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No evidence to link Tamiflu with child deaths
The US Food and Drug Administration on Friday asserted that they have as yet not found any connection between Tamiflu, manufactured by Swiss drugmaker Roche and the deaths among children in Japan using the drug. The FDA, which makes recommendations for agency regulations, examined thoroughly Tamiflu data, in particular the Japanese regulatory reports of 12 deaths among 75 cases of dangerous symptoms in children.
However, the US regulatory panel did maintained that this antiviral drug used for flu treatment must be monitored closely in the next couple of years to test if they are harmful to children's health.
Chairman of the US paediatric advisory panel, Dr Robert Nelson, said on the basis of data analyzed, no relation has been established between Tamiflu and deaths.
Providing clinical test results and an epidemiological assessment, Roche proclaimed that Tamiflu users recorded fewer or equal number of cases of symptoms and deaths as the kids using placebo.
However, Roche also vowed to continue working along with the regulators to watch out for atypical symptoms and even health hazards in kids making use of this drug.
The panel's evaluation of the drug was all the more crucial as Tamiflu is used as a major treatment in government and medical preparations. In fact, this drug, which is used to fight virus after infection, has been in great demand given the apprehensions over bird flu outbreaks.
The committee was unanimous in its decision to vote for the FDA and will provide it with the preliminary information next year regarding unpleasant symptoms observed in Tamiflu consumers and later, a full report in two years time.
This because they were convinced that the FDA is committed to keep the public informed over drug safety concerns. It can be recalled that FDA's recommendations led to Merck, the US drugmaker, pulling out of the market their best-selling pain medication Vioxx last year.
Dr Linda Lewis, from the FDA's antiviral drug division, explained to the committee that the agency was making an effort to be as transparent and meticulous as possible.
FDA believes proper US scrutinizing of Japan's use of Tamiflu and its safety system would provide crucial clues relating to death hazards, brain aliments and other psychiatric signs.
The Tamiflu drug is utilized by Japanese three times more than the rest of the globe put together.
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Written
by :
Paul Robinson | Published on :
05:03:00
EST
Sat, 19 Nov 2005 |
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