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The most important step for patients currently taking Vioxx or Celebrex is to discuss their health and history with their physician. Your doctor is hopefully aware of the potential health risks associated with these Cox-2 inhibitors and may advise using low-dose aspirin or some other alternative in order to minimize the risk of heart disease from these drugs. Patients must educate themselves on the potential risks, and if they experience any side effects associated with Cox-2 inhibitors, they need to immediately contact their doctor.
FDA: Too early to draw conclusions about Celebrex safety. Five of the 10 people who died suffered from gastrointestinal bleeding or ulcers. Of the other deaths, two were attributed to heart attacks, one to drug interaction, one to a kidney disorder--and a fifth cause remains undetermined.
"It's too early to reach any conclusions about the drug's safety," an FDA spokesman tells CNN.
The deaths and complications figured in the FDA's adverse-events report, which is filed quarterly. Reports of problems are provided by pharmaceutical companies, doctors and patients.
"There is no indication these deaths and complications were caused by the use of Celebrex," says Scarlett Foster, a spokesperson for Searle & Co., a subsidiary of Monsanto Company. "Before coming to any conclusions, we need to look at other medical conditions that could have contributed to these events."
Patient information materials provided by Searle & Co. also state stomach ulcers can occur in patients using Celebrex without the problem being evident. So patients and their doctors should watch for signs and symptoms of stomach bleeding.
Celebrex and Vioxx were approved for the U.S. market back in 1999 for the treatment of arthritis and other types of pain. Both of the drugs constituted a new class of drugs called Cox-2 inhibitors. Their release seemed to be cause for celebration for individuals who had previously taken aspirin or other NSAIDs (nonsteroidal anti-inflammatory drugs), but were bothered by gastrointestinal problems commonly associated with them.
Celebrex and Vioxx were touted as great medical developments in the many ads that promoted their benefits. Principal among these was the claim that Vioxx and Celebrex relieved pain without causing stomach problems. Specifically, these Cox-2 inhibitors are prescribed to relieve symptoms commonly associated with osteoarthritis, menstrual cramps, or other acute pain. Unfortunately, Vioxx and Celebrex pose troubling effects for some users.
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Questions you should ask yourself when writing in the OA Pain Diary include:
What does your pain feel like? (Pain can be difficult to describe. Do your best to put it into words, such as “throbbing,” “aching,” or “stabbing.”)
When did your pain first begin, and in what part of your body?
Has it spread to other areas? Have you experienced any swelling, stiffness, or other symptoms?
Is your pain worse at certain times of the day or after certain activities?
Has anyone in your family had similar problems?
In clinical studies lasting up to
21 months, osteoarthritis patients taking 1 small tablet of VIOXX reported a
significant reduction in arthritis pain. Once-daily VIOXX continued to provide
relief from pain for the length of the studies.
So VIOXX can help make it easier for you to do the things you want to do—like
sitting down on the grass to watch your kid’s soccer game—with all-day and
all-night relief.
These problems can happen without
any warning, but in some people may cause symptoms such as gnawing or burning
stomach pain, black or tarry stools, or vomiting.
If this happens, stop taking Vioxx and call your health care provider right
away.
Check with your health care provider.
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Partnering With Your Doctor
Actively partnering with your doctor allows you to manage your osteoarthritis pain and helps your doctor make better-informed decisions about your treatment.
In this section we offer our OA Pain Diary to help you keep track of your pain episodes.
Use it to monitor your arthritis pain so both you and your doctor can get an accurate picture of any recurring patterns, changes, or new developments.
Even if your condition doesn’t change for several days, you should still note it in the diary.
In clinical studies lasting up to
21 months, osteoarthritis patients taking 1 small tablet of VIOXX reported a
significant reduction in arthritis pain. Once-daily VIOXX continued to provide
relief from pain for the length of the studies.
So VIOXX can help make it easier for you to do the things you want to do—like
sitting down on the grass to watch your kid’s soccer game—with all-day and
all-night relief.
If you have asthma, you may have
aspirin-sensitive asthma.
If an aspirin-sensitive asthmatic takes aspirin it can cause severe narrowing of
the airway (bronchospasm), and even death.
Since this type of reaction to aspirin and other NSAIDs have occurred in
aspirin-sensitive patients, Vioxx should not be given to aspirin-sensitive
patients.
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