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FDA Bans Sale of Bextra Joint Ache Painkiller

Apr 13, 2005 | Bangkok Post

The Food and Drug Administration has followed the US FDA's lead by banning the sale of Bextra, a kind of painkiller for joint aches which puts users at risk of heart attack and skin conditions.

The US FDA on April 7 asked Pfizer to withdraw Bextra from the market and announced actions to be taken regarding the marketing of NSAIDs (non-steroidal anti-inflammatory drugs).

FDA secretary-general Pakdi Pothisiri said the FDA had sought approval from the public health minister to ban the sale of Bextra in Thailand, and asked importer Pfizer (Thailand) Co to withdraw the drug.

All hospitals and provincial public health offices nationwide have been told to stop prescribing the drug.

The move came after the FDA's side-effects follow-up centre learned that the US FDA had found that Bextra, a non-steroidal anti-inflammatory drug under the COX-2 inhibitor drug group for joint complaints, posed risks of heart attack and skin diseases.

Pfizer has agreed to withdraw the medicine from the market, Mr Pakdi said.

The FDA would decide whether to revoke Bextra's production licence after consulting the pharmaceutical committee and considering further information from the US and European FDAs.

In Thailand, Bextra has been available only at hospitals.

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