VIOXX.
Do not panic about Vioxx.
Vioxx, a very common pain reliever and anti-inflammatory drug, was voluntarily
pulled from the market last week following the release of surprising medical
news. Often used for the treatment of osteoarthritis, rheumatoid arthritis, and
certain pain conditions, Vioxx is a drug within the class of COX-2 inhibitors.
Merck Pharmaceuticals, the manufacturer of Vioxx, generated this action despite
$2.5 billion in annual sales and more than 2 million patients currently using
this medication. So what does this decision mean for patients using Vioxx? Let's
take a closer look.
Why was this drug removed? A recent study looked at
the effects of Vioxx versus a placebo (sugar pill) on the development of recurrent
colon polyps. Colon polyps
are small growths of tissue within the colon that can be cancerous. Over the
years, it has been shown that aspirin has decreased the incidence on colon cancer
and polyps. Since aspirin and Vioxx are very similar types of drugs, it was thought
that Vioxx might decrease the incidence of re-developing colon polyps.
The study looked at a couple of questions. One being the effects on colon cancer
and the other looking at long-term safety. For the first 18 months of the study,
there were no concerns about long-term usage. But, it was noted that after 18
months, the risk of heart attack and stroke nearly doubled in those folks taking
Vioxx.
Now, in looking at the chance of a heart attack or stroke in these patients over
that time period, it is thought that the risk is .75%. In the Vioxx group, the
risk of heart attack or stroke was about 1.5% over that same time period, which
was about three years into the study.
Overall, Merck is being very cautious in dealing with this information and concern
of safety for patients. Many physicians have felt that this recall was somewhat
of an over-reaction. Of interest, numerous law firms have set up websites seeking
patients who feel that they have been injured from the use of this drug.
What is a COX-2 inhibitor? The process of pain and
inflammation is directed by a body chemical called cyclooxygenase, which occurs
in two forms, 1 and 2. Over
the years, health care providers have prescribed non-steroidal anti-inflammatory
drugs (NSAIDS) like ibuprofen and naprosyn to treat pain and inflammation. The
problem with these drugs is the side effects of developing stomach ulcers leading
to bleeding. They also can contribute to changes in the blood and cause kidney
failure. Even though they can be purchased over-the-counter, they must be used
with caution.
The Cox-2 inhibitors were developed as more specific drugs that had less chances
of developing bleeding in the gastrointestinal system. There have been three
on the market known as Vioxx, Celebrex, and Bextra, which are their trade names.
All three medications have been successful in treating pain from arthritis. The
benefit has been a decreased chance of developing a stomach ulcer. Several medical
studies have supported this claim.
Why take a COX-2 inhibitor? For patients affected with various
types of arthritis and pain conditions, it is essential that their pain be managed
daily with minimal
side effects. The decreased chance of side effects not only includes the risk
of bleeding. It has been shown that these drugs have provided good pain control,
fewer effects on the blood such as platelets, ability to take with Coumadin,
and less chance of worsening asthma conditions. It is well known that aspirin-like
drugs can worsen asthma
.
What should I do? If you are taking Vioxx, you must
contact your health care provider to discuss your options. The chance of side
effects noted in the study
with Vioxx were small, so do not panic! Your clinician will determine if you
need a switch to Celebrex, Bextra, or another similar medication. You will not
be able to refill your Vioxx, so you must seek medical advice. There is no risk
to suddenly discontinuing Vioxx.
As you wait to see your provider, you can access additional information at www.merck.com, www.vioxx.com,
or by calling 888.36VIOXX.
