Cox-2 Inhibitors Dilemma: What Patients Should Do (cont.)

What Happened With Vioxx (rofecoxib)?

On September 30, 2004, Vioxx (rofecoxib), a drug used to quiet the inflammation of arthritis and relieve pain, was withdrawn from the market by its maker, Merck. The reason for the withdrawal was the occurrence of side effects noted in a study that Merck was conducting to see if Vioxx could prevent polyps of the colon and rectum. During this trial, it was noted that there was an increased risk for heart attack and stroke in patients continuing to take Vioxx longer than 18 months.

The risk of heart attack or stroke from taking Vioxx was small, but real. Of note, there has been no indication that any long term damage occurs once the drug is discontinued.

Problems After Vioxx Withdrawal

A natural concern about the potential side effects of other inflammation medications of the same class as Vioxx has arisen. This class (the COX-2 inhibitors) includes Celebrex and Bextra, also popular medications used to stop pain and inflammation.

Currently, there are some reports suggesting that these medications do not increase the risk of heart attack or stroke and a few reports suggesting that they can. There are also media reports and letters in some high profile medical journals suggesting that patients should not be taking some or all COX-2 inhibitors, while ads on television by plaintiff's attorneys only further the agitation. recently surveyed online viewers after the Vioxx drug withdrawal and found that over half of former Vioxx users did not contact their physicians before stopping the medication or shifting to an alternative medication over-the-counter! Moreover, a majority of former Vioxx users expressed "worry" about potential side effects of all medications. Well over half of these viewers experienced side effects from new medications they ended up using, while less than half benefited from the new medication! Click here to read the results of the survey.

What Should Patients Do?

The upcoming (mid February, 2005) FDA hearing on the COX-2 inhibitors may or may not resolve some of the concerns described above. Meanwhile, as doctors and patients, we move on. Below are some methods I suggest as appropriate for patients encountering decisions regarding medications. They are principles that I use as a practicing arthritis specialist in dealing with my patients day to day.

  1. Now, more than ever, it is important for doctors and patients to communicate with each other. Our survey indicates that the media is having a substantial impact on medication decision-making. Patients should absolutely not be directing their medication usage based on media comments without contacting their doctors. This practice can lead to dangerous complications. Doctors must listen carefully to their patients' concerns about safety and review the performance of the prescribed medications in response to the Vioxx withdrawal.
  1. Patients with chronic pain rely on their pain medication for relief of their symptoms and to improve their quality of life. They should only be taking medications that are truly needed to treat specific conditions for which the medications are used. Should the patients' conditions improve or resolve, then it may or not be the case that their medications could be reduced or discontinued.
  1. Medications should be used in the lowest dose that is effective for the condition treated. Lower doses of medications are nearly always somewhat safer. However, they are not always optimal. For example, lower doses of NSAIDs (nonsteroidal anti-inflammatory drugs) might be used for degenerative arthritis (osteoarthritis) than for inflammatory forms of arthritis (such as rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis), which typically require high doses of anti-inflammatory medication for adequate treatment.
  1. The risks and benefits of taking a medication must be evaluated in an individualized fashion for each patient. The decision to take a medication requires knowledge of the severity of the condition treated, underlying medical conditions, past medication experiences, and the patient's age to adequately appreciate the risks. Likewise, when a patient considers discontinuing a medication, his or her chart needs to be reviewed by a doctor to consider several factors. Why was the patient taking this particular drug? Were there side effects or allergies? How would a substitute drug help the underlying condition and interact with other drugs the patient may be taking. There is no universal substitute for any particular drug. Rather, each patient requires a personal evaluation in considering an alternative medication.
  1. Finally, controversial research by medical scientists should not be allowed to create unnecessary anxiety for patients who are not communicating with their doctors. Patients' concerns should be minimized by consulting with their doctors, who are in the best position to discuss these issues within the context of their individual case. Similarly, doctors' who have concerns based on new medical knowledge should discuss them openly with their patients.

Last Editorial Review: 4/7/2005