European Drug Agency Rules Against Abbott Diet Pill

WASHINGTON (Dow Jones)--European regulatory authorities on Thursday said an Abbott Laboratories (ABT) diet pill should be suspended from the market because the risks of stroke and heart attack are too great with the medicine.

The European Medicines Agency said sibutramine weight-loss products should be suspended from the market in the European Union after a study of 10,000 patients suggested it put them at a higher risk for heart disease. These medicines are sold in Europe under the brand-names Reductil, Reduxade, Zelium and other names; and as Meridia in the U.S.

The agency said "the risks of these medicines are greater than their benefits."

Abbott sells Meridia in the U.S. and Reductil, Sibutral, Raductil and Ectiva outside the U.S.

Shares of Abbott closed Thursday at $55.56, down 68 cents, or 1.2%.



The agency's decision will now get passed to the European Commission for review.

Abbott spokesman Kurt Ebenhoch said the company "respectfully" disagrees with the European agency's recommendation to suspend the medicine but will comply with the request. The product is still available for purchase outside the European Union.

Global sales for the product in 2009 were about $300 million, he said. Most of that came from outside the U.S.

The suspension means the product won't be available for purchase. It may be lifted if Abbott resolves the agency's concerns.

The news comes as the U.S. Food and Drug Administration said earlier Thursday that patients with a history of heart disease are not to use Meridia amid studies suggesting it causes heart attacks, strokes or death.

European and U.S. regulatory bodies operate independently of each other, and often come to different decisions about the safety of medicines.

The FDA said Abbott has agreed to update the drug's label to state the medicine isn't to be used in patients with a history of heart disease, including heart attacks, uncontrolled hypertension and heart-rhythm problems.

The label for Meridia had recommended the drug shouldn't be used in patients with a history of heart disease.

The announcements stem from a study of 10,000 patients that showed 11.4% of those who took Meridia had a cardiovascular event such as a heart attack, compared with 10% of patients who received a fake pill. The people in the study had a history of heart disease or diabetes plus a cardiovascular risk factor.

The study has already been completed. The FDA said it plans on holding an advisory committee meeting to further discuss the safety and risks with Meridia. The date will be set after the agency gets a report on the study from Abbott on Meridia. The agency expects to get Abbott's report on the study in March.

The FDA said patients using Meridia should contact their doctor to determine whether they should continue taking the medicine. The European Medicines Agency said doctors shouldn't prescribe the medicines, and patients should talk with their doctor. Meridia was approved in 1997 to help patients manage their weight.



-By Jared A. Favole, Dow Jones Newswires;

So, instead of taking expensive drugs which can ultimately lead to some nasty side effects, why not use The Diet Plate? No side effects, totally holistic and sold by Diabetes UK, British Heart Foundation and Cancer Research UK amongst others.