US reviews risks of Tamiflu after 12 children die

The safety of Tamiflu, the anti-flu drug, has been questioned for the second time in a week following reports that it has been linked to the deaths of 12 children in Japan.

The drug is being stockpiled by governments around the world preparing for a threatened flu pandemic, but American drug regulators are to review its status today.

European regulators said on Monday they were monitoring the psychological effects of the drug after it was linked to the suicides of two Japanese teenagers.

In a report posted online, the US Food and Drug Administration said yesterday that 12 children had died in Japan from causes including heart attack, suicide, pneumonia and acute pancreatitis. Four had suffered a "sudden death", which was "an unusual phenomenon in otherwise healthy children". All had taken Tamiflu.

"Deaths from influenza are uncommon among both children with and without high-risk conditions, but do occur," the FDA report said. "Attribution of causality for the reports of sudden death and cardio-pulmonary arrest are extremely difficult to interpret because there is limited information leading up to the event." It added that it was "concerning" that 32 psychiatric events, such as hallucinations and abnormal behaviour, had been reported in children who took Tamiflu.

A panel of the FDA is examining reports of adverse reactions to Tamiflu as part of a wider review of how medicines work in children. One question they will have to address is how to distinguish the effects of the drug from the effects of the flu.

In a separate summary posted on the FDA web site, Roche, the manufacturer of Tamiflu, said: "There is no increase in deaths and neuropsychiatric events in patients on Tamiflu versus influenza patients in general." Officials from the FDA and the Swiss drugs giant will present information about the cases to an FDA advisory panel today.

Demand for Tamiflu has soared as avian flu, which has killed at least 64 people in the Far East, has spread to birds and poultry Europe. At least 50 countries including the US, UK and Japan have placed orders worth $1.4bn (£810m) to prepare for a flu pandemic experts say is inevitable.

The British Government has ordered 14.6 million courses of Tamiflu at a cost of £200m. Three million courses have been delivered and the remainder is due by September next year.

Japan is the only country with extensive experience of Tamiflu. The drug is routinely used by all sectors of the population during the winter flu season to shorten the duration of the illness, reduce complications and slow its spread. The Japanese health ministry issued a warning in June last year about psychological and neurological disorders linked with Tamiflu.

The European Medicines Evaluation Agency (EMEA), which licenses drugs in the EU, said that it had asked Roche to follow closely reports of psychological disorders, delusional states and abnormal behaviour linked with the drug.

In the UK, Tamiflu has been little used since its launch in 2003 and there have been only 41 "yellow card" reports linked with it of adverse reactions, involving 161 separate side-effects. One case was of agitation and two were of "confusional state". Under the yellow card system doctors record symptoms that could be linked with a drug. The reports are intended to provide early warning of possible problems.

In the UK, the side effects listed for Tamiflu include nausea, fatigue, insomnia, dizziness, rash and - rarely - hepatitis and Stevens-Johnson syndrome, a life-threatening condition in which the skin blisters and sloughs off.

The two Japanese boys who died in separate accidents were reported to have exhibited abnormal behaviour after taking the drug. A high school student of 17, who was at home alone, ran out of his house and jumped over a railing into the path of a lorry in February 2004, shortly after taking the medicine. In the second case, a 14-year-old apparently fell from the ninth floor of his apartment building in February 2005.

In a statement issued last night, the EMEA said it had asked Roche to "provide a cumulative safety review of all available data on serious psychiatric disorders, including all case reports with a fatal outcome where Tamiflu was involved".

News
i100
News
Netherlands' goalkeeper Tim Krul fails to make a save from Costa Rica's midfielder Celso Borges during a penalty shoot-out in the quarter-final between Netherlands and Costa Rica during the 2014 FIFA World Cup
newsGoalkeepers suffer from 'gambler’s fallacy' during shoot-outs
News
people
Arts and Entertainment
Standing the test of time: Michael J Fox and Christopher Lloyd in 'Back to the Future'
filmReview: A week late, Secret Cinema arrives as interactive screening goes Back to the Future
PROMOTED VIDEO
Have you tried new the Independent Digital Edition apps?
News
ebookA unique anthology of reporting and analysis of a crucial period of history
Travel
travel
Arts and Entertainment
Sydney and Melbourne are locked in a row over giant milk crates
artCultural relations between Sydney and Melbourne soured by row over milk crate art instillation
Arts and Entertainment
Adèle Exarchopoulos and Léa Seydoux play teeneage lovers in the French erotic drama 'Blue Is The Warmest Colour' - The survey found four times as many women admitting to same-sex experiences than 20 years ago
filmBlue Is The Warmest Colour, Bojack Horseman and Hobbit on the way
Arts and Entertainment
Preparations begin for Edinburgh Festival 2014
Edinburgh festivalAll the best shows to see at Edinburgh this year
News
Two giraffes pictured on Garsfontein Road, Centurion, South Africa.
i100
Environment
View from the Llanberis Track to the mountain lake Llyn
Du’r Arddu
environmentA large chunk of Mount Snowdon, in north Wales, is up for sale
Independent
Travel Shop
the manor
Up to 70% off luxury travel
on city breaks Find out more
santorini
Up to 70% off luxury travel
on chic beach resorts Find out more
sardina foodie
Up to 70% off luxury travel
on country retreats Find out more
Latest stories from i100
Have you tried new the Independent Digital Edition apps?
Independent Dating
and  

By clicking 'Search' you
are agreeing to our
Terms of Use.

iJobs Job Widget
iJobs General

Financial Accountants, Cardiff, £250 p/day

£180 - £250 per day + competitive: Orgtel: Financial Accountants - Key Banking...

Regulatory Reporting-MI-Bank-Cardiff-£300/day

£200 - £500 per day + competitive: Orgtel: I am currently working on a large p...

Recruitment Consultant - Bristol - Computer Futures - £18-25k

£18000 - £25000 per annum + Commission: SThree: Computer Futures are currently...

Trainee Recruitment Consultant - Real Staffing - Leeds - £18k+

£18000 - £27000 per annum + Commission: SThree: Sales - Trainee Recruitment Co...

Day In a Page

Dress the Gaza situation up all you like, but the truth hurts

Robert Fisk on Gaza conflict

Dress the situation up all you like, but the truth hurts
Save the tiger: Tiger, tiger burning less brightly as numbers plummet

Tiger, tiger burning less brightly

When William Blake wrote his famous poem there were probably more than 100,000 tigers in the wild. These days they probably number around 3,200
5 News's Andy Bell retraces his grandfather's steps on the First World War battlefields

In grandfather's footsteps

5 News's political editor Andy Bell only knows his grandfather from the compelling diary he kept during WWI. But when he returned to the killing fields where Edwin Vaughan suffered so much, his ancestor came to life
Lifestyle guru Martha Stewart reveals she has flying robot ... to take photos of her farm

Martha Stewart has flying robot

The lifestyle guru used the drone to get a bird's eye view her 153-acre farm in Bedford, New York
Former Labour minister Meg Hillier has demanded 'pootling lanes' for women cyclists

Do women cyclists need 'pootling lanes'?

Simon Usborne (who's more of a hurtler) explains why winning the space race is key to happy riding
A tale of two presidents: George W Bush downs his paintbrush to pen father’s life story

A tale of two presidents

George W Bush downs his paintbrush to pen father’s life story
Restaurateur Mitch Tonks has given the Great Western Pullman dining car a makeover

The dining car makes a comeback

Restaurateur Mitch Tonks has given the Great Western Pullman dining car a makeover
Gallery rage: How are institutions tackling the discomfort of overcrowding this summer?

Gallery rage

How are institutions tackling the discomfort of overcrowding this summer?
Louis van Gaal has £500,000 video surveillance system installed to monitor Manchester United players

Eye on the prize

Louis van Gaal has £500,000 video surveillance system installed to monitor Manchester United players
Women's rugby: Tamara Taylor adds fuel to the ire in quest to land World Cup

Women's rugby

Tamara Taylor adds fuel to the ire in quest to land World Cup
Save the tiger: The day America’s love of backyard tigers led to a horrific bloodbath

The day America’s love of backyard tigers led to a horrific bloodbath

With only six per cent of the US population of these amazing big cats held in zoos, the Zanesville incident in 2011 was inevitable
Samuel Beckett's biographer reveals secrets of the writer's time as a French Resistance spy

How Samuel Beckett became a French Resistance spy

As this year's Samuel Beckett festival opens in Enniskillen, James Knowlson, recalls how the Irish writer risked his life for liberty and narrowly escaped capture by the Gestapo
We will remember them: relatives still honour those who fought in the Great War

We will remember them

Relatives still honour those who fought in the Great War
Star Wars Episode VII is being shot on film - and now Kodak is launching a last-ditch bid to keep celluloid alive

Kodak's last-ditch bid to keep celluloid alive

Director J J Abrams and a few digital refuseniks shoot movies on film. Simon Usborne wonders what the fuss is about
Once stilted and melodramatic, Hollywood is giving acting in video games a makeover

Acting in video games gets a makeover

David Crookes meets two of the genre's most popular voices