Vioxx pulled from market

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Blockbuster Arthritis Drug Vioxx Recalled Worldwide

Drug Increases Risk Of Heart Attack, Stroke

 

POSTED: 8:27 am EDT September 30, 2004

UPDATED: 9:09 am EDT September 30, 2004

 

NEW YORK -- Pharmaceutical giant Merck & Co. is pulling its blockbuster

arthritis and acute pain drug Vioxx from the market worldwide because new data

from

a clinical trial found an increased risk of heart attack and stroke.

 

 

Merck said Thursday that data from the trial showed the increased risk of

heart attack and other cardiovascular complications began 18 months after

patients started taking Vioxx.

 

The company's decision, which is effective immediately, is based on new,

three-year data from a three-year study aimed at showing that Vioxx at a

25-milligram dose prevents recurrence of polyps in the colon and rectum. The

trial was

stopped after Merck discovered the higher heart risk compared to patients

taking dummy pills.

 

Merck had been conducting the clinical trial to evaluate the use of Vioxx for

the prevention of a recurrence of colorectal polyps.

 

In this study, there was an increased relative risk for confirmed heart

attack and stroke, beginning after 18 months of treatment in the patients taking

Vioxx, compared to those taking a placebo.

 

" We are taking this action because we believe it best serves the interests of

patients, " said Raymond V. Gilmartin, chairman, president and chief executive

officer of Merck. " Although we believe it would have been possible to

continue to market VIOXX with labeling that would incorporate these new data,

given

the availability of alternative therapies, and the questions raised by the

data, we concluded that a voluntary withdrawal is the responsible course to

take. "

VIOXX was launched in the United States in 1999 and has been marketed in more

than 80 countries. In some countries, the product is marketed as Ceoxx.

Worldwide sales of Vioxx in 2003 were $2.5 billion.

 

" While the cause of these results is uncertain at this time, they suggest an

increased risk of confirmed cardiovascular events beginning after 18 months of

continuous therapy. While we recognize that Vioxx benefited many patients, we

believe this action is appropriate, " said Peter S. Kim, Ph.D., president of

Merck Research Laboratories.

 

Merck has informed the U.S. Food and Drug Administration and regulatory

authorities in other countries of its decision. The company also is in the

process

of notifying health-care practitioners in the United States and other

countries where Vioxx is marketed. Patients who are currently taking Vioxx

should

contact their health-care providers to discuss discontinuing use of Vioxx and

possible alternative treatments. In addition, patients and health-care

professionals may obtain information from www.merck.com and www.vioxx.com, or

may call

(888) 36-VIOXX (1-888-368-4699).

 

Vioxx is the 16th most-used drug in the United States, according to CNN.

 

Before Thursday's announcement, Merck remained comfortable with its 2004

earnings per share guidance of $3.11 to $3.17. The company currently expects

earnings per share to be negatively affected by $0.50 to $0.60 as a result of

the

recall. Merck expects that worldwide about one month of inventory is held by

customers and will be returned.