FDA Advisors Back Stronger Flu Drug Warnings
Ilena Rose
Health Lover
http://www.reuters.com/article/scienceNews/idUSN2747283820071128?sp=true
By Kim Dixon
GAITHERSBURG, Maryland (Reuters) - U.S health advisers recommended on
Tuesday stronger warnings on the labels of flu drugs made by Roche
Holding AG and GlaxoSmithKline Plc, amid reports of abnormal and, in
the case of the Roche drug, sometimes fatal psychiatric behavior.
The U.S. Food and Drug Administration advisory panel reviewed the
small but rising number of cases, mostly in Japan, of patients taking
Roche's Tamiflu and Glaxo's Relenza who have experienced
hallucinations and delirium.
In the case of Tamiflu, some cases of erratic behavior, including
jumping from buildings, resulted in deaths.
Although no direct link with the antiviral drugs has been established,
the advisory panel recommended adding the new case reports to the
drugs' labels. The FDA typically takes the advice of its advisory
panels.
The meeting was the third public review of flu drug safety, originally
prompted by reports two years ago of a dozen deaths, including
suicide, of children in Japan who took Tamiflu.
"The public expects to be made aware. I never hear on the public side,
that they are getting too much information," said Dr. Michael Fant, a
pediatric expert at the medical school at the University of Texas, and
panel member.
"If we're still wrestling with it, to me even though we don't have
anything definitive, that in and of itself warrants conveying those
concerns to the public."
In March, Japan warned against prescribing Tamiflu to those aged 10 to
19 after reports of mostly young people showing signs of strange and
erratic behavior after taking the drug.
FDA staffers have recommended a stronger label warning for Tamiflu to
note patient deaths. For Relenza, addition of a warning about
hallucinations and delirium is recommended.
Several panel members said that noting the fatalities in patients
taking Tamiflu was appropriate in a new label, although a formal vote
on that issue was not taken. The panel voted to generally note the
newly reported cases of neuropsychiatric behavior seen with Relenza.
LINK UNCLEAR
Many of the experts said it should be noted that some unusual behavior
was observed in flu patients who did not take the drugs, suggesting a
possible link to the disease itself.
FDA staffers described reports of about 700 cases of psychiatric
adverse events for both drugs, and 25 cases of pediatric deaths in
patients taking Tamiflu, reported to the agency through May 2007. No
fatalities were reported for Relenza.
Three of the deaths occurred in the United States, and causes included
complications of flu.
Glaxo and Roche officials said they opposed label changes and cited
data showing no causal link between the drugs and adverse events. It
is "very difficult to differentiate drug from disease," Dr. Jonathan
Solsky of Roche told the panel.
About 48 million people worldwide have taken Tamiflu since it was
approved in 1999, according to Roche. Relenza has been used by about 4
million people since its launch in 1999.
The flu virus is a major cause of death and illness in the United
States. Complications from the illness kill about 36,000 Americans a
year, a government expert told the panel. Children and the elderly are
especially at risk.
One panel member said the benefits of Tamiflu are slim compared with
the risks, however rare and uncertain.
"When we give Tamiflu to children who have influenza, we shorten (the
duration of flu) by one day, a day and a half," said Dr. Keith Kocis,
a pediatric care doctor at the North Carolina Women's Hospital, and an
advisory panel member. "To me (the benefit is) relatively minor."
Dr. David Kimberlin of the University of Alabama in Birmingham was in
the minority when he warned against scaring the public, given the
uncertainty about cause and effect.
"People are going to hear death" and assume causality, he said. "I
think it's allowing an overstatement."
(Reporting by Kim Dixon; editing by Andre Grenon and Tim Dobbyn)