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arthritis and relieve pain, was withdrawn from the market by its maker, Merck.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
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
MedicineNet.com recently surveyed online viewers after the
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
- Now, more than ever, it is important for doctors and
patients to communicate with each other. Our MedicineNet.com 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.
- 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
- 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.
- 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
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.
Last Editorial Review: 4/7/2005
- 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.