The consequences for patients takingthe drug
The withdrawal of Rofecoxib, marketed as Vioxx by the pharmaceutical company Merck & Co Inc., will affect a significant number of Irish patients.
Rofecoxib is one of the latest generation of non-steroidal anti-inflammatory drugs (NSAIDS). Called Cox-2 inhibitors, because they block the action of the enzyme cyclooxygenase and inhibit joint inflammation, they are licensed for use by people with osteoarthritis - "wear and tear" arthritis - and rheumatoid arthritis, the most serious form of joint disease. The drug was first marketed in the Republic early in 2000.
Cox-2 inhibitors were introduced as an improvement on the first generation of NSAIDS. Research suggested they were effective in reducing joint inflammation and pain. They are also marketed as being less likely to cause gastrointestinal problems.
The most serious potential side effect of all NSAIDS is the risk of causing bleeding in the stomach. Despite their improved profile in this regard, Cox-2 inhibitors are contraindicated in patients with a history of peptic ulcer disease.
NSAIDS are also known to worsen heart failure. The prescribing information for Rofecoxib specifically states it must not be used in patients with established congestive cardiac failure, or heart failure.
Yesterday's alert that Rofecoxib caused stroke and other vascular events was unexpected. Coronory heart disease is listed as a relative side effect on the prescribing and patient data sheets. The high incidence of heart attacks reported in the trial may be related to this.
Rofecoxib, which is prescribed in 12.5 mg and 25 mg tablets, has been taken off the market. What should you do if you are currently taking this drug? First of all, do not stop it precipitously. To do so would risk a flare up of your arthritis.
However, you should visit your family doctor within the next week to discuss an alternative treatment. You may be offered a different Cox-2 inhibitor or your doctor may recommend one of the older NSAIDS.
Some older users of Rofecoxib may not be entirely sure of their medication details. If you have an older relative or friend, you should consider bringing this issue to their attention and perhaps checking their medication with them.
According to the Irish Medicines Board, the safety aspects of all Cox-2 inhibitors will be discussed at a meeting of European drug regulatory agencies next week.