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New warning over anti-flu drug29 March 2007
Routine safety monitoring has suggested that the anti-flu drug oseltamivir (Tamiflu) may cause serious side-effects in young people, which could lead to possible accidental self-harm. Two teenagers died last month in Japan after showing signs of unusual behaviour. They both fell from apartment buildings and had recently taken oseltamivir. Since oseltamivir was approved in Japan in 2001, 12 children have died while taking the drug. Most of them died while they were asleep but two children had also behaved strangely before their deaths in 2005. They are thought to have experienced psychiatric effects including disturbed state of mind (delirium) and hallucinations. At the time, the US Food and Drug Administration said it was not possible to confirm a link between the children taking oseltamivir and their deaths. The European Medicines Agency (EMEA) also said that no causal relationship had been established connecting them to oseltamivir. However, the two latest deaths have caused the EMEA to change its recommendations. It now wants all packets of oseltamivir to carry a new health warning to make people aware of these reported behavioural side-effects. The agency's Committee for Medicinal Products for Human Use advises that this should say: "Convulsion, depressed level of consciousness, abnormal behaviour, hallucinations and delirium have been reported during Tamiflu administration, leading in rare cases to accidental injury. Patients, especially children and adolescents, should be closely monitored and their healthcare professional should be contacted immediately if the patient shows any signs of unusual behaviour." However, a spokesperson from the committee said that when oseltamivir is taken in line with this advice, the benefits outweigh the risks. Oseltamivir is the main drug used to treat and prevent flu and is only available on prescription. It is recommended by the World Health Organization as the best option for treating patients who have the H5N1 strain of bird flu. The drug is thought to have been taken by over 33 million people across the world since its approval in 2001, with over 24 million of these coming from Japan. The rate of deaths in people who have taken oseltamivir is just under five per million prescriptions and is therefore considered to be low. Q and A sectionWhy has the government bought oseltamivir?The government is making preparations in case of a flu pandemic caused by a new strain of the virus developing. Nobody would have immunity to this and so it could spread very quickly. However, it is thought that using oseltamivir would reduce the consequences. The government has enough oseltamivir to treat one-quarter of the UK population, as recommended by the World Health Organization. How would a new strain develop?If someone with human flu caught bird flu at the same time the two viruses could mix and produce a new strain. What is the current situation in the UK?In February 2007, the H5N1 strain of bird flu was found at a turkey farm in Suffolk. More than 160,000 birds were culled and the farm workers were given oseltamivir as a precaution. Since this outbreak there have been no further incidences. Has anyone in the UK caught bird flu?No. There have not been any cases in the UK of humans developing bird flu. Worldwide, there have been 278 confirmed cases and 168 deaths from bird flu, mostly in Asia and Africa. Those who died had all been in very close contact with infected birds. Are poultry and eggs safe to eat?Yes. The Food Standards Agency has said that as long as poultry and eggs are hygienically stored and prepared, and thoroughly cooked, it is safe to continue eating them. Further information
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