There is no evidence of a link between Tamiflu and the sudden deaths of 12 children in Japan who took the drug, The US Food and Drug Administration has concluded.
Roche, the Swiss pharmaceutical giant which markets the drug standing in the front line of defense against a bird flu pandemic, agreed to work on changing the drug's labeling to warn of potential dermatological side-effects, reports AFP.
AdvertisementBut the powerful US medicines regulator found unanimously that there was no 'causal link between pediatric deaths and neuropsychiatric adverse events and Tamiflu,' an FDA statement said after a hearing of its paediatric safety panel.
Roche said it 'intends to work with the FDA to change the drug's labeling based on adverse skin events that have occurred in a small number of patients, mostly in Japan.'
'We welcome the outcome of the FDA advisory committee and look forward to working with the FDA and other health authorities to extend our knowledge of the use of Tamiflu and its safety profile,' said William Burns, head of Roche's pharma division. 'The positive role of Tamiflu remains unchanged,' he added.
Reports in Japan have said Tamiflu may have been a factor in several suicides by children aged under 16 who took Tamiflu to treat influenza. The FDA has detailed 75 cases of mental and skin disorders worldwide, including 69 in Japan. The European Union's drugs agency has also asked Roche for a safety review into the drug.
Documents posted on the FDA website attributed increased reports of psychiatric disorders among Japanese children who have taken Tamiflu to a variety of probable causes. Those included increased awareness of flu-associated brain disease, increased access to Tamiflu in Japan, and an accompanying focus by the media and health regulators on potential side-effects.
Countries have placed huge orders for Tamiflu to guard against a feared pandemic of flu that could derive from the H5N1 avian influenza virus.
The strain has killed more than 60 people in Southeast Asia since 2003 and since last month has been found in Europe, Canada and the Middle East.
Japan has become the single-biggest purchaser of Tamiflu. A health ministry report Monday said that in the worst-case scenario of a mass flu outbreak, up to 640,000 people could die in the densely populated country.
Tamiflu was one of eight drugs being reviewed by the FDA committee 12 months after they were approved for use by children.
Roche insisted to the FDA hearing that Tamiflu is safe, and that more than 30 million people worldwide -- including 11.6 million under-16 in Japan and the United States -- have taken the influenza treatment safely since 2001.
Approximately three to five million people worldwide catch flu each year, resulting in 250,000-500,000 deaths, according to statistics from the WHO.
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