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SafetyAlerts
August 16,  2002

Statement from FDA Deputy Commissioner Crawford
Regarding Metabolife

(SafetyAlerts) - Three weeks ago, the FDA asked the Department of Justice to pursue a criminal investigation of Metabolife - whether they made false statements to FDA regarding the existence of adverse event reports.

Since at least 1997, the FDA has tried to get these adverse event reports from industry. The FDA also unsuccessfully sought these reports through litigation. Metabolife has refused and resisted us every step of the way.

Given their long history of being uncooperative, we view their offer to make these reports available now to be disingenuous. We are greatly disturbed that Metabolife has repeatedly refused to cooperate with the FDA, and news that so many reports exist greatly heightens our concern.

Once we get these reports, the FDA will have a special task force review them.

Remember, Congress placed the burden on the Secretary of Health and Human Services to prove that these products are unsafe. Thus, the Secretary called for an extensive scientific review of ephedra in June to establish a scientific base for addressing health concerns around ephedra. The Rand Corporation is conducting a comprehensive review of the existing science on ephedra, and the NIH will use this information to guide an expanded research effort on the safety of the product.

Consumers may wish to consult their physicians before using this product."

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Source: FDA

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.