FDA Approves Pediatric Use of Chemical Poisoning Treatment

The Food and Drug Administration has approved the pediatric use of Protopam Chloride (pralidoxime chloride), a drug used to treat poisoning by organophosphate pesticides and chemicals (e.g., nerve agents). The drug is approved to be administered either by intravenous (IV) or intramuscular (IM) injections.
"We know this drug has been widely used for many years to treat poisoning in pediatric patients in emergency situations," said Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. "Improving the drug's label with new dosing information for children will give health care professionals better guidance on how to use this drug safely and effectively."
Organophosphate pesticides are typically used in the farm setting and by professional exterminators. A person poisoned with organophosphate pesticides or chemicals (e.g., nerve agents) can have mild symptoms, such as a runny nose, teary eyes, or vomiting, to more serious symptoms such as difficulty breathing, weakness and convulsions. When chemical poisoning is suspected, medical attention should be sought immediately and the local poison control center should be contacted by dialing 800-222-1222, nationwide.
"It can be difficult to use IV drugs in children, particularly in emergency situations, so having the new option of IM injection may help health care professionals use this medicine quickly and accurately," said Dianne Murphy, M.D., director of the FDA's Office of Pediatric Therapeutics.
Protopam Chloride was approved by the FDA in 1964 to treat various types of pesticide and chemical poisoning in adults. The drug works as an antidote to pesticides and chemicals of the organophosphate class by slowing the attachment of the chemical to nerve endings.
Adverse reactions that have been reported in pediatric and adult use of the drug include: blurred vision, double vision, dizziness, headache, drowsiness, nausea, difficulty breathing, increased heart rate and increased blood pressure.
Protopam Chloride is made by Baxter Healthcare Corp., Deerfield, Ill.



*) From : Occupational Health & Safety Magazine

NIH to resume funding stem cell research for now

WASHINGTON – The government said Friday it's back in the business of funding embryonic stem cell research — at least for now — after an appeals court temporarily lifted a judge's ban.
The National Institutes of Health said it is resuming its own research and will again evaluate applications from scientists who are seeking taxpayer money to do the work, a process that has been frozen since late last month.
An appeals court on Thursday temporarily stayed a judge's preliminary order barring that funding until it could hear full arguments in the next few weeks.
In the meantime, the NIH said it is lifting its suspension of all grants and contracts involving use of the cells.
"We are pleased with the court's interim ruling, which will allow promising stem cell research to continue" while the court battle is waged, said the NIH's statement.
Scientists who already had received NIH grants had been told to continue working until their dollars ran out, but that 22 projects due to get yearly checks in September would have to find other money.
Now the question is whether the NIH will finish the reviews required for those projects during what could be only a temporary reprieve. No matter what, the case is certain to be bouncing around the court system for many months before there's a final resolution.
"We believe it's a shame that they would rush to push funding of embryonic stem cell research, and a waste of taxpayer money," said Steven H. Aden, senior legal counsel for the Alliance Defense Fund, which is involved with the lawsuit that challenged the government funding.
Embryonic stem cells are master cells that can turn into any tissue of the body, and researchers hope one day to harness that power in ways that cure spinal cord injuries, Parkinson's disease and other ailments.
Culling them from embryos left over after fertility treatment kills a days-old embryo. A 1996 law prohibits the use of taxpayer dollars in work that harms an embryo, so batches have been culled using private money. But those batches can reproduce in lab dishes indefinitely, and government policies say using taxpayer dollars to work with the already created batches is permissible.
Last month, U.S. District Court Judge Royce Lamberth disagreed, in a sharply worded preliminary injunction in which he argued that the research violated the intent of the 1996 law. Lamberth left little doubt that he is inclined to issue a final order barring funding, which will set off a new round of appeals.
Amid the back-and-forth, researchers are struggling to figure out how to secure long-running experiments.
"I take no solace in the ruling because so much uncertainty remains about the future of human stem cell research," said Dr. George Daley, a leading stem cell researcher at Children's Hospital Boston. "I won't rest peacefully until there is a clear and unambiguous vote of support from the Congress for this vital research."
Congress twice passed legislation specifically calling for tax-funded stem cell research, which President George W. Bush vetoed. Some Democrats are considering whether to try the legislation again.
The lawsuit was filed by two scientists who argued that President Barack Obama's expansion of the number of stem cell lines available for government funding jeopardized their ability to win grants to research adult stem cells — ones that have already matured to create specific types of tissues — because of extra competition.
Many scientists believe the more flexible embryonic cells have more promise, but lots of work is under way with both kinds. The NIH's estimated budget for next year would spend more than three times as much on research for adult stem cells as embryonic ones, said Patrick Clemins of the American Association for the Advancement of Science.



By LAURAN NEERGAARD, AP Medical Writer Lauran Neergaard, Ap Medical Writer – Fri Sep 10, 1:08 pm ET

rubella

The Columbia Encyclopedia, Sixth Edition | The Columbia Encyclopedia, Sixth Edition. Copyright 2008 Columbia University Press. (Hide copyright information) Copyright

rubella or German measles, acute infectious disease of children and young adults. It is caused by a filterable virus that is spread by droplet spray from the respiratory tract of an infected individual. Rubella is a much milder infection than rubeola (measles) and the rash, appearing after an incubation period of two to three weeks, rarely lasts more than three days. The lymph nodes behind the ears become tender and swollen, but otherwise German measles is almost always uncomplicated. However, during the first trimester of pregnancy it is associated with an increased risk of congenital damage to the fetus, producing stillbirths, abortion, low birth weight, and such malformations as cardiac defects, eye defects (especially cataracts), and mental retardation. During the first 16 weeks of pregnancy the infection has been estimated to carry a risk of fetal damage of between 30% and 35%. Pregnant women who have been exposed to rubella are given gamma globulin in an effort to prevent the disease. Research to develop a vaccine that would confer immunity was spurred by an epidemic of rubella in 1964 and the evidently related rise in the number of birth deformities. A live attenuated vaccine has been developed and is given to girls from 15 months to puberty and often to boys as well. Approximately 13% to 15% of women develop acute arthitis from vaccination. Before the vaccine can be administered to an adult woman it must be determined that she is not pregnant, and the test for the presence of rubella antibodies (which would indicate immunity to the disease from previous exposure) is given. Birth control should be practiced for at least three months after receiving the vaccine.