Tamiflu side effects in children

New research claims that “more than half of children taking Tamiflu to combat swine flu suffer side effects such as nausea, insomnia and nightmares,” said The Daily Telegraph. It also said the study suggests that one in five children who took part reported having a neuropsychiatric side effect, such as poor concentration, inability to think clearly, problems sleeping, and feeling dazed or confused.

This online survey looked at schoolchildren’s adherence to Tamiflu and any side effects they experienced. It had a low response rate, and no control group against which to compare the symptoms. As such, it is not possible to say for sure that this frequency of side effects is precise. It is possible that the rate of symptoms in a school that closed down because of a new epidemic would have been quite high anyway, whether pupils were given the drug or not. No serious or long-term side effects of the drug were reported.



Where did the story come from?
The research was carried out by Dr Aileen Kitching from the European Programme for Intervention Epidemiology Training and colleagues from the Health Protection Agency (HPA) in London. The funding for this HPA study is not reported. The study was published in Eurosurveillance, the peer-reviewed journal of the European Centre for Disease Prevention and Control.



What kind of scientific study was this?
The aim of this research was to survey schoolchildren’s adherence to oseltamivir (Tamiflu), any side effects they experienced, and how often they experienced them.

The study was conducted between April and May 2009, when a number of London schools with confirmed cases of swine flu were advised to close. At this time, antiviral prophylaxis with Tamiflu was offered to close contacts of cases. The researchers say that family doctors in London at the time reported a number of patients (mainly children and adolescents) who had to stop the drug because of side effects (non-compliance).

Three independent (non-state) schools took part. Parents were emailed the web address of an online anonymous questionnaire, along with a letter that described the study, and sought consent and participation. Parents or guardians could complete the questionnaire on behalf of younger children.

Participants for the study were selected differently in the three schools. In two schools (one primary and one secondary school) the researchers selected all the classes who were offered prophylaxis, (age 4-11 years in the primary school), and all of one year group in the secondary school (age 13-14 years). In the other secondary school, the questionnaire was offered only to pupils in four of the classes in the year group (age range 11-13 years).

The questionnaire asked a series of questions, including:

•whether children who had been offered Tamiflu had taken it,
•how long they took it for,
•the presence or absence of influenza-like symptoms before taking Tamiflu,
•any other medication taken with Tamiflu,
•symptoms after taking Tamiflu (including specific gastrointestinal and neuropsychiatric symptoms).
Parents were also asked for their comments. As the information was required quickly, the weblink to the questionnaire was emailed to parents/pupils on the morning of May 14, and the questionnaire closed at midnight. The researchers used the responses to deduce who had been given the drug as prophylaxis (prevention) rather than treatment.



What were the results of the study?
Out of a possible 256 schoolchildren, 103 replied (a response rate of 40%). Response rates were better from the secondary schools than the primary school. The researchers estimated that most of those who responded (95) were given Tamiflu for prophylaxis. Of those, only 85 (89%) took the drug. The 10 who did not take Tamiflu were all primary school pupils.

Less than half (48%) of primary schoolchildren completed a full course, compared to three-quarters (76%) of secondary schoolchildren.

More than half (45 out of 85) of schoolchildren (53%) who were taking it as prophylaxis reported one or more side effects. The most common side effects were gastrointestinal symptoms, such as nausea and vomiting, which were reported by 40% of children. The second most common were mild neuropsychiatric effects, reported by 18% of children. These were most frequently difficulty sleeping, bad dreams/nightmares or poor concentration.

Most parents reported in the comments section that they made their own risk assessment for their child. They were sceptical of the need for medication to prevent onward transmission, and they questioned the scientific basis of the advice. They also raised the possibility that Tamiflu may be doing more harm than good compared to the ‘risk’ from swine flu. They wanted more information about the type and nature of any potential side effects in order to make informed decisions.



What interpretations did the researchers draw from these results?
The researchers say that their results confirmed GPs’ suspicions that children were adhering poorly to Tamiflu. They also said that it is ‘timely information with which to assist decision-making.’



What does the NHS Knowledge Service make of this study?
These results should be used in conjunction with other information to make informed decisions about Tamiflu. As there was no control group to compare against the children given tamiflu, and the survey had a low response rate, there are several points to be aware of when interpreting these figures:

•These side effects are recognised adverse effects of the medication, and have been reported in previous literature on the topic. Controlled trials of Tamiflu found that nausea occurs twice as frequently with the drug as with placebo, with about 20% of people given the drug reporting nausea or vomiting. Although controlled clinical trials do not always accurately represent what happens in settings outside of an organised trial, the results from these clinical trials suggest that the actual rate of side effects might be less than the levels seen in this study.
•The fact that the responses were requested within less than 24 hours may have contributed to the low response rate. The 60% of people who did not respond to the survey may differ from those who had the time to respond. Perhaps they were in larger families. It is not known how the results would have been affected if non-responders had been included.
•Relying on the responses to a questionnaire to determine whether children and adolescents had flu or side effects from medication might have caused some inaccuracies. With a proportion of cases of swine flu thought to remain asymptomatic (at least to begin with), it is possible that some of these children actually developed flu itself in the few days after the first case.
This study was carried out at a time when Tamiflu was being given to slow the spread of the virus. As with all drugs, the benefits and risks of taking Tamiflu need to be considered by individual patients and their healthcare providers in the context of their risk and symptoms at the time. No serious or long-term side effects of the drug were reported.

Advice for pregnant women & general advice

Pregnant women are one of the higher risk groups for swine flu, as they are for all influenza viruses. It is therefore important for them to take precautions.

This website provides full and up-to-date advice for pregnant women and parents of young children. The advice has not changed recently and is available at the following links:

Swine flu advice for pregnant women.
Swine flu pregnancy and parenting Q&A.
Swine flu symptoms, including high-risk groups.
Chief medical officer's advice on pregnancy, holidays, and parents.

Reduce the risk of catching or spreading flu

Cover your mouth and nose when coughing or sneezing. Use a tissue.
Dispose of used tissues carefully.
Wash your hands frequently with soap and water.
Clean hard surfaces (e.g. kitchen worktops, door handles) frequently using a normal cleaning product.

How dangerous is swine flu?
The vast majority of cases reported so far in this country have been mild. Only a small number have led to serious illness, and these have frequently been where patients have had underlying health problems.

There has been an argument put forward that the government should restrict antivirals to those groups who are most at risk of developing serious complications from swine flu. In other words, if people are otherwise healthy, then the NHS should let the virus run its course, treating it with paracetamol and bed rest, as for normal flu.

However, the government’s Scientific Advisory Group for Emergencies (SAGE) believes there is still some uncertainty about the risk profile of the virus. For instance, there are reports of some cases in Argentina where young, healthy adults have apparently become extremely ill from swine flu.

While there is still this doubt, the government has decided to continue offering Tamiflu to everyone with swine flu at their doctor's discretion.

"We will keep this matter under review, with advice from SAGE," said health minister Andy Burnham.

You can read the Department of Health's guide for further information on the science of swine flu treatment.

Which groups are at greatest risk?
Some people are more at risk than others of serious illness if they catch swine flu. They will need to start taking antivirals as soon as they are confirmed with the illness. On occasion, doctors may advise some high risk patients to take antivirals before they have symptoms if someone close to them has swine flu.

The risk profile of the virus is still being studied but it is already known that certain groups of people are particularly vulnerable. These include:

•Patients who have had drug treatment for asthma in the past three years
•Pregnant women
•People aged 65 years and older
•Children under five years old
•People with chronic lung disease
•People with chronic heart disease
•People with chronic kidney disease
•People with chronic liver disease
•People with chronic neurological disease
•People with immunosuppression (whether caused by disease or treatment)
•People with diabetes mellitus

Latest updates on Swine Flu

While the government has orderded enough vaccine for the entire population this will take time to produce, and so the most vulnerable groups will be given priority to receive initial stocks of the jab.


Andy Burnham said that the earliest doses of vaccine would be given to at-risk groups in the following order:

•People aged between six months and 65 years in the clinically at-risk groups for seasonal flu
•Pregnant women, subject to licensing by the European Medicines Agency, which will indicate whether it can be given throughout pregnancy or only at certain stages of pregnancy
•Household contacts of people with compromised immune systems
•People aged 65 and over in the current seasonal flu vaccine clinical at-risk groups
The health secretary said: “Although the virus has so far proved to be mild in most people, for others it has been more serious. By vaccinating high-risk groups first, we aim to protect those most vulnerable to this virus”. He also confirmed that frontline health and social care workers will also begin to be vaccinated at the same time as the first at-risk group.



At-risk groups
At-risk groups will be the same as for seasonal flu vaccination, and include people with serious heart disease, diabetes, and those with weakened immune systems due to cancer treatment.

The list has been drawn up according to advice from independent experts at the Joint Committee on Vaccination and Immunisation, which reviewed the evidence and advised the Department of Health on the crucial risk groups to be offered vaccination to help prevent serious illness.

A vaccination programme for the rest of the population will be based on the evolution of the pandemic as well as new clinical data on the use of the vaccine.

People in the priority groups outlined above do not need to take any action yet. Further announcements will be made as the vaccination strategy progresses, and those who need a vaccine will be contacted.



Weekly pandemic flu update
Other key points made at this week’s briefing by the chief medical officer (CMO) included:

•There has been a further reduction in the rates of flu-like illness and related activity this week. There were an estimated 25,000 new cases last week compared to 110,000 new cases two weeks before.
•Weekly GP consultation rates decreased over the last week in England.
•There are 371 patients in hospital with swine flu, 39 of whom are in critical care.
•There have been 44 confirmed deaths in England, bringing the UK total to 49.
•There is still no sign of the virus mutating into a more dangerous form, or developing resistance to drugs.


Vaccine progress
The World Health Organization (WHO) confirmed last week that the first swine flu vaccines are likely to be licensed for use in the general population in September. Initial batches of an H1N1 vaccine have already been produced, and clinical trials are underway.

"The quality controls on today's vaccine are much better than they were 30 years ago," said the WHO, which also oversees the safety checks on the seasonal flu jab.

10 home remedies to avoid swine flu

Are the rising swine flu casualties giving you jitters? Not sure how you can avoid falling prey to the growing epidemic? First and foremost, there
is absolutely no need to panic.

Watching television to keep tabs on the progress of H1N1, particularly in the badly affected areas like Pune, is all right. But don't let the hysterical anchors get under your skin and start wearing a mask each time you step out of the house, unless you are visiting a very crowded area. Then too, the mask will protect you only for a specified period.

Without giving in to the swine flu panic and creating a stockpile of Tamiflu and N-95 masks at home and enriching pharma companies, there are a number of other measures you can take to ensure that the virus is not able to get you, irrespective of which part of the world you are in.

It is essential to remember that all kinds of viruses and bacteria can attack you when your immune system is weak, or they can weaken it easily. Hence, building your own defences would be a better, more practical, long-lasting and much more economical idea.

Here are some easy steps you can take to tackle a flu virus of any kind, including swine flu. It is not necessary to follow all the steps at once. You can pick and choose a combination of remedies that suit you best. However, if you are already suffering from flu, these measures can help only up to an extent. And, if you have been infected by H1N1, visiting a hospital and staying in solitary confinement is a must.

1. Have five duly washed leaves of Tulsi (known as Basil in English; medicinal name Ocimum sanctum) everyday in the morning. Tulsi has a large number of therapeutic properties. It keeps throat and lungs clear and helps in infections by way of strengthening your immunity.

2. Giloi (medicinal name Tinospora cordifolia) is a commonly available plant in many areas. Take a one-foot long branch of giloi, add five to six leaves of Tulsi and boil in water for 15-20 minutes or long enough to allow the water to extract its properties. Add black pepper and sendha (salt used during religious fasts), rock or black salt, or Misri (crystalised sugar like lumps to make it sweet) according to taste. Let it cool a bit and drink this kadha (concoction) while still warm. It will work wonders for your immunity. If giloi plant is not available, get processed giloi powder from Hamdard or others, and concoct a similar drink once a day.

3. A small piece of camphor (kapoor) approximately the size of a tablet should be taken once or twice a month. It can be swallowed with water by adults while children can take it along with mashed potatoes or banana because they will find it difficult to have it without any aides. Please remember camphor is not to be taken everyday, but only once each season, or once a month.

4. Those who can take garlic, must have two pods of raw garlic first thing in the morning. To be swallowed daily with lukewarm water. Garlic too strengthens immunity like the earlier measures mentioned.

5. Those not allergic to milk, must take a glass of hot or lukewarm milk every night with a small measure of haldi (turmeric).

6. Aloe vera (gwarpatha) too is a commonly available plant. Its thick and long, cactus-like leaves have an odourless gel. A teaspoon gel taken with water daily can work wonders for not only your skin and joint pains, but also boost immunity.

7. Take homeopathic medicines — Pyrogenium 200 and Inflenzium 200 in particular — five tablets three times a day, or two-three drops three times a day. While these are not specifically targeted at H1N1 either, these work well as preventive against common flu virus.

8. Do Pranayam daily (preferably under guidance if you are already not initiated into it) and go for morning jog/walk regularly to keep your throat and lungs in good condition and body in fine fettle. Even in small measures, it will work wonders for your body’s resistance against all such diseases which attack the nose, throat and lungs, besides keeping you fit.

9. Have citrus fruits, particularly Vitamin C rich Amla (Indian gooseberry) juice. Since fresh Amla is not yet available in the market (not for another three to four months), it is not a bad idea to buy packaged Amla juice which is commonly available nowadays.

10. Last but not the least, wash your hands frequently every day with soap and warm water for 15-20 seconds; especially before meals, or each time after touching a surface that you suspect could be contaminated with flu virus such as a door handle or a knob/handle, especially if you have returned from a public place or used public transport. Alcohol-based hand cleaners should be kept handy at all times and used until you can get soap and warm water.