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FDA: Glaxo Vaccine Information Wrong

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FDA: Glaxo Vaccine Information Wrong
Tue Jul 13, 2004 01:39 PM ET
Source: Reuters.com

WASHINGTON (Reuters) - Product materials for several GlaxoSmithKline Plc hepatitis vaccines contain false information about flu vaccines that could lead to public health problems, U.S. regulators said in a letter released on Tuesday.

Hepatitis vaccines Havrix, Twinrix and Engerix-B all included the company's version of general U.S. government vaccine guidelines but listed false flu vaccine recommendations, the U.S. Food and Drug Administration wrote.

Glaxo's chart creates "a serious public health concern because it could lead to incorrect administration" of the live attenuated influenza vaccine to pregnant women with medical problems and very young children -- for whom the drug has not been shown to be safe, the letter said.

The U.S. Centers for Disease Control and Prevention recommends flu vaccines for healthy people aged 5 to 49. The GlaxoSmithKline chart recommended the vaccine for children 6 months to 5 years old and for adults up to age 50, according to the FDA.

The wrong information was a particular concern because it "was distributed during the height of the flu season," the agency also said.

Glaxo spokeswoman Amanda Foley said the British drugmaker thought the information "was in compliance with FDA policies. Any omissions and statements the FDA objected to were not intentional."

The materials were distributed in late 2003 until early this year but have been discontinued, Foley said, adding that corrected information would be sent out.

Foley also said the company was reviewing all of its vaccine promotional materials to make sure they were FDA compliant.

The letter, which was dated July 6, was posted on Tuesday on the FDA Web site at www.fda.gov.

Materials for the hepatitis vaccines also failed to list critical safety warnings, including adverse reactions and medical conditions that should prevent some patients from getting the vaccine, the FDA said.

The agency sends dozens of similar warning letters each year. While most are resolved without regulatory action, the FDA can impose injunctions, fines and other penalties.



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