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Arthritis drug Vioxx recalled
CBC News -
NEW YORK - The arthritis drug Vioxx is being pulled from the market worldwide because new research data shows it could increase the risk of heart attacks and strokes, its manufacturer announced Thursday, September 30, 2004.

A study of people enrolled in the Kaiser Permanente health plan reportedly found that heart attack rates and sudden cardiac deaths were tripled in patients taking Vioxx in doses higher than 25 milligrams a day compared to those taking a competing drug, Celebrex.

The study was done by personnel at the FDA, who said that "this and other studies cast serious doubt on the safety" of Vioxx and that Celebrex "may be safer."

There’s So Much More to Life Than Osteoarthritis Pain

If osteoarthritis pain keeps you from the activities you enjoy most, there are things you can do about it. This site is designed to help you learn about managing your pain—and to tell you about VIOXX, and CELEBREX, prescription medicine that can provide relief for osteoarthritis, the most common type of arthritis.

Spend a few minutes looking through the information provided, then discuss it with your doctor. Information about your osteoarthritis, combined with a medicine like VIOXX or CELEBREX can help make it easier to do the things you want to do.



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What to do if you are currently taking Vioxx or Celebrex?

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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VIOXX  

Important Information About VIOXX

Tell your doctor if you have liver or kidney disease, or a history of angina, heart attack, or a blocked artery in your heart.

VIOXX cannot take the place of aspirin for prevention of heart attack or stroke.

VIOXX should not be used by women in late pregnancy.

Talk to your doctor to learn more about VIOXX.

VIOXX -  Part 10

Important Information:  What are some possible side effects of Vioxx?

(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.)

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.

VIOXX:  Important Information:  Part 4

Vioxx may not be right for you, if you:

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.

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Featured Vioxx Celebrex Articles

VIOXX -  Part 2

Osteoarthritis Pain

VIOXX Can Provide 24-Hour Relief of Osteoarthritis Pain to Help You Enjoy Everyday Things Again

Managing pain isn’t about being able to climb Mount Everest or run a marathon.

It’s about controlling the pain that keeps you from doing simple things, like taking a walk or bending down to build sand castles with your child.

VIOXX - PART 1

Important Information:  What is Vioxx used for?

Vioxx is used to relieve:

Signs and symptoms of osteoarthritis Acute pain in adults Painful menstrual cycles.

Who should not take Vioxx?

You should not take Vioxx if you have experienced asthma, hives, or allergic-type reactions after taking aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs).

A few examples of other NSAIDs are ibuprofen, naproxen, diclofenac, nabumetone, and ketoprofen.


VIOXX  - PART 1

Keeping Track of Your Pain

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?


 

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