Reuters Health Information (2004-07-13): GlaxoSmithKline vaccine information wrong - US FDA
GlaxoSmithKline vaccine information wrong - US FDA
Last Updated: 2004-07-13 14:42:37 -0400 (Reuters Health)
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 incorrect flu vaccine recommendations, the U.S. Food and Drug
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
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