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Study Links Pfizer's Bextra, Similar to Vioxx, to Heart Attacks
Study Links Pfizer's Bextra, Similar to Vioxx, to Heart Attacks -- Posted by MrPepper11 on 11-09-04 22:25
New York Times
November 10, 2004
New Study Links Pfizer's Bextra, Similar to Vioxx, to Heart Attacks
By GARDINER HARRIS
The incidence of heart attacks and strokes among patients given
Pfizer's painkiller Bextra was more than double that of those given
placebos, according to preliminary results of a study presented
yesterday at the American Heart Association meeting in New Orleans.
The study, which pooled data from 5,930 patients taking part in 12
trials, found 2.19 times the number of heart attacks or strokes among
patients given Bextra, compared with those given placebos. Merck
recently withdrew Vioxx, a drug similar to Bextra, after a longer and
better-controlled study showed that it doubled the risk of heart
attack and stroke.
"The magnitude of the signal with Bextra is even higher than what we
saw in Vioxx," Dr. Garret A. FitzGerald, a cardiologist and
pharmacologist at the University of Pennsylvania, said in an interview
after presenting the data. "This is a time bomb waiting to go off."
Susan Bro, a spokeswoman for Pfizer, said that a heart problem with
Bextra appeared only in studies involving patients at very high risk
for heart disease who were undergoing cardiac surgery - a disclosure
Pfizer made on Oct. 15. Other studies of Bextra involving 8,000
patients with arthritis who were followed for 6 to 52 weeks found no
heart problems, she said.
Dr. FitzGerald is one of the world's leading experts in COX-2 drugs, a
class of medicine that includes Vioxx, Bextra and Celebrex, which is
also made by Pfizer. Vioxx had sales of $2.5 billion last year, while
Celebrex had sales of $1.8 billion and Bextra $687 million. Celebrex
and Bextra have been on their way to bigger sales this year.
In previous studies, Dr. FitzGerald was among the first to explain why
COX-2 inhibitor drugs, which were developed to cure pain without
causing ulcers, might create heart troubles.
Dr. Curt Furberg, professor of public health sciences at Wake Forest
University School of Medicine, helped conduct the study that Dr.
FitzGerald announced yesterday. "Basically, we showed that Bextra is
no different than Vioxx, and Pfizer is trying to suppress that
information," Dr. Furberg said.
The new study of Bextra, however, is not nearly as persuasive as the
trial that led to Vioxx's withdrawal because it is backward-looking
and simply reorganizes data presented in other settings. Ms. Bro, the
Pfizer spokeswoman, said the new study grouped samples that were too
disparate for conclusive results.
But Dr. FitzGerald said the latest findings added to growing worries
that all COX-2 inhibitors, including Bextra and Celebrex, should be
used with great caution.
There is no evidence that Celebrex causes heart problems, Pfizer said.
The FitzGerald study was not the only negative development regarding
Bextra. News reports yesterday noted that Pfizer said in a Nov. 5
regulatory filing that the Food and Drug Administration had rejected
an application to use Bextra to treat migraines. The company said it
was notified in August of the rejection.
Pfizer's stock slipped 25 cents yesterday to close at $25.99. It
declined 38 cents on Monday, as investors digested the company's
disclosure that it would probably add a "black box" warning - the
strongest kind - to Bextra's label. The warning would note that, in
rare instances, the drug could cause fatal skin rashes. In its Oct. 15
warning about Bextra's potential risks to patients after heart
surgery, Pfizer acknowledged that it had known the results of this
study for at least two months before announcing them. During that
period, Pfizer representatives said publicly that the company had no
evidence that either Celebrex or Bextra caused the kind of heart
problems found in a large study of Vioxx.
Bextra is approved to treat arthritis pain. Unlike Vioxx, neither
Bextra nor Celebrex has proved to be any safer on the stomach than
older, cheaper medicines like ibuprofen or naproxen. Nor has Bextra or
Celebrex been shown to alleviate pain any better than those older
drugs.
As the COX-2 controversy has continued, the Food and Drug
Administration has been criticized by some researchers and medical
journal editors for failing to require Vioxx's withdrawal years ago.
Yesterday, Health and Human Services Secretary Tommy G. Thompson
defended the F.D.A.'s handling of the Vioxx withdrawal.
"You can always be a Monday morning quarterback and say, you know,
this could have been done better," Mr. Thompson said. "I think the
F.D.A. just does an outstanding job of protecting Americans' health."
Vioxx's maker, Merck, suffered a financial blow yesterday, as the
rating on its $4.9 billion in long-term debt was cut two levels, to
Aa2 from Aaa, by Moody's Investors Service. The company's share price
has plummeted after the withdrawal of Vioxx, which accounted for 11
percent of the company's sales last year. Hundreds of lawsuits have
been filed by lawyers for patients or their survivors claiming Vioxx
caused injuries or deaths.
On Tuesday, Dr. FitzGerald also provided results of his further
investigations into the mechanism by which COX-2 medicines may lead to
heart troubles. Using mice, Dr. FitzGerald said, he found that
inhibiting the COX-2 enzyme might reduce the heart protection of
estrogen.
Re: Study Links Pfizer's Bextra, Similar to Vioxx, to Heart Attacks -- Posted by Wayne Alan Simon on 11-09-04 22:45
I was on bextra last year for one week, in that week my blood pressure went
up, (was never high before), and on day say I broke out in a total body
rash, which was biopsied and blamed on bextra, the only medication I was
taking. After going off bextra and going back to ibuprofen, my blood
pressure returned to normal, and I get no skin reaction from the routine
NSAIDS. I do not know at this time what the FDA is going to do with the
drugs in this class that remain on the market
Re: Study Links Pfizer's Bextra, Similar to Vioxx, to Heart Attacks -- Posted by Harvey R. Stone on 11-10-04 03:01
Thanks for telling us your reaction to Bextra.
harv
"Wayne Alan Simon" wrote in message
news:KGikd.61790$Tq1.2979@bignews1.bellsouth.net...
>I was on bextra last year for one week, in that week my blood pressure went
> up, (was never high before), and on day say I broke out in a total body
> rash, which was biopsied and blamed on bextra, the only medication I was
> taking. After going off bextra and going back to ibuprofen, my blood
> pressure returned to normal, and I get no skin reaction from the routine
> NSAIDS. I do not know at this time what the FDA is going to do with the
> drugs in this class that remain on the market
>
>
Re: Study Links Pfizer's Bextra, Similar to Vioxx, to Heart Attacks -- Posted by Katherine Wolfe on 11-10-04 14:48
"MrPepper11" wrote in message
news:57cfd534.0411092225.4a2e40bd@posting.google.com...
>
> "The magnitude of the signal with Bextra is even higher than what we
> saw in Vioxx," Dr. Garret A. FitzGerald, a cardiologist and
> pharmacologist at the University of Pennsylvania, said in an interview
> after presenting the data. "This is a time bomb waiting to go off."
>
> Dr. FitzGerald is one of the world's leading experts in COX-2 drugs, a
> class of medicine that includes Vioxx, Bextra and Celebrex, which is
> also made by Pfizer. Vioxx had sales of $2.5 billion last year, while
> Celebrex had sales of $1.8 billion and Bextra $687 million. Celebrex
> and Bextra have been on their way to bigger sales this year.
I'm wondering, if it comes to light that people at Merck and Pfizer knew of
their drug's potential to cause cardiac problems, are they criminally
liable? I'm not sure exactly what would deter a company from marketing
drugs with dangerous side effects like Vioxx, once the cap on damages gets
put into law.
Katherine
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