Arthritis Drugs Celebrex-Vioxx Safety in Doubt by Margot B

Several doctors say they are worried about the possibility of heart attacks

because many of the arthritis patients taking the drugs are elderly and have a

higher risk of cardiovascular problems to begin with.

The current debate centers on whether the higher heart attack rate found in

patients taking Vioxx is a result of the drug’s actually causing damage in some

patients or to an absence of the heart-protecting benefits that Naproxen may

have.

“Naproxen had a similar anti-platelet effect to aspirin,” said Dr. Eve E.

Slater, senior vice president of external policy for Merck’s research labs,

“and those people had fewer heart attacks.”

Neither Vioxx nor Celebrex has been shown to have the same heart-protecting

benefit.

Slater also said that Stover’s report was flawed and biased in favor of

Pharmacia. But regulators and some doctors say they still worry that there may

be more of a problem with Vioxx.

And even if Vioxx and Celebrex do not damage the heart, the fact that they do

not have the heart-protecting benefits of aspirin reduces the ability of the

companies to market them as being significantly safer than other pain relievers.

Merck recommended last year that doctors involved in clinical trials of Vioxx

consider prescribing low doses of aspirin to patients taking Vioxx if they are

at high risk of heart attacks - although low doses of aspirin could increase the

risk of ulcers. Ulcers are the main side effect that Vioxx and Celebrex were

developed to avoid.

There have been no studies done to determine whether patients have fewer ulcers

if they take low doses of aspirin with either Vioxx or Celebrex. In February

Dr Maria Lourdes Villalba, at an FDA advisory meeting, stated that Merck had

proved Vioxx [Rofecoxib] caused fewer serious ulcers than Naproxen. However,

she also state that the potential safety advantage was offset by a higher risk

of heart problems,in her opinion. She reported that “Overall, there was no

safety superiority of Rofecoxib over Naproxen, mainly due to an excess of serious

cardiovascular events”.

Dr Villalba also stated that there had been no studies to prove Merck’s claim that

Naproxen worked like aspirin in decreasing heart attacks. The FDA expressed some

concern over the higher rate of heart attacks with Vioxx, stating that this could

be caused by the drug’s ability to produce blood clots.

“There is still a tremendous benefit with these drugs” reported Dr Eve Slater of

Merck.

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BIO:

Margot B, Writer, Web Developer
Margot B has written a book and hundreds of articles, specializing in health and the environment.

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