for all non-aspirin NSAIDs concerning an increased risk of heart attack and stroke.[17]

2020: The FDA and Health Canada (an agency in Canada similar to the FDA) warned that use of NSAIDs at about 20 weeks or later in pregnancy rarely causes serious kidney problems in an unborn baby.[18],[19] These kidney problems can lead to oligohydramnios, a condition in which there are low levels of amniotic fluid surrounding the baby. Amniotic fluid normally provides a protective cushion and plays an important role in the development of a baby’s lungs, digestive system and muscles. Oligohydramnios in turn can lead to decreased range of motion in a baby’s arms and legs and delayed lung maturation.