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Bextra Information

Bextra information from Pfizer, Inc.
Drug manufacturer's website containing information on Bextra.

Information from the FDA on Bextra
From the FDA's Center for Drug Evaluation and Research

SEC Asks Pfizer for Bextra, Celebrex Data

August 9, 2005, Forbes
Pfizer Inc. is responding to a request from the Securities and Exchange Commission for information and documents on its Bextra and Celebrex painkillers, the drugmaker said Tuesday in a filing.

Behind Bextra's Fall

April 21, 2005, Forbes
The memo states emphatically--and up-front--that Vioxx, Bextra and Celebrex all appear to be linked to an increased risk of heart attack and stroke. .... It (Bextra) It was pulled because it also has a serious risk of potentially lethal skin reactions.

April 7, 2005: Pfizer Voluntarily Withdraws Bextra

On April 7th, 2005, the Food and Drug Administration (FDA) announced that it has asked Pfizer, Inc. to voluntarily withdraw Bextra (valdecoxib) from the U.S. market. Pfizer agreed to suspend sales and marketing of Bextra in the U.S., pending further discussions with the FDA.

Pfizer Withdraws Bextra from Market

April 7, 2005 - Citing concerns regarding the risk of heart attacks, strokes, "life threatening" skin reactions, and other cardiovascular events the FDA requested that drugmaker Pfizer withdraw Bextra from U.S. and European pharmaceutical markets.

"Today's actions protect and advance the health of the millions of Americans who rely on these drugs every day," said Dr. Steven K. Galson, acting director of FDA's Center for Drug Evaluation and Research.

The risks posed by Bextra outweigh its benefits, the FDA said.

"For now, patients should stop taking Bextra and contact their physicians about appropriate treatment options," Pfizer said in a statement Thursday.

If you or a loved one have suffered from the dangerous side effects of Bextra, you should consider receiving a “free legal consultation” from an experienced Bextra lawyer.

December 17, 2004, Reuters - Doctors writing in a prominent medical journal on Friday recommended that physicians stop prescribing Pfizer Inc.'s Bextra painkiller, just as a large study found the drug maker's sister drug, Celebrex, doubled risk of heart attacks.

Pfizer Inc. on Friday (Oct. 15, 2004) said two small clinical trials showed heart bypass surgery patients taking Bextra, an anti-inflammatory in the same class as the recently withdrawn drug Vioxx, had a higher risk of stroke and heart attack.

In light of the increased focus on alternative treatment options for people with arthritis, Pfizer plans to conduct further studies to confirm the long-term cardiovascular safety profile of its anti-inflammatory drug Bextra.

Bextra is approved to treat pain from arthritis and, like Merck & Co.'s Vioxx, is a COX-2 inhibitor. A recent trial showed Vioxx doubled the risk of heart attack and stroke in arthritis patients who took the drug for more than 18 months.

The Vioxx withdrawal has cast a cloud over the entire class of COX-2 inhibitors, which includes Bextra, Celebrex and an experimental drug from Novartis AG called Prexige.

Recent evidence suggests that Bextra increased risk of stroke and heart attack when it was given to very high-risk patients who had undergone coronary bypass surgery.

As it relates to arthritis, Bextra has only been studied in these patients for up to a year.

Doctors said it is too early to quantify the potential risk of Bextra or of Pfizer's other COX-2 inhibitor Celebrex as neither have tested for long enough. Pfizer said it is conducting longer term trials in arthritis patients.

Pfizer's research studied use of Dynastat and Bextra in patients who had just had coronary artery bypass graft.

In these studies, there was an increase in cardiovascular events.

The first study involved 450 patients, 300 of which received Bextra and Dynastat. All the patients had the option of giving themselves morphine and opiates and everyone received low-dose aspirin.

In that trial, there was a trend showing the Bextra-Dynastat combination was leading to higher adverse event rates, though it wasn't statistically significant.

So, Pfizer decided to run an additional larger study to confirm the results.

The second study involved three groups of 500 patients each. The first received a placebo meant to look like Dynastat, then a sugar pill meant to look like Bextra and then the standard narcotic pain drugs like morphine. The second group received an indictable placebo, Bextra and the standard pain drugs. The third group got both Dynastat, Bextra and the other drugs.

All groups received their drugs for 10 days following coronary bypass surgery.

In the first group with the two placebos, 3 people suffered severe coronary events, 6 people in the Bextra group had these events and 11 people in the Bextra and Dynastat group suffered them.

The coronary bypass trials are ones that Dr. Eric Topol of the Cleveland Clinic Foundation and an early and outspoken critic of Vioxx, said he finds concerning as they show a cluster of heart attacks and strokes.

Pfizer also said it is updating its label on Bextra to strengthen a warning about a rare but serious skin reaction, Stevens-Johnson syndrome, that can occur mainly within the first two weeks of therapy.

Preliminary test results show heart attack links to Bextra

Pfizer, the manufacturer of cox-2 inhibitor drug, Bextra, could face a fresh round of lawsuits following recent tests that indicate that there could well be a link between Bextra and an increased risk of heart attacks. The studies were carried following the recent recall of a similar drug, Vioxx, from the market due its links with increased heart attacks and strokes.

The New York Times recently reported that preliminary test results indicated that Bextra could have the same problem. The results of the tests were revealed on 9th November 2004 at a meeting of the American Heart Association in New Orleans. Dr. Garret A. FitzGerald, a cardiologist and pharmacologist at the University of Pennsylvania, said: "The magnitude of the signal with Bextra is even higher than what we saw in Vioxx. This is a time bomb waiting to go off."

The manufacturer of the drug, however, has stated that these test results are unsubstantiated, but has also stated that it will be carrying out investigations to assess whether there are any heart attack or stroke risks attached to Bextra. In addition to this, the FDA is looking into the effects of Bextra as well as other cox-2 inhibitors following the recent recall of Vioxx.

Do I have a Bextra Case?

If you believe that you or a loved one has been adversely affected by Bextra, please fill out the form below. There is no charge for this Bextra case evaluation.

Free Bextra Stevens Johnson Syndrome Case Evaluation

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Injured Person Information:

Date of Birth: mm 01 02 03 04 05 06 07 08 09 10 11 12 dd 01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 yyyy 2005 2004 2003 2002 2001 2000 1999 1998 1997 1996 1995 1994 1993 1992 1991 1990 1989 1988 1987 1986 1985 1984 1983 1982 1981 1980 1979 1978 1977 1976 1975 1974 1973 1972 1971 1970 1969 1968 1967 1966 1965 1964 1963 1962 1961 1960 1959 1958 1957 1956 1955 1954 1953 1952 1951 1950 1949 1948 1947 1946 1945 1944 1943 1942 1941 1940 1939 1938 1937 1936 1935 1934 1933 1932 1931 1930 1929 1928 1927 1926 1925 1924 1923 1922 1921 1920 1919 1918 1917 1916 1915 1914 1913 1912 1911 1910 1909 1908 1907 1906 1905 1904 1903 1902 1901 1900 Whom are you inquiring on behalf of? Minor Other Self If you are NOT inquiring on your own behalf, what is your relationship? Is the person deceased? Yes No If deceased, the cause of death as stated on the death certificate:  Date of Death: mm 01 02 03 04 05 06 07 08 09 10 11 12 dd 01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 yyyy 2005 2004 2003 2002 2001 2000 1999 1998 1997 1996 1995 1994 1993 1992 1991 1990 1989 1988 1987 1986 1985 1984 1983 1982 1981 1980 1979 1978 1977 1976 1975 1974 1973 1972 1971 1970 1969 1968 1967 1966 1965 1964 1963 1962 1961 1960 1959 1958 1957 1956 1955 1954 1953 1952 1951 1950 1949 1948 1947 1946 1945 1944 1943 1942 1941 1940 1939 1938 1937 1936 1935 1934 1933 1932 1931 1930 1929 1928 1927 1926 1925 1924 1923 1922 1921 1920 1919 1918 1917 1916 1915 1914 1913 1912 1911 1910 1909 1908 1907 1906 1905 1904 1903 1902 1901 1900 Was there an autopsy performed? Yes  No  n/a Did you take Bextra within 2 weeks of your injury? Yes  No

Case Information:

During what period of time was Bextra prescribed? Start End Why was Bextra prescribed? What dosage of Bextra were you prescribed daily? List names/addresses of any doctors who prescribed Bextra: Did effects from Bextra include: Stevens Johnson Syndrome Yes No Heart Attack Yes No Stroke Yes No Deep Vein Thrombosis Yes No Blood Clots Yes No Pulmonary Embolism Yes No Death Yes No Other medical problems since Bextra usage: Date medical problem(s) first occurred: Other Information:

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