US FDA warns SuperGen on statements for cancer drug

14 March 2003 18:43  [Source: ICIS news]

WASHINGTON (CNI)--The US Food and Drug Administration (FDA) Friday warned consumers and health care professionals about misrepresentations in a SuperGen press release for a recently approved cancer drug.

FDA said today that the 15 November SuperGen press release for the drug Mitozytrex, "exaggerates the efficacy of Mitozytrex and fails to include the significant risks associated with the use of the drug."

"Indeed," said FDA, "the press release does not even mention acute adverse reactions that can result from administration of Mitozytrex, which include fever, anorexia, nausea, and vomiting." The release also failed to disclose that Mitozytrex is associated with myelosuppression and hemolytic uremic syndrome, according to the FDA statement.

The FDA detailed a list of what it describes as misrepresentations peppered throughout the SuperGen news release, most of them involving various unsupported claims. In one instance, according to FDA, the company identifies the drug in the news release as "MitoExtra," a name the FDA had explicitly rejected earlier because it "suggests clinical benefits that have not been substantiated by data."

Officials at the Dublin, California-based SuperGen could not be reached for comment.

Monitoring the marketing efforts of drug companies is an area the FDA has been pursuing with particular vigour in recent years. The FDA statement says that under the circumstances, the agency "determined it was imperative to correct the record."

It was unclear if the FDA is taking action further action in the matter. FDA officials could not be reached for comment Friday.

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