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Department of Justice
Office of Public Affairs
FOR IMMEDIATE RELEASE
Monday, July 2, 2012
GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data
Largest Health Care Fraud Settlement in U.S. History

 

Except to the extent that GSK has agreed to plead guilty to the three-count criminal information, the claims settled by these agreements are allegations only, and there has been no determination of liability.

 

This landmark settlement demonstrates the Department’s commitment to protecting the American public against illegal conduct and fraud by pharmaceutical companie” said Stuart F. Delery, Acting Assistant Attorney General for the Justice Department’s Civil Division.

 

Doctors need truthful, fair, balanced information when deciding whether the benefits of a drug outweigh its safety risks.  By the same token, the FDA needs all necessary safety-related information to identify safety trends and to determine whether a drug is safe and effective. 

 

Unlawful promotion of drugs for unapproved uses and failing to report adverse drug experiences to the FDA can tip the balance of those important decisions, and the Justice Department will not tolerate attempts by those who seek to corrupt our health care system in this way

 

Tamiflu

Death is not an acceptable outcome of treating self-limiting flu.

 

Tamiflu patients should be monitored, FDA says

Patients who take Tamiflu should be closely monitored for signs of abnormal behavior, health officials said Monday in announcing an updated...

Los Angeles Times and The Associated Press

WASHINGTON — Patients who take Tamiflu should be closely monitored for signs of abnormal behavior, health officials said Monday in announcing an updated label for the antiviral flu drug.

The added precaution comes after reports of more than 100 cases of delirium, hallucinations and other unusual psychiatric behavior in people treated with the drug, which is usually taken to prevent or lessen the severity of the flu.

The Food and Drug Administration said that a relationship between the drug and the behavior had not been established and that the updated label was "intended to mitigate a potential risk associated with Tamiflu." It recommends that close monitoring begin immediately after starting treatment with the drug.

Tamiflu's maker, Hoffman-La Roche Inc., said there was no evidence the drug caused the side effects. Both the company and the FDA noted that severe cases of the flu can spark the abnormal behavior flagged in the updated label.

 

 

Alarming deaths of Tamiflu patients - FDA to investigate

Published on November 20, 2005 at 3:44 PM ·

U.S. Food and Drug Administration are investigating the deaths of 12 children
in Japan who took Roche's flu-fighting drug Tamiflu.

The U.S. regulators say it is difficult to tell whether the drug played a role in any of the cases but is concerned that 32 psychiatric events, such as hallucinations and abnormal behavior, have been reported in children who took Tamiflu.