Bird Flu Medicine Toxic For Teens

[Sunshine123]

05-13-2008 17:40
Bird Flu Medicine Toxic for Teens

http://www.koreatimes.co.kr/www/news/nation/2008/05/117_24103.html

By Bae Ji-sook
Staff Reporter

Concerns are rising over side effect of bird flu drug Tamiflu on teenagers.

Tamiflu is Swiss-based Hoffman-La Roche's antiviral for general influenza A and B but is also used to combat bird flu. However, worries have surfaced about the possibility of the medicine causing mental disorders among teenagers.

With fear of the H5N1 virus sweeping the nation, the government has doubled the quantity of the drug in storage, as it is the most effective treatment against avian influenza.

Whether to prescribe the pills with risks of side-effects such delusions or other disorders is being widely discussed among medical experts.

Although the drug has been the only medicine accredited to be effective against the H5N1 virus strain by the World Health Organization (WHO), the Japanese and Korean governments restricted its being prescribed to teenagers last year.

The Korea Food and Drug Administration announced that the drug should not be prescribed to those between 10 to 19 years old except for emergencies.

According to Roche, there has not been a reported case of side effects here, but the Seoul Shinmun, a local daily, reported that a woman in her 30s said she had nightmares after taking the drug in 2005.

The government's decision came after Japanese health authorities banned its prescription for teenagers in March 2007.

Japan has imported the drug since 2001, long before its effect on bird flu was acknowledged.

However, since then, there have been 1,268 cases of extraordinary behavior reported, of which 85 percent were from teenagers. They reportedly committed suicide by jumping out of buildings or into cars.

Health experts admit to the dilemma and said when necessary, it should be prescribed with extra prudence.

``We will have no option but to give out the pill once someone contracts the disease. But for teenagers we need to be extra careful and make sure it is prescribed at the most appropriate time,'' Korean Pharmacists for a Democratic Society spokesman Shin Hyeong-geun said. ``Let's hope we will never have to worry about that.''

bjs@koreatimes.co.kr

 

[Snowy Owl]

Re: Bird Flu Medicine Toxic For Teens

Japan has expressed this concern.

Hippocampus
Posted 02-28-2007, 09:03 AM


Japan concerned by abnormal behavior linked to influenza and/or Tamiflu use
Japan investigates possible Tamiflu link to suicides
http://www.abc.net.au/news/newsitems...2/s1858783.htm

The Japanese Health Ministry says since November, 54 people have died after taking Tamiflu. (Reuters)

Japan has ordered an investigation into the possible psychiatric effects of the bird flu drug Tamiflu after a string of suicides allegedly linked to the medicine.
Swiss pharmaceutical giant Roche has been defending its drug since last year, when reports first surfaced in Japan of 'Tamiflu suicides'.
In the latest case, a 14-year-old boy was pronounced dead today after leaping from the 11th floor of a condominium in the northern Japanese city of Sendai.
"According to our information, the boy woke up in the middle of night after taking the medicine," a local police spokesman said.
"His mother suggested he go use the bathroom, but he opened the front door instead to go outside, and jumped off.
"The mother immediately rushed out to stop him, but it was too late."
In another case allegedly linked to Tamiflu, a 14-year-old girl jumped to her death earlier this month from a condominium in central Aichi prefecture.
The health ministry said it would study Tamiflu, but stopped short of immediately linking the drug to the deaths.
"The connection has not been made clear, but if that's the case then we will have to study special measures," Health Minister Hakuo Yanagisawa said.
The ministry ordered Japan's Chugai Pharmaceutical Co., which imports the drug, to provide information to assist a government investigation into the latest deaths.
As of November last year, 54 people have died after taking Tamiflu, 16 of whom were 16 years old or younger, the health ministry said.
The cases led to a probe by the US Food and Drug Administration, which concluded last year that there was no evidence linking Tamiflu and the deaths in Japan.
Tamiflu is considered a front line drug against a potential pandemic of bird flu or other forms of influenza.
Japan buys more than 60 per cent of the world's Tamiflu as a protective stockpile.
- AFP

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[Snowy Owl]

Re: Bird Flu Medicine Toxic For Teens

03-22-2007, 09:40 AM
Possibilities
Resident

Join Date: Feb 2007
Posts: 11
Tamiflu Warning in Japanese Teenagers
http://www.msnbc.msn.com/id/17708897/
Prospects for Tamiflu, Roche's blockbuster flu antiviral drug, were dealt a big blow on Tuesday after Japanese regulators called on doctors to stop prescribing it to teenagers.

The ministry of health and welfare in Tokyo asked Chugai, the local subsidiary of Roche of Switzerland, to change the labelling to say it should not be given to those between 10 and 20 years old, except for high-risk patients.
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The move follows an investigation launched by the ministry last month triggered by the suicides of two teenagers who had taken Tamiflu, adding to at least 16 deaths by under 16-year-olds in the country since the drug was launched in 2001.

The decision could sharply affect sales of Tamiflu in Japan, currently the world's largest user of the drug, also known by its generic name oseltamivir, because it is one of the few countries to prescribe it widely as a treatment for seasonal flu.

However, the ruling could have far broader implications, since Tamiflu sales ? which reached $2.1bn last year ? have risen sharply since 2005 as governments around the world have stockpiled the drug in large quantities to help prevent and treat a future flu pandemic.

At a press conference on Wednesday, Tatsuo Kurokawa, councilor at the Japanese health ministry's secretariat, said: "While we are not positive about the causal relations between Tamiflu and the falls, we think that a separate measure from a different perspective is necessary."

Mikio Ueno, vice president of Chugai, said: "It is true that there are people who have encountered these accidents. It happened and we decided to work with the ministry as a preventative step." Mr Ueno added that his company still believed in the benefits of Tamiflu.

Rokuro Hama, chairman of Japan Institute of Pharmacovigilance, a non profit organisation, described the ministry's response as "half baked". It made no sense, he said, to recommend not giving Tamiflu to those over 10 years old but continuing to advocate its use in younger children. "I think it's completely wrong," he said, adding that Tamiflu produced "sudden" side-effects in young children.

Roche has been encouraging the expansion of Tamiflu sales through new formulations designed for children, encouragement of its use in treating seasonal flu and greater stockpiling as a prophylactic in the event of a pandemic.

The company confirmed on Tuesday night that the ministry had requested a change to the labelling of the drug, while calling the decision "difficult to understand" and in contradiction to clinical studies. It said it would open discussions immediately with Chugai.

Martina Rupp, a spokeswoman for Roche, said that no causal link has been established between Tamiflu use and neuro-psychiatric disorders, and that flu was often associated with fevers and delirium which could result in suicide attempts.

She stressed that 42m people had taken the drug with very low rates of side effects.

Late last year the US Food and Drug Administration required a label change for the drug to reflect concerns about potential side effects.
Copyright The Financial Times Ltd. All rights reserved.

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[Snowy Owl]

Re: Bird Flu Medicine Toxic For Teens

11-27-2007, 06:19 PM
hawkeye
Administrator, Editor

Join Date: Feb 2006
Posts: 3,798
Tamiflu under Observation
Tamiflu under Observation

20:50, November 27th 2007

The FDA has appointed a Food and Drug Administration panel on Tuesday which will review reports of abnormal behavior and other brain effects in more than 1,800 children who had taken the flu medicine Tamiflu since its approval in 1999, including 55 in the USA.

Twenty-two of the U.S. reports were considered "serious," with symptoms such as convulsions, delirium or delusions, says Terry Hurley, spokesman for drugmaker Roche Laboratories.

None of the U.S. cases resulted in death. But in Japan, Hurley says, five deaths have been reported in children under 16 as a result of neurological or psychiatric problems. "Four were fatal falls, and one was encephalitis in a patient with leukemia," he says.

In addition, in people ages 17 to 21, there were two deaths in Japan, one a "fatal accident with abnormal behavior," Hurley says, and the second as a result of encephalopathy, a brain infection. Seven adult deaths attributed to neuropsychiatric problems also have been reported in Japan.

However, Hurley says there is no evidence Tamiflu caused the episodes and notes that similar symptoms have been reported in flu patients who had not taken Tamiflu. He says clinical studies have found no increased risk for psychiatric or neurologic disturbances, and the company's evaluation of scientific data found no "potential mechanisms for Tamiflu to cause (central nervous system) effects." He says the company is doing further studies.

The possible association between Tamiflu and neuropsychiatric effects was first reported in Japan, and in March, the Japanese government issued a safety warning restricting the drug's use in adolescents.

http://www.flutrackers.com/forum/showthread.php?t=42490&highlight=Tamiflu+deaths+japan

 

[Snowy Owl]

Re: Bird Flu Medicine Toxic For Teens

03-04-2008, 04:13 PM
Shiloh
Senior Member

Join Date: Feb 2008
Posts: 886
Tamiflu Gets New Warning on Psychiatric Side Effects
Source: http://www.newsinferno.com/archives/2673
Tamiflu Gets New Warnings on Psychiatric Side Effects
Date Published: Tuesday, March 4th, 2008
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Tamiflu prescribing information has been updated to include information about a variety of neurological and behavioral symptoms associated with the drug, the Food & Drug Administration (FDA) announced today. The decision to change the Tamiflu package insert followed the recommendation of an FDA Advisory Panel in November. The FDA Tamiflu advisory panel had reviewed more than 600 cases of Tamiflu psychiatric side effects, including hallucinations and delirium. Many of those Tamiflu side effect reports involved children and some resulted in fatalities.

Tamiflu, manufactured by Roche Laboratories, was approved by the FDA in 1999 for the treatment and prevention of flu in patients 1 year and older. The link between Tamiflu and psychiatric side effects was first reported in Japan. In Japanese patients under sixteen, four adverse events involved fatal falls, and one involved a leukemia patient who developed encephalitis. Also in Japan, there where two reports of deaths in young people aged 17 to 21, one involving a ?fatal accident with abnormal behavior? and another encephalitis death. In March 2007, the Japanese Tamiflu adverse event reports prompted that country?s drug regulatory agency to restrict the use of Tamiflu. Of the 48 million people treated with Tamiflu since its approval in 1999, the majority of users ? 35 million ? have been in Japan.

In 2005, the FDA convened an advisory panel to discuss the problems with Tamiflu, but the panel concluded the events likely weren?t related to Tamiflu. However, the panel recommended the agency keep monitoring the drug. On November 13, 2006, the FDA alerted doctors and parents to watch for signs of bizarre behavior in children treated with Tamiflu.

In November 2007, documents posted by FDA staff on the agency?s website said that there had been reports of 596 neuropsychiatric events, including 16 neuropsychiatric-related deaths, among children and adults taking Tamiflu. Among those reports, 75% came from Japan. In total, the FDA said, there were 25 deaths from all causes reported among Tamiflu users on a world-wide basis in patients younger than 21. That same month, the FDA convened another Tamiflu advisory panel, which recommended stronger warnings on the Tamiflu label regarding the drug?s possible neuropsychiatric side effects.

Based on the FDA Advisory Panel?s recommendations, the revised ?Precautions? section of the Tamiflu package insert will now advise of postmarketing reports (mostly from Japan) of delirium and abnormal behavior leading to injury, and in some cases resulting in fatal outcomes, in patients with influenza who were receiving Tamiflu. The package insert will also warn that these Tamiflu side effects were reported primarily among pediatric patients and often had an abrupt onset and rapid resolution. The label now warns health care providers to monitor influenza patients treated with Tamiflu for signs of abnormal behavior. If such side effects do present, the Tamiflu label says health care providers should weight the risks and benefits of continuing Tamiflu treatment.

This entry was posted on Tuesday, March 4th, 2008 at 8:14 am and is filed under Legal News, Pharmaceuticals.
*****
Note: Here's the link to the PDF:
http://www.fda.gov/medwatch/safety/2...miflu_DHCP.pdf

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[Snowy Owl]

Re: Bird Flu Medicine Toxic For Teens

04-16-2008, 07:20 PM
Shiloh
Senior Member

Join Date: Feb 2008
Posts: 886
An alarming side effect: Thoughts of suicide
Source: http://www.qctimes.com/articles/2008...e778348636.txt

An alarming side effect: Thoughts of suicide

By Melissa Healy / Los Angeles Times | Wednesday, April 16, 2008 |

As symptoms of depression go, there is none much clearer than having thoughts of suicide.

But a spate of recent announcements from federal health officials suggests a surprising new interpretation of suicidal fantasies and depression: Sometimes, sadness, anxiety and self-destructive thoughts are not symptoms but side effects.

Federal regulators have warned that a surprising array of drugs could play a role in spurring thoughts of self-destruction. Medicines that treat epilepsy, asthma and influenza are under suspicion, as is one that helps smokers kick the tobacco habit.

The Food and Drug Administration stresses that it has established no direct causal link between these medications and suicidal thoughts. But regulators acknowledge they have had one of two indicators of potential trouble in each case.

In some, a review of a drug's early clinical trials turned up increased rates of suicidal thinking among subjects taking the medicine. In others, the tip-off came when the FDA observed an uptick of reports that patients taking a medication developed symptoms of depression.

As a result, FDA officials and medical researchers are scouring data for clear signs that these drugs increase the risk of dangerous psychiatric symptoms. Moving forward, the agency will require developers of many new drugs to test for psychiatric side effects.

``We're trying to develop systematic strategies for looking ... in a more rigorous way,'' said Dr. Thomas Laughren, director of the FDA's division of psychiatry products. ``The difficulty is that we have such a primitive understanding of human behavior on a biological level ... it is hard to predict which compounds are going to have psychiatric effects.''

The recent rash of advisories comes four years after the FDA first suggested a connection. Prompted by reports that suggested children taking antidepressants were more likely to commit suicide, the agency in 2004 warned that antidepressants might increase the risk of suicidal fantasies and behaviors among children. That link is now in doubt, after recent studies showed a rise in youth suicide even as antidepressant use in that population has plummeted.

But the experience of coping with the anguished families of young suicide victims who took antidepressants has had a lasting effect on mental-health professionals, researchers and federal regulators. If early warning systems detect even a hint of psychiatric danger with a medication's use, government officials are inclined to alert first, study later.

``When they see a signal, even if they don't understand the genesis of that signal, that's a reasonable time to warn,'' said Dr. Robert Ward, a member of the FDA's pediatric advisory committee and professor of pediatric medicine and pharmacology at the University of Utah.

As it moves forward, the FDA hopes to detect such signals before a drug enters wide use.

One of the first drugs that will require testing for psychiatric side effects before it can be approved in the United States is rimonabant, an anti-obesity drug used in some 20 other countries. After early clinical trials suggested patients taking the drug had increased rates of depression and anxiety, an FDA advisory panel voted last June to recommend a delay in market approval pending further study.

The FDA has asked rimonabant's maker, the French pharmaceutical firm Sanofi-Aventis, to use a new yardstick to detect and measure suicidal side effects. Scientists long have known that many drugs used to treat symptoms below the neck enter the brain also and that the receptors and chemicals on which they work in organs such as the heart, blood vessels or liver are present in the brain as well, although they may have different functions there. That these drugs might have an incidental effect on mood, then, ``shouldn't be terribly surprising,'' Laughren said.

Still, some of the reports prompting advisories were wholly unexpected. In Japan, where antiviral medicines such as Tamiflu and Relenza are widely used to shorten the duration and ease the symptoms of influenza, last year's flu season raised serious alarms.

In the span of several months, two 14-year-old patients taking Tamiflu -- a boy and a girl -- fell to their death from high-rise apartment buildings in suspected suicides, and two 12-year-olds on the medication were injured after falling from buildings. Delirium, hallucinations and psychotic behavior caused one child taking the drug to bolt into traffic to his death.

In all, an FDA advisory panel was told last November, there have been 25 deaths and 365 cases of abnormal behavior in people younger than 21 who have taken Tamiflu since it was approved in 1999. Although regulators underscored that hallucinations and bizarre behavior can be a consequence of the high fevers and brain inflammation that can come with influenza, they acknowledged that they could not, without further scrutiny, rule out a link to Tamiflu.

``It came as a surprise to everyone,'' Ward said. ``First the antidepressants raised people's concerns, and then they started to find these unusual suicidal behaviors with Tamiflu. It caused people to ask, `Whoa, what is happening here?'''

Last month, the FDA notified physicians of the Japanese incidents (while noting that ``the contribution of Tamiflu to these events has not been established'') and urged close monitoring of young patients with influenza who might be taking an antiviral medication. In early April, GlaxoSmithKline, maker of the antiviral medication Relenza, voluntarily issued a similar notification to physicians.

March 27, the FDA went on to announce it was investigating a ``possible association between the use of Singulair,'' a pill used to treat asthma and allergies, and changes in mood and behavior, including suicidal thinking and suicide attempts. That warning came after the FDA's adverse-event monitoring system saw an uptick in reports of patients taking Singulair and experiencing symptoms of depression, including thoughts of self-destruction. Although this monitoring system relies on voluntary reports from patients and physicians and does not establish causal connections between a drug and a reported ``event,'' it is a key early detector of untoward side effects once a drug enters wide use.

Reports to the FDA also prompted a warning to health-care professionals Feb. 1 about Chantix, an anti-smoking drug approved in May 2006. As the medication gained a foothold among U.S. smokers, patients began telling physicians and the FDA of peculiar behavior, agitation, depressed mood and suicidal thoughts and actions.

By January, the FDA had concluded ``it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms'' and urged physicians to weigh that possibility when prescribing the drug and to carefully monitor patients who take it.

One recent warning emerged not from spontaneous reports by patients and doctors but from an internal FDA effort. Last year, after studies had shown an increase in suicidal thoughts and behavior among people taking certain drugs for epilepsy, the FDA conducted a broad review of clinical trials for 11 anti-convulsive drugs.

The result was a Jan. 31 alert informing physicians of an established link between the 11 drugs and suicidal thinking and actions. As a group, patients taking any of the 11 medications were twice as likely to experience suicidal thoughts and actions as those who took a dummy pill. The heightened risk of self-destructive symptoms was evident as early as one week into treatment and continued throughout the 24 weeks of study.

Although such reports of psychiatric side effects defy prediction, researchers said understanding the connection between mind and body should lead the way to better guesses at which drugs might unexpectedly darken a patient's mood, and why.

``With every passing day, we've learned so much that there's a strong connection'' between physical and mental health, said Dr. Husseini Manji, director of the Anxiety and Mood Disorders Program at the National Institute of Mental Health. ``When you're depressed, a lot of things in your body don't work well. But conversely, both medical illnesses and certain medications can markedly make you depressed.''

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