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Meridia 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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Slimtech, 2 Day Diet, Miaozi Slim Spiked w/Drugs

Weight-Loss Products Illegally Spiked with Prescription Drugs

Some of the affected weight-loss products include Slimtech, 2 Day Diet and Miaozi Slim Capsules.  These supplements were spiked with drugs such as: 

  • Bumex
  • Sibutramine
  • Meridia
  • Bumetanide
  • Furosemide
  • Lasix
  • Rimonabant
  • Zimulti
  • Cetilistat

At least 72 weight-loss products have been found by the Food and Drug Administration (FDA) to contain prescription drugs, including four drugs not approved by the FDA for sale in the U.S., according to Public Citizen’s WorstPills.org.

This is the third time in the past six months that the FDA has announced alerts about the illegal addition of active prescription drug ingredients to otherwise ineffective weight-loss supplements.

Because the added drugs are active in the body, they can be dangerous as well. For instance, sibutramine (brand name Meridia, an appetite suppressant available by prescription only and a controlled substance) and fluoxetine (brand names Prozac and Serafem, an antidepressant available by prescription only) were among the drugs found in the supplements.

The FDA has inspected a number of companies associated with the sale of these illegal products and is currently seeking voluntary recalls of the 72 products.

Based on the FDA’s inspections and the companies’ responses to recall requests, the FDA may take additional enforcement steps, such as issuing warning letters or initiating seizures, injunctions or criminal charges.

“The FDA’s response has been inadequate,” said Sidney M. Wolfe, M.D., director of Public Citizen’s Health Research Group and acting Public Citizen president. “Some of the drugs found in these supplements are dangerous and are putting people at an unacceptable risk of injury. To protect citizens, the agency needs to go further and seize these products.”

The affected weight-loss products are categorized as dietary supplements by the FDA.

Dietary supplement manufacturers sometimes seek to gain a competitive advantage by clandestinely adding prescription drugs to a largely inactive dietary supplement.

Unfortunately for the companies, this has the side effect of converting these products from dietary supplements into prescription drugs. To sell prescription drugs without FDA approval is illegal, providing the basis for the FDA’s possible actions.

“Most dietary supplements do not fall under the jurisdiction of the FDA, but this is one case where all of these products are clearly in violation of the laws that govern drugs,” Wolfe said. “The FDA has not exercised its legal authority to seize all of these products and take them off the market, and anything short of that simply is not good enough.”

WorstPills.org includes the full list of 72 implicated weight-loss products, as well as the nine drugs they may contain.

These include, in addition to Meridia and Prozac/Serafem, fenproporex (a stimulant drug not approved for marketing in the U.S.); bumetanide (brand name Bumex, a potent diuretic available by prescription only); furosemide (brand name Lasix, a potent diuretic available by prescription only); rimonabant (brand name Zimulti, an appetite supp ressant not approved for marketing in the U.S.); cetilistat (an experimental obesity drug not approved for marketing in the U.S.); phenytoin (brand name Dilantin, an anti-seizure medication available by prescription only); and phenolphthalein (a solution used in chemical experiments and a suspected cancer-causing agent that is not approved for marketing in the United States).

Some of the affected weight-loss products include Slimtech, 2 Day Diet and Miaozi Slim Capsules. A full list of these products is available on WorstPills.org.

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