Drug to combat swine flu leaves '1,000 patients in suffering'

Officials insist Tamiflu is safe as reports of side effects continue to rise

Health officials yesterday defended the Government's policy of giving the antiviral drug Tamiflu to everyone claiming to be suffering from the symptoms of swine flu despite more than 400 reports of adverse drug reactions since the start of the outbreak.

Critics of the policy of widespread distribution of Tamiflu have also warned that people who fail to complete the course of treatment may be fuelling the evolution of drug-resistant forms of the type of H1N1 influenza A virus behind the swine flu pandemic.

The Medicines and Healthcare products Regulatory Agency (MHRA) said yesterday that between 1 April and 6 August there had been 418 reports of adverse side effects to Tamiflu and a further 686 suspected cases of adverse reactions. Last week alone there were 125 reports of adverse side effects in people taking Tamiflu, although not all of them may be due to the drug, the MHRA said.

For the same four-month period, there were 10 reports of adverse reactions and 14 suspected side effects in people taking Relenza, the other anti-viral drug used to treat swine flu symptoms. Unlike Tamiflu, which is a pill taken orally, Relenza is taken as a nasal spray.

A spokesman for the Department of Health said that Britain is a world leader in monitoring the side effects of drugs and that this is done precisely so that health authorities can make sure that such treatments are safe and effective.

"Both Relenza and Tamiflu have been through rigorous safety and efficacy tests. They are effective against swine flu and help relieve the symptoms and length of infection," he said.

"As with many medicines, a small proportion of patients may experience some side effects, and nausea is one of them. Side effects are clearly indicated on patient information leaflets. A safety-first approach of offering antivirals to everyone remains a sensible and responsible way forward," he added.

About 300,000 people have been given Tamiflu since the start of the swine-flu outbreak and anyone who fulfils the criteria of the National Pandemic Flu Service can collect the drug free of charge after answering a series of questions about their symptoms on a questionnaire completed online or over the telephone.

A spokesman for the MHRA spokesman said that both Tamiflu and Relenza are acceptably safe medicines and that most people will not suffer any side effects. "The potential side effects are listed in the product information. The MHRA will continue to monitor the safety of Tamiflu and Relenza as their use increases during the swine-flu pandemic and we will take appropriate action should any new risks come to light," he said.

"There is a dedicated team which monitors the incoming reports from the public and healthcare professionals on an ongoing basis. The balance of risks and benefits for Tamiflu and Relenza remains positive," he added.

Tamiflu, which is manufactured by Roche, has vomiting and nausea listed as its main side effects on its packaging. A total of 11 per cent of adults and adolescents taking the drug experience nausea and 8 per cent suffer from vomiting, according to the summary of product characteristics.

Headaches are another side effect when the drug is taken preventatively rather than as a treatment. In children, the most commonly reported side effect is vomiting, with 15 per cent suffering it, and 10 per cent having diarrhoea. A total of 3 per cent of children will get nausea and 5 per cent have reported abdominal pain.

Andrew Castle: 'Tamiflu almost killed my daughter'

*Georgina Castle was one of the first people to suffer serious side effects from Tamiflu during a swine flu outbreak at her school in May. The 16-year-old was prescribed a double dose of the drug because she had asthma but within hours she was in hospital suffering from severe complications.

Yesterday her father, the GMTV presenter and former tennis star Andrew Castle, challenged the Health Secretary Andy Burnham live on television over the Government's policy of just "handing out" the drug without a proper diagnosis. Mr Castle said: "I can tell you that my child – who was not diagnosed at all – she had asthma, she took Tamiflu and almost died."

Mr Burnham said he sympathised with Mr Castle, saying it must have been "very worrying", but maintained that advice to parents to treat swine flu with Tamiflu remained unchanged.

Speaking after the programme Mr Castle said he had been shocked at how quickly his daughter's condition deteriorated. "She had a very quick descent and within 12 hours she had developed terrible breathing difficulties and seemed to be turning blue. We spoke to a GP friend of ours who advised us to call an ambulance. In the end she spent three days in hospital."

Mr Castle's wife Sophia said even at the hospital, doctors still wanted to give her the drug. "I told them: 'I don't want my daughter to have it,'" she said. "But they insisted. It was only when she tested negative for swine flu that they agreed to stop." Georgina went on to make a full recovery but her parents said they are still concerned that Tamiflu is being overprescribed while the side effects are not fully understood.

"I've told everybody I know: 'Don't give that drug to your child,'" said Mrs Castle.

"At Georgina's school we've heard stories about girls who took it getting depression during their A-levels."

Her husband added: "We've got a number of friends who are GPs and they are concerned about this. We appear to be handing out Tamiflu willy-nilly without being aware of its effects."