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Tamiflu should not be given to children with flu: study

Japan's Daiichi Sankyo says new flu drug effective
A new influenza drug under development has been shown to be as safe and effective as Tamiflu in clinical trials, Japanese pharmaceutical maker Daiichi Sankyo Co. said Monday. The drug, known as CS-8958 or Laninamivir, demonstrated the same level of efficacy as Tamiflu for adults and was even more effective among children, the company said in a statement. Laninamivir, co-owned with Australia's Biota Holdings Ltd., is expected to be effective for treating seasonal and swine flu, and has also shown efficacy against the H5N1 avian flu virus in non-clinical tests, it said. "Laninamivir offers a new therapeutic agent in the treatment of influenza with particular advantages for stockpiling applications," Biota managing director Peter Cook said in a separate statement. Daiichi said it would apply to regulators by March for approval to sell the drug in Japan, where it has the marketing rights. A licensing partner is being sought for all other markets. Sales of Tamiflu, made by Swiss pharmaceutical giant Roche, have soared following the emergence of the A(H1N1) swine flu virus and its rapid spread around the world to pandemic levels.
by Staff Writers
Paris (AFP) Aug 10, 2009
Children with seasonal flu should not be given Tamiflu because harmful side effects may outweigh relatively meagre benefits, according to a study released Monday.

In some children Tamiflu caused nausea and vomiting, which can lead to dehydration and other complications, researchers reported.

The study did not cover the current outbreak of swine flu, but it suggests that antivirals may not significantly reduce the length of illness or prevent complications in children infected with the new A(H1N1) virus, the researchers said.

Carl Henegan, a doctor at John Radcliffe Hospital in Oxford and co-author of the study, said the current British practice of giving Tamiflu and Relenza -- the brand names for the antivirals oseltamivir and zanamivir -- for mild illness was "an inappropriate strategy."

"The downside of the harms outweigh the one-day reduction in symptomatic benefits," he said.

The research showed that both antivirals shortened the duration of seasonal flu by 12 to 36 hours.

But the drugs had little or no effect on asthma flare-ups, increased ear infections or the need for antibiotics.

In addition, Tamiflu was linked to an increased risk of vomiting.

The study, published in the British Medical Journal (BMJ), comes 10 days after Britain's Health Protection Agency (HPA) reported that more than half of 248 students given Tamiflu after a classmate fell ill with swine flu suffered side-effects such as nausea, insomnia and nightmares.

Most of the students did not have the flu when they were given the drug.

Vaccines are the frontline defence against influenza, but in Britain and elsewhere antivirals are often prescribed -- for treatment and prevention -- when vaccines are in low supply or simply unavailable, as in the case of swine flu.

The BMJ study, led by David Mant of Oxford University, concludes that a "more conservative strategy" in administering the drugs is probably in order.

The researchers reviewed four earlier clinical trials -- two with Relenza and two with Tamiflu -- for influenza treatment covering 1,766 children 12 or younger. More half had confirmed cases of type A flu.

They also reviewed three other trials in which the drugs were given to children who had been exposed to the virus but showed no symptoms.

Such "proactive" use resulted in only an eight percent reduction in the incidence of influenza, though earlier studies have shown a higher rate of protection.

None of the trials reviewed by the BMJ tested the efficacy of anti-virals against the new strain of swine flu that has swept across the globe since April, infecting hundreds of thousands and claiming more than 1,100 lives.

Swiss pharmaceutical company Roche, the patent holder of Tamiflu, suggested that the symptoms described in the study might been due in part to the flu itself and not the medication.

"According to the WHO, 50 percent of patients with the flu (swine or seasonal) have nausea symptoms or digestive problems caused by the illness," a Roche spokesman told AFP.

"Clinical studies on children treated with Tamiflu have shown secondary effects such as nausea, but these have been moderate and it is extremely rare that treatment must be halted as a consequence," the spokesman said.

Tamiflu is a so-called neuraminidase inhibitor that acts by blocking a viral enzyme that allows the flu virus to invade cells in the respiratory tract.

The drug can be prescribed from the age of one year old.

Severe symptoms in Japanese children taking Tamiflu reported earlier this decade -- delirium, hallucinations, encephalitis and 12 deaths -- were probably due to factors independent of the drug, according to several health authorities that investigated the cases, including the US Food and Drug Administration.

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India swine flu death toll increases to six: officials
Mumbai (AFP) Aug 10, 2009
The number of people to die from swine flu in India rose to six, health officials said Monday, as the government called for calm and people flocked to public hospitals for tests. The latest to die of the (A)H1N1 virus were an ayurvedic or traditional medicine practitioner in Pune, 120 kilometres (75 miles) from India's financial hub Mumbai, and a four-year-old boy in the southern city of Che ... read more







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