Affecting the heart

[Yaps]

The arthritis drug Vioxx may not be the only drug of its type that raises the risk of heart attack and stroke, scientists suggest in a report released Wednesday by the New England Journal of Medicine.

That's contrary to what federal regulators said when the blockbuster pain reliever was pulled from the market last week.

Studies done five years ago when Pfizer's Celebrex and Merck & Co.'s Vioxx were approved suggest that the same mechanism that inhibits inflammation and makes the drugs easier on the stomach than traditional painkillers also blocks a substance that prevents heart problems, according to Dr. Garret FitzGerald, a University of Pennsylvania cardiologist who led the studies, which were designed by him but funded by the drug companies.

"I believe this is a class effect," meaning that the problem also applies to Celebrex and Pfizer's newer, similar drug, Bextra, which remain on the market.

He called on the federal Food and Drug Administration to change its advice to patients and doctors to reflect the new safety concerns. In a separate report also released by the medical journal, Dr. Eric Topol of the Cleveland Clinic chastises the FDA for not requiring Merck to do studies investigating heart problems with Vioxx when hints of them first appeared years ago.

Pfizer and FDA officials did not immediately return phone calls seeking comment.

When Merck voluntarily withdrew Vioxx, FDA officials said heart problems were unique to that drug and that the mechanism underlying them wasn't known.

But FitzGerald and colleagues published two studies in 1999 and another in 2001 suggesting that by selectively blocking one of the two substances called prostaglandins that lead to inflammation, these so-called cox-2 inhibitors were sparing the stomach at the expense of the heart.

"There's a good prostaglandin and a bad prostaglandin as far as the heart is concerned," he explained.

Suppressing both, as older painkillers like aspirin and other non-steroidal anti-inflammatory drugs, or NSAIDS do, helps the heart. But shutting down just the "good" one raises the risk of high blood pressure, hardening of the arteries and clotting, he reports.

The studies will be published in the Oct. 21 print edition of the medical journal.

 

[Harrybaby666]

I hope to God they find a suitable substitute for Vioxx

I hope to God they find a suitable substitute for Vioxx

Hi Yaps,

As one who is dealing with arthritis, I do so hope that they find a suitable substitute for Vioxx, as I know how the pain is/and can get. I just hope they do it before people really begin to suffer....

 

[Phyllis]

"Experts Raise Questions About Vioxx Decision

30 minutes ago

By Maggie Fox, Health and Science Correspondent

WASHINGTON (Reuters) - Two leading heart experts called for urgent investigations on Wednesday into whether all painkilling drugs known as COX-2 inhibitors may raise the risk of heart attack in some people.

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They also called for a Congressional investigation into whether regulators acted too timidly in last month's recall of Vioxx, Merck's best-selling COX-2 inhibitor.


Merck recalled the drug, ironically developed to be a safer alternative to aspirin and similar drugs such as ibuprofen, after learning it more than tripled the number of heart attacks in patients taking it in one study.


"I believe that there should be a full Congressional review of this case," Dr. Eric Topol of the Cleveland Clinic in Ohio wrote in a commentary in this week's New England Journal of Medicine (news - web sites).


"The senior executives at Merck and the leadership at the Food and Drug Administration (news - web sites) share responsibility for not having taken appropriate action and not recognizing that they are accountable for the public health," Topol added.


"Sadly, it is clear to me that Merck's commercial interest in rofecoxib (Vioxx) sales exceeded its concern about the drug's potential cardiovascular toxicity."


The FDA (news - web sites) has approved three drugs in the COX-2 class -- Vioxx, which Merck decided on its own to withdraw, Celebrex, made by Pfizer under the generic name celecoxib, and Pfizer's Bextra or valdecoxib.


The drugs are spectacularly successful, because they are designed to be taken long-term by patients with arthritis and other chronic ills. Makers had hoped they would be less likely to cause stomach bleeding and ulcers than older drugs called non steroidal anti-inflammatory agents or NSAIDS.


Topol, who served on the advisory committee that recommended approving the drugs, said the experts had strongly recommended a trial testing whether the drugs may raise heart risks.


"Unfortunately, such a trial was never done," Topol wrote.


"Meanwhile, Merck was spending more than $100 million per year in direct-to-consumer advertising -- another activity regulated by the FDA and a critical mechanism in building the 'blockbuster' status of a drug with annual sales of more than $1 billion."


Dr. Garret FitzGerald of the University of Pennsylvania said it was possible all COX-2 inhibitors could affect heart risk by acting on the epithelium that lines blood vessels.


"We now have clear evidence of an increase in cardiovascular risk that revealed itself in a manner consistent with a mechanistic explanation that extends to all the coxibs," he wrote in a separate editorial in the Journal.


"It seems to be time for the FDA urgently to adjust its guidance to patients and doctors to reflect this new reality. Only the FDA can provide unbiased and informed guidance; it has a role to play beyond watchful waiting."


FitzGerald said doctors should be cautious in prescribing COX-2 inhibitors to patients with heart disease.


The European Medicines Agency said earlier on Wednesday it would review the cardiovascular safety of COX-2 inhibitors and would strengthen existing warnings about them. "