WASHINGTON, Nov. 23, 2007

Flu Drugs Causing Bizarre Behavior?

FDA Wants Warnings For Tamiflu, Relenza For Young Kids As Studies Show Problems

  • A chemists takes out a package of Tamiflu at a pharmacy in Goeppingen, southern Germany. Now a panel is raising questions about the flu drug's safety for children. Photo

    A chemists takes out a package of Tamiflu at a pharmacy in Goeppingen, southern Germany. Now a panel is raising questions about the flu drug's safety for children.  (AP)

  • Interactive Fighting The Flu

    Health and vaccine information, photos and outbreak history

  • Photo Essay Pandemic Planning

    Preps for the 2006/07 flu season are a nationwide readiness test for bigger things.

(AP)  Government health regulators recommended adding label precautions about neurological problems 151; including hallucinations and convulsions - seen in children who have taken flu drugs made by Roche and GlaxoSmithKline.

The Food and Drug Administration on Friday released its safety review of Roche's Tamiflu and Glaxo's Relenza. Next week, an outside group of pediatric experts is scheduled to review the safety of several such drugs when used in children.

FDA began reviewing Tamiflu's safety in 2005 after receiving reports of children experiencing neurological problems, including hallucinations and convulsions.

Twenty-five patients under age 21 have died while taking the drug, most of them in Japan. Five deaths resulted from children "falling from windows or balconies or running into traffic."

There have been no child deaths connected with Relenza, but regulators said children taking the drug have shown similar neurological problems.

While FDA said it isn't clear whether the problems are directly related to the drugs, it recommends adding language about the possible side effects to labeling for physicians who prescribe Tamiflu and Relenza.

Besides being a drug side effect, the agency said the behaviors alternately could result from an unusual strain of flu or a rare genetic reaction to the drug.

Company representatives were not immediately available for comment.


© MMVII The Associated Press. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed.

Video and Galleries from Health

Add a Comment See all 20 Comments
by lawyertom1 November 23, 2007 2:26 PM PST
It is interesting that this article appears at the same time as one that notes that many, many drugs given to children have never been tested for their effect upon children, whose biology is different than adults. Also, though we humans are very much alike, there is enough difference in our genetic structure to expect that drugs will have a widely differential effect upon individuals within any given population. The lack of adequate testing and the failure to engage in post-approval monitoring are well known failings of our drug "regulatory" system.
Reply to this comment
by denn034 November 23, 2007 2:40 PM PST
Forget the "label precautions" and recall them. The FDA should''ve never approved the drugs to begin with.
Reply to this comment
by republic1776 November 23, 2007 3:29 PM PST
The FEDs should not be in the Drug Business to begin with.
Heaven forbid "Free Adults" in the Free World and Physicians making correct choices, lest the dumbing of America.

----------------------------------------------------
denn034 SAID:
"Forget the "label precautions" and recall them. The FDA should''''ve never approved the drugs to begin with. "

Reply to this comment
by yongamerica November 23, 2007 3:45 PM PST
Just think what scandals would be occurring if there wasn''t a Federal review process for medicines. Can you imagine what the drug industry would be like if it was given the as cavalier oversight as the toy industry? There''d be more calamity than there was in Willy Wonka''s candy factory.

One quote you''d hear at the pharmacy might be: How much antifreeze is in them there Chinese vitamins?
Reply to this comment
by smiley676 November 23, 2007 3:49 PM PST
If there wasn''t some federal oversight of the drug business we would still be buying and dying from potions created by every scam artist on the street.

They don''t always get it right, but it is the federal government''s job to protect the people. So, they should be involved.
Reply to this comment
by excoachken November 23, 2007 4:23 PM PST
Now I understand Britaney, Paris, Nicole and Jenna and Barbara.
Reply to this comment
by alphaa10-2009 November 23, 2007 4:58 PM PST
LawyerTom1 said, "The lack of adequate testing and the failure to engage in post-approval monitoring are well known failings of our drug "regulatory" system..."
---
Bush and his stealth proxy, Ron Paul, share the policy of "lessez faire" (leave alone) for government administration of such important matters as the FDA-- and it shows in that agency''s almost brain-dead neglect of American health and safety on far too many food and drug consumer issues.

Bush considers the FDA-- like FEMA and DHS-- to be a rest home for political cronies and a servant of his political backers. At FDA, a major policy objective is to make the pharmaceutical industry feel confortable.

In effect, the FDA is permanently out-to-lunch-- a lunch paid for by the major pharmaceuticals. Not surprisingly, FDA policies on drug development strongly favor the major drug corporations, not innovative but underfunded approaches from smaller enterprises.

Few Americans realize the FDA does not independently verify pharmaceutical industry data. FDA does not do significant parallel validation studies of its own.
Reply to this comment
by kaylag04 November 23, 2007 10:38 PM PST
Good Grief!
My grandmother was born in Idaho in 1900; a baby in the family died of polio, her father died of pneumonia in his early 40s, corrective lenses were like gold. Folks had lots of children, in part because one or more would certainly die.
Evil "big-medicine" and evil "big-pharm" have made the common killers (TB, cholera, polio,etc.) of 100 years ago practically unheard of, allowed premature babies to live, and have allowed victims of previously fatal diagnosis (various cancers, contraction of HIV)to not only survive, but live. For crying out loud - you can get examined, prescribed and pick up your glasses all at freakin'' Wal-Mart!
Is medical care too expensive? Probably. Are there problems with our regulatory practices concerning medications? Absolutely.
Are there a heck of a lot of folks around to complain today, that wouldn''t be without evil pharmaceutical companies and private medical research? For sure.
Reply to this comment
by republic1776 November 23, 2007 11:02 PM PST
FEMA''s purpose is to matain Government Control.
Unlike what most socialist and Democrats think...
They are not the Red Cross.
Reply to this comment
by alphaa10-2009 November 24, 2007 12:48 AM PST
ttinsly said, "There are herbal medicines out there that have been proven to work as well or better than other strong chemicals that make profits from their sales while adding on strong side effects...''
---
The pharmaceutical industry "sponsored" a study on echinacea which turned out not to favor the herb so strongly as other studies had suggested. Only later was it revealed the industry study failed to extract properly the phytochemical compounds under study.

In addition, the study''s statistical method still left echinacea "almost" significant-- meaning the study numbers easily could have gone the other way, had the plant compound been rendered at full strength. Apparently, Big Pharma still has much to learn from herbal medicine.

Herbs are the oldest drugs, and have the greatest mass of field trial data on record, with an increasing proportion of modern experimental findings. In a subtle bow to herbs'' preeminence in medicine through history, the major pharmaceuticals still scour the earth for promising leads to plant compounds to be synthesized, renamed and marketed.

This approach offers benefits when drug companies learn from nature. But the ultimate ambition of Big Pharma is to "improve" on nature. That direction involves both the lab and legions of paying guinea pigs, sometimes called patients, who use approved experimental compounds literally at their own risk. That is why the quality and integrity of FDA administration is so much at issue.
Reply to this comment
by alphaa10-2009 November 24, 2007 1:03 AM PST
KaylaG04 said, "Are there a heck of a lot of folks around to complain today, that wouldn''''t be without evil pharmaceutical companies and private medical research? For sure."
---
Study the complaints about pharmaceutics, and you quickly will surmise where the evil lies. Evil is not in the science pharmaceuticals exploit, but the entirely unnecessary human corruption attending any market monopoly where power incites greed.

"Power corrupts, and absolute power corrupts absolutely."

For sure.
Reply to this comment
by alphaa10-2009 November 24, 2007 1:07 AM PST
republic1776 said, "FEMA''''s purpose is to matain Government Control. Unlike what most socialist and Democrats think... They are not the Red Cross."
---
In recent years, it has become clear even the Red Cross is not the Red Cross.

But you are the government in a democracy. And this has nothing to do with whether you think, or do not think so.
Reply to this comment
by drivelphobe November 24, 2007 9:55 AM PST
The modern medicine machine at work, pumping suspecting, frightened individuals full of side=effect ridden treatments for conditions that are naturally taken care of by our own bodies. The TV ad made this look like a coco puff or a candy! How can a kid refuse?

Don''t listen to the doctors hype about all the BS. Go to the doctor when you are injured or are sick. Don''t go because he/she schedules you for a check up. There is no such thing as preventive medicine. The real term is revenue enhancement.
Reply to this comment
by baptox November 25, 2007 12:31 AM PST
I agree with kaylaGo4...If you want to experience what life was like before vaccines were available, visit an old cemetery and look at family graves prior to and just after the turn of the last century.

It was not uncommon for entire families to be wiped out by an epidemic of flu, or TB, or many other communicable diseases for which we now have some protection.

Another way to experience how fortunate we are in the West, in regards to preventive healthcare, is to visit a poor country in which vaccinations are a luxury and in which a good number of women and children die in childbirth.
Reply to this comment
by jetranger7 November 25, 2007 3:07 AM PST
WELL IF THIS DRUG IS MAKING PEOPLE ACT STRANGE, THE ENTIRE WHITE HOUSE STAFF MUST BE TAKING IT !!!!
Reply to this comment
by rowdytexan2 November 25, 2007 9:05 AM PST
Too many people I know that got the flu and pneumonia shots are sicker than dogs as we speak.

The last time I took a flu shot, I ached for a month after. Doc said impossible! But he couldn''t explain why I was achy and felt terrible.

Why take something that is likely to make you sick anyway? This is pharmaceutical claptrap. They''re making millions.

If you get flu symptoms, that''s the time to go get treatment.

Reply to this comment
by limestoneman November 25, 2007 12:57 PM PST
Haha, 1692 all over again.
Reply to this comment
by harp1963 November 25, 2007 3:35 PM PST
I work in the pharmaceutical industry and regularly read the outserts that come along with the huge variety of medicines we produce. After reading the side effects of most of this stuff, I''d rather have the original problem than the side effects.

Eat right, exercise, get a good nights sleep, and go to the Church of whatever denomination you belong to every week. That will solve most of your health problems.
Reply to this comment
by carlylaine November 26, 2007 8:44 AM PST
drivelphobe

I agree with you 100% and I live in this manner. I hate doctors. They have the mistaken idea that they are our gods on earth.

I''d rather die from my own choices than to die under the influence of a doctor.
Reply to this comment
by tngreen November 26, 2007 1:27 PM PST
WELL IF THIS DRUG IS MAKING PEOPLE ACT STRANGE, THE ENTIRE WHITE HOUSE STAFF MUST BE TAKING IT !!!!

Posted by JetRanger7 at 03:07 AM : Nov 25, 2007
_____________

It''s just too bad it''s not making them leap out of windows or run into traffic!
Reply to this comment
See all 20 Comments
  • MOST POPULAR
  • Viewed
  • Commented
Latest News
Featured Blogs