Pain Medications (cont.)
- Long-term use of NSAIDs can cause bleeding in the stomach. In response to this, the drug industry has produced a class of NSAIDs, the COX-2 Inhibitor.
- Presently, only celecoxib (Celebrex) remains on the market.
Valdecoxib (Bextra) and rofecoxib (Vioxx) were voluntarily withdrawn from the market because of an increased risk of heart attack, stroke, and severe skin toxicity
Because these medications have been on the market for
only a short time, the long-term side effects are just beginning to be
understood. These medications have not been proven to be stronger than
ibuprofen, acetaminophen, or naproxen. It is also unclear whether these
medications cause less significant stomach problems.
- People older than 75 years are at more risk of significant stomach problems, such as ulcers, from NSAIDs, especially if they have had previous ulcers. Elderly individuals also typically have higher risk factors for heart attack and stroke.
- Alert: On September 30, 2004, Merck & Co, Inc, announced a voluntary
withdrawal of the COX-2 inhibitor, rofecoxib (Vioxx), from the US and worldwide
market because of its association with an increased rate of
cardiovascular events (including heart attacks and strokes) compared to that
of placebo. A major
US Food and Drug Administration
(FDA) study of rofecoxib found an apparent 3-fold increase in the risk of sudden
cardiac death or heart attack among patients who had taken higher doses of the
drug compared to the risk of patients who had not recently received similar
medication. The report showed that even patients taking the standard starting
dose of 12.5 mg or 25 mg of rofecoxib had a 50% greater chance of heart attack
or sudden cardiac death than patients on any dose of celecoxib (Celebrex). The
large-scale study was conducted after analyzing the medical records of 1.4
million people insured by Kaiser Permanente in Oakland, Calif, between
- Alert: On April 7, 2005, valdecoxib (Bextra, by Pfizer, Inc) was
voluntarily withdrawn from the US market, pending further discussion with the
FDA. The association of valdecoxib with potentially life-threatening risks,
including myocardial infarction, stroke, and serious skin reactions, initiated
an investigation to determine whether the benefits of the drug outweighed the
risks. The serious skin reactions are most likely to occur in the first
two weeks of treatment, but they can occur at any time during therapy.
Other COX-2 inhibitors and traditional NSAIDs (for
example, naproxen [Aleve, Naprosyn], ibuprofen [Motrin]) also have a risk for
these rare, serious skin reactions, but the reported rate of the reaction
appears to be greater for valdecoxib. Data regarding risks in individuals
who take valdecoxib following heart bypass surgery showed an
increased risk of heart attack, stroke,
deep vein thrombosis (blood
clots in the leg), and pulmonary
embolism (blood clots in the lungs).
- Celecoxib (Celebrex) remains on the market and appears to have the same cardiac risk profile as does ibuprofen.
Besides COX-2 inhibitors, other options exist to protect the stomach from ulcers and bleeding associated with NSAIDs. The additional use of misoprostol
(Cytotec) or a proton pump inhibitor, such as omeprazole
(Prevacid), or esomeprazole
(Nexium), with an older NSAID may decrease ulcer formation and
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