Sunday, June 12, 2005

[FDA] US regulator suppresses vital data on prescription drugs on sale in Britain

News: "US regulator suppresses vital data on prescription drugs on sale in Britain | By Roger Dobson and Jeanne Lenzer | 12 June 2005

'IoS' investigation: Despite calls for more transparency after revelations about the side effects of ibuprofen, the FDA has withheld 28 pages of information on a new wave of painkillers

Vital data on prescription medicines found in millions of British homes has been suppressed by the powerful US drug regulators, even though the information could potentially save lives.

An investigation by The Independent on Sunday shows that, under pressure from the pharmaceutical industry, the American Food and Drug Administration routinely conceals information it considers commercially sensitive, leaving medical specialists unable to assess the true risks.

One team of investigators found that 28 pages of data had been removed from the FDA files on one of a new family of painkillers because of confidentiality.

Last week a major research study led by Professor Julia Hippisley-Cox at Nottingham University, revealed that ibuprofen, the supposedly "safe" painkiller, increases the risk of heart attack by almost a quarter. The finding was a particular blow to thousands of users who have already switched from the best-selling drug Vioxx, which was withdrawn last year after evidence that it too could increase the risk of heart attacks. ...

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