US consumer group asks FDA to ban Abbott diet drug

Abbott Laboratories Inc’s weight-loss drug Meridia should be banned immediately because of heart-related risks, a consumer group said on Thursday in a petition to U.S. regulators.

Public Citizen said early results from a large international study called Scout added to the group’s previous concerns that Meridia could cause heart problems.

“The fact that ( Meridia) actually increased the number and percentage of cardiovascular events (in the study) ... should mandate its immediate removal from the market,” Public Citizen, a consumer advocacy group, said in a petition filed with the Food and Drug Administration.

The FDA in November said preliminary findings from the 10,000-patient Scout study showed 11.4 percent of patients who took Meridia died or suffered a heart attack, stroke or cardiac arrest. The figure was 10 percent for patients who got a placebo.

The agency said at the time it was reviewing the data but it was too early to draw conclusions. An FDA spokeswoman on Thursday had no immediate comment on the Public Citizen petition.

Meridia is an appetite suppressant approved to treat obese adults. It can cause side effects ranging from headaches and constipation to higher blood pressure and a faster heart rate.

Abbott spokesman Kurt Ebenhoch said the drug was safe when used as directed. Meridia, or sibutramine, “is not recommended or approved for use in more than 90 percent of the patients who participated in the Scout study,” he said.

“While we haven’t reviewed the petition, Abbott’s assessment is the data do not indicate a change in the safety profile of sibutramine when used in the approved patient population,” he said.

Some of the patients in the Scout study took the drug for longer than the approved length of time, Ebenhoch added.

Public Citizen said 84 heart-related deaths had been reported to the FDA in patients who took Meridia. Thirty of the people who died were age 50 or younger, and 11 were age 30 or younger, the group said.

The reports do not prove a drug caused a problem, but the FDA uses the information to search for patterns.

The FDA rejected an earlier petition from Public Citizen to ban Meridia over cardiovascular risks. In that 2005 decision, the agency said the drug’s benefits outweighed its risks when used appropriately, adding it was not possible to conclude Meridia caused the reported problems.

Public Citizen said the FDA stated in its 2005 denial that an assessment of Meridia’s heart risks could best be made though a large trial such as Scout.

Meridia’s use has decreased in the United States over the past eight years, the consumer group said. Still, 294,000 U.S. prescriptions were filled for the drug in the last 12 months, the group said, citing data from IMS Health.

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* Public Citizen says Meridia increases heart risks

* Abbott says drug is safe when used as directed

By Lisa Richwine

WASHINGTON (Reuters)