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No Added Risk Seen From Ending Vioxx Use 2006-05-12
By Associated Press

No Added Risk Seen From Ending Vioxx Use

TRENTON, May 11 (AP) — Merck & Company said on Thursday that Vioxx users who were in the study that led to the drug's being pulled from the market were not at increased risk of heart attack or stroke in the year after stopping the drug.

Merck said data from a "preliminary safety analysis" of an additional year of patient follow-up, part of the study's original plan, did not show a statistically significant difference in the rate of heart attacks and strokes among patients who had been on Vioxx and those who had taken a placebo.

That means the differences over that year could have been a result of chance.

However, there was a higher rate of complications, mainly strokes, among those taking Vioxx over all four years covered in the new data: the original three years of the study and the follow-up year after patients were taken off the medicine.

Merck's general counsel, Kenneth Frazier, said the results would not change Merck's strategy of fighting, one by one, the many lawsuits filed by former Vioxx users and their families who are blaming the drug for heart attacks, strokes and deaths.

"We believe that the data don't provide for a claim for a patient who had an event after they stopped taking their medicine," Mr. Frazier said.

The company, based in Whitehouse Station, N.J., released the information after the stock market closed Thursday. Shares closed at $34.51, down 16 cents; they are more than 25 percent lower than when Merck pulled Vioxx from the market in September 2004. That was after data from the first three years of the study showed Vioxx doubled risk of heart attack and stroke after 18 months' use.

Merck faces about 10,000 lawsuits over Vioxx, including numerous potential class-action suits, and has lost half of the six cases to come to trial so far.

A Vioxx case that was scheduled to begin July 31 in Tampa, Fla. was postponed on Wednesday at the request of both the plaintiff and Merck.

Both sides said the necessary depositions would not be done by the trial's start date.

The case centers on Refic Kuzic, a retired professional soccer player, who suffered a nonfatal heart attack in 2001 after taking Vioxx for about two and a half months.

The next Vioxx case is set to be heard in New Jersey on June 5.


 
 
 
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