E-DRUG: Abnormal reaction to Tamiflu medicine tied to deaths of two boys
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[Copied from Ip-health]
As we stockpile: pharmacovigilance concern on Tamiflu (Oseltamivir) must be hightened and product literature updated if causality is established in the two cases below.
Current literature states:
1. Unlike Amantadine and Rimantadine, Neuraminidase inhibitors like Oseltamivir do not appear to adversely affect the CNS (AHFS Drug Information, 2002)
2. DIZZINESS, HEADACHE, FATIGUE, INSOMNIA and VERTIGO occurred during studies. Postmarket reports include SEIZURE and CONFUSION; causality is unknown (Prod Info Tamiflu(R) oseltamivir phosphate capsules and for oral suspension, 2001).
Jude Nwokike MPH
monkiyke@yahoo.com
[Copied for 'fair use' from Mainichi Daily News
http://mdn.mainichi-msn.co.jp/national/news/20051112p2a00m0na030000c.html\]
Abnormal reaction to Tamiflu medicine tied to deaths of two boys
Two boys have died after reacting abnormally to the flu medicine Tamiflu,
with one plunging to his death from a condominium and the other jumping in
front of a truck, a doctor has announced.
Even though a document attached to Tamiflu warns that the drug could cause
abnormal behavior or hallucinations, this is the first time that such a
reaction has led to a death.
The Health, Labor and Welfare Ministry has confirmed the cause of death of
at least one of the boys was the result of side-effects from the drug.
The doctor, Rokuro Hama, who heads the Japan Institute of Pharmacovigilance
for Evidence-Based Healthcare, will report the details of their deaths in a
session of the Japanese Society for Pediatric Infectious Diseases under way
in Tsu, Mie Prefecture.
A 17-year-old high school boy took a Tamiflu capsule at his home in Gifu
Prefecture in February last year after being diagnosed as suffering from
influenza, Hama said. While all his family members were away from home, he
suddenly jumped over the fence around his home even though it was snowing at
the time. He then jumped over a guardrail, hitting an oncoming truck and
died.
Chugai Pharmaceutical Co., the importer of Tamiflu, reported the incident to
the Health, Labor and Welfare Ministry, saying that the possibility that the
medicine caused his odd behavior cannot be ruled out.
A 14-year-old junior high school boy also took a Tamiflu capsule at his home
in Aichi Prefecture at around 4 p.m. on Feb. 5 this year after he was
diagnosed with the flu. About two hours later, he was found lying on the
ground in front of the condominium where he lived. His fingerprints were
found on a handrail on the ninth floor of the complex, leading police
investigators to suspect that he plunged to his death.
The boys had never shown any abnormal behavior before they took Tamiflu.
Besides these fatal cases, a teenage girl attempted to jump from a window
two days after taking Tamiflu, but her mother managed to stop her.
(Mainichi)
November 12, 2005