Roche and GlaxoSmithKline under-fire from consumers

A consumer group has told the Food and Drug Administration (FDA) in the United States that the Roche prescription diet drug Xenical should be removed from the market.

Public Citizen said that the drug should not be made readily available as it is linked with the growth of abnormalities on the lining of the colon. The group presented the FDA with a petition against the drug.

The petition follows the FDA announcement that the GlaxoSmithKline-proposed lower-dosage version of Xenical has been granted conditional approval for sale as a non-prescription drug.

“The failure to ban the prescription version of this drug, or worse, to make it much more widely available by allowing OTC [over the counter] sales is a decision that is likely to increase cancer incidence,” said Public Citizen’s Health Research Group director, Dr Sidney Wolfe.

Public Citizen is basing its dispute over the marketing of a non-prescription version of the product on a December 2005 study that showed Xenical caused the development of lesions that were an early sign of cancer.

The consumer group said that Xenical was not initially approved by the FDA because it found a “four-fold to seven-fold increased risk” of developing breast cancer in people taking the product.

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