HomeMeridiaMeridia diet pills under FDA review

Meridia diet pills could be pulled: FDA

Source:  The Associated Press

Federal health scientists in the U.S. are considering pulling Abbott Laboratories’ diet pill Meridia off the market, based on data that it increases heart attack and stroke.

The U.S. Food and Drug Administration has posted its safety review of Meridia online, ahead of a meeting where outside experts will weigh in on the drug’s heart risks.

The FDA will ask its experts to consider a range of actions for restricting sibutramine, sold as Meridia, including pulling the drug from the market.

Meridia has been on the market in the U.S. since 1997, but data released late last year showed patients taking the drug had more than 11 per cent risk of heart attack and stroke compared with 10 per cent of those taking placebo.

European regulators pulled the product off the market in January.

Health Canada said Monday it is aware of the FDA meeting, and like the U.S. regulator, is reviewing the results of the sibutramine cardiovascular outcomes (SCOUT) trial.

“Should the review identify new safety concerns, Health Canada will take appropriate action and inform health-care professionals and Canadians as soon as possible,” the department said in an email.

In January, Health Canada said it is conducting a review of new safety information for sibutramine, which is sold in Canada.

In October 2007, Health Canada reminded health-care workers to review the product’s guidelines before prescribing the drug, and for consumers to review the section on “when it should not be used.”

The regulator also regularly advises people not to use unapproved health products that have been found to contain undeclared sibutramine.

Meridia diet pills could be pulled: FDA

Last Updated: Monday, September 13, 2010 | 4:11 PM ET Comments19Recommend10

Federal health scientists in the U.S. are considering pulling Abbott Laboratories’ diet pill Meridia off the market, based on data that it increases heart attack and stroke.

The U.S. Food and Drug Administration has posted its safety review of Meridia online, ahead of a meeting where outside experts will weigh in on the drug’s heart risks.

The FDA will ask its experts to consider a range of actions for restricting sibutramine, sold as Meridia, including pulling the drug from the market.

Meridia has been on the market in the U.S. since 1997, but data released late last year showed patients taking the drug had more than 11 per cent risk of heart attack and stroke compared with 10 per cent of those taking placebo.

European regulators pulled the product off the market in January.

Health Canada said Monday it is aware of the FDA meeting, and like the U.S. regulator, is reviewing the results of the sibutramine cardiovascular outcomes (SCOUT) trial.

“Should the review identify new safety concerns, Health Canada will take appropriate action and inform health-care professionals and Canadians as soon as possible,” the department said in an email.

In January, Health Canada said it is conducting a review of new safety information for sibutramine, which is sold in Canada.

In October 2007, Health Canada reminded health-care workers to review the product’s guidelines before prescribing the drug, and for consumers to review the section on “when it should not be used.”

The regulator also regularly advises people not to use unapproved health products that have been found to contain undeclared sibutramine.

Read more: http://www.cbc.ca/health/story/2010/09/13/meridia-fda.html#ixzz129MffGGv

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