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BY OUR PHARMA CORRESPONDENT
4 August, 2005: The Health Ministry of the government of India has asked to stop making and selling of all drug preparations containing valdecoxib. Through an order effective from July 25, 2005, the government asked all the companies selling valdecoxib in the market will have to withdraw their stocks.
The National Pharmacovigilance Advisory Committee (NPAC), a government body to monitor the safety standards of the drugs had recommended the ban of valdecoxib containing drugs about three months ago. NPAC had been asked to submit a report on the safety of the drug following the concerns raised against the new generation COX2 inhibitors. In the absence of any authentic data generated from within the country, the NPAC had taken serious note of the US FDA observations on the risk benefit profile of valdecoxib.
This is the second COX2 inhibitor after rofecoxib, to be withdrawn from Indian market.
A few of the valdecoxib makers including Ranbaxy Laboratories had voluntarily discontinued the sale of the drug after the reports that that US FDA asked Pfizer to suspend the sales of its arthritis drug, Bextra (valdecoxib), due to unfavourable risk benefit ratio.
Valdecoxib is a medicine that treats the pain and inflammation of arthritis.
On April 7, the United States Food and Drug Administration requested that Pfizer suspend sales of Bextra in the United States. The FDA is requiring all manufacturers of prescription non-steroidal anti-inflammatory arthritis medicines to provide additional information about cardiovascular and gastrointestinal risks. The FDA is also asked all the manufacturers of over-the-counter NSAIDs to revise their labels to include more information on cardiovascular, gastrointestinal and skin risks.
BY OUR PHARMA CORRESPONDENT
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