FDA Posts New Tamiflu Warning
About 100 Reports of Self-Injury and Delirium in Patients Taking the Flu Drug
Nov. 14, 2006 -- The FDA has announced a new warning for the flu drug
The new warning notes reports of self-injury and delirium in flu patients
taking Tamiflu, mainly among children in Japan.
The FDA knows of 103 reported cases -- 95 from Japan, five from the U.S.,
and three from other countries. Sixty of the 103 cases featured delirium with
prominent behavioral disturbance such as panic attack, hallucinations, and
convulsions; only one of those cases occurred in the U.S.
It's not known if Tamiflu caused any of those events.
"People with the flu, particularly children, may be at an increased risk
of self-injury and confusion shortly after taking Tamiflu and should be closely
monitored for signs of unusual behavior," states Tamiflu's new warning.
"Patients with influenza
a should be closely monitored for signs of abnormal behavior throughout
the treatment period," the warning also notes.
"A healthcare professional should be contacted immediately if the
patient taking Tamiflu shows any signs of unusual behavior," states the
The drug company Roche, which makes Tamiflu, sent a letter dated Nov. 13 to
health care workers about the new warning. Roche is a WebMD sponsor.
In a Roche news release, the drug company states that "while any
relative contribution of Tamiflu to these events is unknown, Roche is committed
to working closely with the FDA to ensure that the product label accurately
reflects the reports, so that healthcare professionals, as well as parents and
guardians, can closely monitor influenza patients for any signs of abnormal
Tamiflu is an oral flu treatment. It targets the flu virus and stops it from
spreading in the body. It can also reduce the chance of getting the flu. If you
are already coming down with flu, Tamiflu works best if taken within 48 hours
of the first flu symptoms.
Tamiflu was approved in 1999 and has been used by more than 42 million
people in over 80 countries, Roche states.
Roche and the FDA continue to monitor Tamiflu safety.
Any adverse events with Tamiflu should be reported to the FDA's MedWatch
program by phone at (800) FDA-1088 ((800) 332-1088) or online at
Adverse events with Tamiflu may also be reported to Roche by phone at (800)
526-6367 or by fax at (800) 532-3931.