Cold meds send 7000 kids to hospitals
Wed, 30 Jan 2008 02:26:58 GMTBy MIKE STOBBE, AP Medical Writer
ATLANTA - Cough and cold medicines send about 7,000 children to hospital emergency rooms each year, the U.S. government said Monday in its first national estimate of the problem.
About two-thirds of the cases were children who took the medicines unsupervised. However, about one-quarter involved cases in which parents gave the proper dosage and an allergic reaction or some other problem developed, the study by the U.S. Centers for Disease Control and Prevention reported.
The study included both over-the-counter and prescription medicines. It comes less than two weeks after the U.S. Food and Drug Administration warned parents that over-the-counter cough and cold medicines are too dangerous for children younger than 2.
The study's findings about the proportion of properly dosed kids who end up in the ER is likely to contribute to FDA discussions about recommendations of cough and cold medicines in the 2-to-6 age group, CDC officials said.
CDC researchers gathered case reports of children 11 and under who had taken cough and cold medications and wound up in 63 hospitals studied in 2004 and 2005. They used that number to come up with the national estimate.
About 1,600 of the estimated 7,100 children are under 2, so the FDA's guidance — if followed — should reduce such ER cases by 23 percent.
Nearly two-thirds of the cases involved kids ages 2 to 5, the CDC found.
"The main message is no medication left in the hands of a 3-year-old is safe," said the CDC's Dr. Melissa Schaefer.
Many of the ER case reports were not specific about symptoms, and the researchers did not follow cases through to conclusion. So they did not know if — or how many — deaths resulted, said Schaefer, an epidemiologist who was the study's lead author.
For the children whose symptoms were reported, allergic reactions like hives and itching were most common, and neurological symptoms like drowsiness and unsteady walking were next, she said.
Most of the medicines involved were liquid combinations of cough and cold treatments, CDC researchers said.
Of the children who reportedly got the right dose of medication, about a third were younger than 2, but more than half were ages 6 to 11, the study found.
Some children suffer side effects from medications, so those results aren't necessarily unexpected, Schaefer said. The FDA will have to balance data like this against the medicines' benefits and other factors, she added.
"What we gave them was a piece of the puzzle," she said.
Parents should not encourage children to take medicine by telling them it's candy, and parents should also avoid taking adult medications in front of kids, CDC officials said.
The study tells a story of the misuse of medications, said Linda Suydam, president of the Consumer Healthcare Products Association, a trade group that represents manufacturers and distributors of over-the-counter medicines.
"These medicines are safe when used as directed, and this government review underscores the importance of educating consumers — especially those with small children — on the safe use and safekeeping of medicine," Suydam said, in a prepared statement.
The study was published online Monday. It will appear in the April issue of Pediatrics, a journal of the American Academy of Pediatrics.
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On the Net:
CDC Web page on medication safety:
http://www.cdc.gov/ncipc/factsheets/poisonprevention.htm
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New flu vaccine may not need needles
Tue, 29 Jan 2008 22:14:19 GMTBy RANDOLPH E. SCHMID, AP Science Writer
WASHINGTON - Relief may be on the way for all those youngsters trembling at the thought of another needle jab. One day the flu vaccine may simply be placed under the tongue.
Korean researchers say the new vaccine worked in mice, avoiding not only the painful prick but also the discomfort some people feel from the inhaled vaccine.
The team led by Dr. Mi-Na Kweon of the International Vaccine Institute in Seoul reported their findings in Monday's online edition of Proceedings of the National Academy of Sciences.
Better ways of delivering vaccine have long been under study, ranging from orally to inhaled, but all seem to have drawbacks.
Now, Kweon and colleagues say, two doses of influenza vaccine under the tongue of mice primed the animals' immune system to fight off what would otherwise have been a deadly dose of flu.
Next, they are turning their attention to people, to see if the under-the-tongue vaccine also prompts a strong immune response.
Placing a couple of drops of liquid under the tongue gets the vaccine directly to mucus membranes and prompts a response both in mucus tissues throughout the body as well as in the immune system itself, the researchers said.
"These studies provide a basis for further human testing of this alternative form of needle-free vaccination. Aside from its convenience, sublingual vaccination appears to disseminate immunity to a broader range of organs than the classical routes of injecting or ingesting vaccines," said Dr. Cecil Czerkinsky, deputy director-general for laboratory science at the Institute.
"If these findings are replicated in humans, they could pave the way for the development of a new generation of vaccines that could be used for mass vaccination against respiratory infections, including the pandemic avian-human influenza viruses," he said in a statement.
Several research efforts applying vaccine to mucus membranes have been tried, seeking to avoid both the needle sticks that people dislike and the harsh environment of the digestive system that can damage or destroy a vaccine. Studies of under-the-tongue of other medicines have also been done.
Dr. William Schaffner of Vanderbilt University noted that recent flu studies have involved nasal sprays.
However, he said while he had expected people to be averse to needles, he was surprised to discover that "many people are averse to people messing with their nose ... so there are limitations to nasal spray."
So for researchers looking for another means of doing this, "just a drop under the tongue at least will protect mice ... that's a very exciting and promising line of investigation," said Schaffner, who was not part of the research team.
And, he added, "if we were faced with a pandemic, the easier and more acceptable we can make the distribution of the vaccine the more rapidly we can protect a proportion of population."
Kweon also said in mouse studies there is a theoretical possibility of a nasal spray reaching the central nervous system, which would not happen with the under-the-tongue vaccine.
The under-the-tongue vaccine worked whether it was a live or inactivated virus, Kweon reported. And, she added, it could also be flavored to make it more acceptable.
The research was funded by the governments of the Republic of Korea, Sweden and Kuwait.
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On the Net:
Proceedings of the National Academy of Sciences: http://www.pnas.org
International Vaccine Institute: http://www.ivi.int
New treatment can clear brain clots
Tue, 29 Jan 2008 23:01:25 GMTBy LAURAN NEERGAARD, AP Medical Writer
WASHINGTON - It's a tiny vacuum cleaner for the brain: A new treatment for stroke victims promises to suction out clogged arteries in hopes of stopping the brain attack before it does permanent harm.
Called Penumbra, the newly approved device is the latest in a series of inside-the-artery attempts to boost recovery from stroke, the nation's No. 3 killer.
Now the question is how to determine which patients are good candidates — because, illogical as it may sound, unclogging isn't always the best option.
"Is the patient at a stage of stroke where you're going to hurt them by pulling a clot out, or show benefit?" asks Dr. Walter Koroshetz of the National Institutes of Health. "It's good we have devices. Now we have to learn how to use them."
More than 700,000 Americans suffer a stroke each year, and more than 150,000 of them die. Survivors often face serious disability.
Most strokes occur when blood vessels feeding the brain become blocked, starving delicate brain cells of oxygen until they die. For those, the clot-busting drug TPA can mean the difference between permanent brain injury or recovery — but only if patients receive intravenous TPA within three hours of the first symptoms.
Yet fewer than 5 percent of stroke sufferers get TPA, because they don't get specialized care in time. And of those treated, it only helps about 30 percent, because the clot is often too big or tough for TPA to bust.
Enter Penumbra, an option for patients who miss out on early care — it can be tried up to eight hours after a stroke strikes — or if standard TPA treatment fails.
Specialists thread a tiny tube inside a blood vessel at the groin and push it up the body and into the brain until it reaches the clog. Just like a vacuum cleaner, it sucks up the clot bit by bit to restore blood flow.
For the right patient, Penumbra can produce dramatic help, says Dr. Demetrius Lopes of Chicago's Rush University Medical Center, one of two dozen hospitals that tested the device in 125 severe stroke patients.
He points to 45-year-old Aretha Streeter, whose left side remained paralyzed almost an hour after a big dose of TPA. Lopes scanned her brain and spotted a key artery completely blocked. She agreed to the Penumbra experiment, and started moving as Lopes suctioned out the clot. Streeter was walking the next day, and was left with weakness in her arm instead of paralysis.
The study's full results will be presented next month at a meeting of the American Stroke Association.
But the device vacuumed out clots well enough to earn California-based Penumbra Inc. a surprise speedy approval from the Food and Drug Administration in late December. Rush's Lopes says it caused few serious side effects, and that about 42 percent of successfully treated patients showed significant recovery a month later.
Penumbra isn't the only mechanical clot-buster. Doctors also can try threading a corkscrew-shaped wire called the Merci Retriever through the clot and tugging it out. Researchers also are experimenting with dripping TPA directly on the clot instead of the old IV method, and even beaming the clog with ultrasound waves for an extra jolt.
Here's the rub: Unclogging sometimes does more harm than good in bad strokes, says Koroshetz, deputy director of NIH's National Institute for Neurological Disorders and Stroke.
When the dam is broken and blood rushes into oxygen-deprived brain tissue, it sometimes triggers swelling or a brain hemorrhage. Either can kill.
So treatment is a balancing act: Using brain scans to estimate if the stroke already has killed all the brain tissue it's going to, or if enough still could be salvaged that it's worth the risk of this injury, Koroshetz explains.
"Your ability to succeed with taking the clot out depends on what's going on in the brain," he cautions.
The NIH is funding a 900-patient study comparing standard therapy with different inside-the-artery treatments — the TPA drip, ultrasound, and the Merci Retriever — to tell if and how they should be used. Researchers will decide soon whether to include the new Penumbra device in that study.
What treatment to pick is a doctor's dilemma. For patients, the message is clear: Call 911 as soon as you experience stroke symptoms. They include sudden numbness or weakness, especially on one side; confusion, trouble speaking or walking; or an abrupt terrible headache.
Aretha Streeter didn't realize the worst headache of her life meant a stroke had begun, although her mother had died of a stroke and her sister had survived one. Fortunately she went on to her job as a hospital technician at Rush, so care was just steps away when she slumped over.
"It came and went so fast," Streeter says in amazement at both the speed of the stroke, and its treatment.
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EDITOR's NOTE — Lauran Neergaard covers health and medical issues for The Associated Press in Washington.
