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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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Have had ulcers or stomach
bleeding have had asthma, hives, or allergic-type reactions after taking aspirin
or other NSAIDs have severe kidney problems have severe liver problems are
pregnant General Precautions with Vioxx:
Do not stop taking any medications that you have been prescribed without first
talking to your doctor.
Why let pain force you to put the
things you enjoy most on hold?
One tablet of VIOXX, once a day, can provide 24-hour relief of osteoarthritis
symptoms to help you do the things you enjoy.
Only your healthcare provider can decide if VIOXX is right for you.
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.
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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.
Serious problems such as liver
damage have occurred in people treated with NSAIDs.
Some of the warning signs of liver damage can be nausea, vomiting, fatigue, loss
of appetite, itching, yellow coloring of skin or eyes, "flu-like" symptoms and
dark urine.
If you experience any of these symptoms, call your health care provider right
away.
(This is NOT a complete list of
side effects reported with Vioxx. Your health care provider can discuss with you
a more complete list of side effects.)
VIOXX -
Part 10
Important Information:
What are some possible side effects of Vioxx?
Side effects can include:
Upper respiratory tract infection Diarrhea Nausea Heartburn Swelling of the
lower legs or feet High blood pressure Rarely, serious ulcers have occurred in
patients taking Vioxx.
For more detailed information about Vioxx, ask your health care provider.
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