U.S. regulators have lagged behind some courts and health officials overseas in evaluating the safety of Abbott Laboratories’ weight-loss drug Meridia.
More than two years have passed since the consumer group Public Citizen called on the U.S. government to pull Meridia off the shelves, alleging deaths and adverse patient reactions since the drug was launched six years ago.
Meridia, which is still being sold, is one of only two prescription drugs approved in the U.S. as a long-term treatment for weight loss. The other is Xenical, sold by Roche AG.
The Food and Drug Administration still cannot say when it will issue a formal response to Public Citizen’s petition regarding Meridia.
“The FDA wants to make sure they have the most up-to-date adverse event data before responding [to Public Citizen’s petition], and because of internal procedural delays it held off an earlier response,” said FDA spokeswoman Laura Alvey.
“We have decided to make the adverse event data as up-to-date as possible, which is going to form the basis of our response,” Alvey said. “Having said that, we have no convincing or compelling evidence, based on our adverse event reporting system, that does not show that Meridia is safe and effective if used according to the label.”
Meridia’s sales growth in the U.S. has been affected by publicity surrounding lawsuits as well as the FDA’s delay, Wall Street analysts have said. Abbott would not comment on the FDA’s review or its effect on Meridia sales.
The company has been successful in battling other allegations about Meridia.
In July, for example, a federal judge in Ohio dismissed 113 of 120 cases against Abbott, saying plaintiffs failed to show sufficient evidence the drug harmed them. Abbott still faces seven cases in state courts involving claims related to Meridia.
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Furthermore, Abbott sales figures show Meridia sales have been growing outside the United States where the company satisfied some regulators who had concerns two years ago.
In 2002, European regulators deemed Meridia safe for the treatment of obesity following some reports in Italy that two patients had died after taking the drug. In those cases, no link between Abbott’s drug and the patients’ death was established.
Meridia sales outside the United States jumped 35 percent in the first half of this year, to $115 million from $85 million in the first half of 2003. By comparison, U.S. sales were largely flat at about $35 million in the first half of this year compared with the year-earlier period, Abbott said.
“Abbott is optimistic about Meridia based on the growing recognition about the seriousness of obesity as a disease, and the limited number of treatments available for obesity,” Abbott spokeswoman Laureen Cassidy said. “The European regulatory issues have been resolved, and the majority of the litigation in the U.S. has been addressed.”
Health-care exec retires: Longtime Northwestern Memorial HealthCare executive Kathleen Murray will retire later this month after 18 years in various senior positions.
Murray has been president and chief executive officer of Northwestern Memorial Foundation since 2001. Prior to that, she was executive vice president and chief operating officer of Northwestern Memorial Hospital and held a senior role in planning the hospital’s replacement facility.
“Kathy has successfully directed many strategic and operational initiatives, including the planning and construction of the redevelopment project, which led to the opening of the Feinberg and Galter pavilions in 1999,” said Gary Mecklenburg, president and CEO of Northwestern Memorial HealthCare, parent of the hospital, foundation and related entities.