Consumer Group Seeks Abbott Diet Drug Ban

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Health - Reuters

 

Consumer Group Seeks Abbott Diet Drug Ban

Wed Sep 3, 4:27 PM ET Add Health - Reuters to My

 

 

 

WASHINGTON (Reuters) - Consumer advocacy group Public Citizen on

Wednesday renewed its call for U.S. regulators to ban Abbott

Laboratories Inc.'s diet drug Meridia, saying it had seen links to

further deaths.

 

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Since its March 2002 petition for a ban that cited 19 heart-related

deaths since Meridia's 1998 U.S. launch, Public Citizen said it had

looked at another 18 months of data and found an additional 30

cardiovascular deaths in people using the drug.

 

 

" The reactions are serious, the number of victims is rising rapidly

and the effectiveness in treating obesity is meager, " said Dr.

Sidney Wolfe, director of Public Citizen's Health Research Group, in

a statement announcing the second petition to the Food and Drug

Administration (news - web sites).

 

 

But Abbott said the latest submission to the FDA reflected a pattern

of irresponsible conduct by Public citizen, adding that obesity

itself was a serious threat to public health with an accompanying

risk for premature death and cardiac problems.

 

 

" The safety of Meridia has been comprehensively re-examined by

global regulatory authorities, including the European Committee for

Proprietary Medicinal Products and Canadian Health authorities, and

(they) have concluded there has been no change to the risk/benefit

profile of Meridia, " the company said in a statement.

 

 

FDA spokeswoman Laura Bradbard said the agency was studying the data

and working to respond to the petition.

 

 

Public Citizen said it was also seeing in the FDA's own database a

link to spontaneous abortions, stillbirths and congenital defects

when pregnant women take the drug.

 

 

" The FDA is in possession of evidence sufficiently clear to

immediately ban this serious health hazard, known to cause dangerous

increases in blood pressure, " said Wolfe.

 

 

Public Citizen said it based the call for a ban on its analysis of

data from the FDA Adverse Event Reporting System.

 

 

Of the 30 newest cardiovascular deaths among Meridia users, 25

reports provided ages and 17 of those people, or 68 percent, were

younger than 50, according to Public Citizen's submission to the

FDA.

 

 

Since the 1998 U.S. launch of Meridia through March 2003, there were

also 124 serious cardiovascular events requiring hospitalization,

Public Citizen said.