FDA Review Recommends Warnings on Kids' Flu Drugs
Reports of neurological problems in children taking the flu drugs Tamiflu and Relenza mean the medicines need a warning label on their packaging, according to a U.S. Food and Drug Administration safety review released Friday.
According to the Associated Press, the safety review follows 25 deaths among Tamiflu users under the age of 21, most of them occurring in Japan. In five cases, children fell from windows or balconies or ran into traffic, the AP said.
The FDA began its review in 2005 after receiving reports of children experiencing hallucinations, convulsions and other neurological problems while on Tamiflu.
Data from the review will be considered by a special panel of outside experts that will meet on Tuesday to mull the agency's proposed label changes. The FDA is not required to follow the advice of its advisory panels, but usually does.
According to the AP, there have so far been no child deaths linked to Relenza, but regulators say some children taking the drug have shown similar neurological symptoms.
Neurological side effects may come from a rare strain of the flu, or a rare genetic reaction to the flu drugs, according to the FDA.
Relenza's current label makes no mention of neurological problems. Tamiflu's labeling currently mentions the potential for self-injury or delirium, but does not say these incidents could prove fatal. The proposed labeling change would add that warning to Tamiflu, the AP said.
In a statement, Tamiflu's maker, Swiss-based Roche, said there's no hard evidence linking the drug to neurological trouble, which the company says can also be caused by the flu. However, referring to a proposed label change, Roche said it is "open to that consideration."
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Leg Vein Clots Boost Heart Attack, Stroke Risks
Patients with clots in the veins of the legs, known as deep vein thrombosis (DVT), face higher risks for heart attack or stroke in the year after a clot, according to a study in the Nov. 24 issue of The Lancet.
These clots have been noted in passengers on long-haul flights and have been dubbed "economy class syndrome," although they do occur in other settings.
In the study, researchers at Aarhus University Hospital, Denmark, tracked one-year outcomes for over 25,000 people with DVT, almost 17,000 people with pulmonary embolism (clots that travel to the lung), and close to 164,000 healthy controls.
They found that DVT boosted the 12-month risk of heart attack and stroke by 60 and 119 percent, respectively, compared to controls. Pulmonary embolism boosted the odds for heart attack over the following year by more than two-and-a-half times compared to controls, while nearly tripling a patent's risk of stroke.
The increase in risk was roughly equivalent to that of conventional cardiovascular risk factors such as diabetes and smoking, the team noted.
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Rotavirus Vaccine Could Help Prevent Child Diarrhea
A new vaccine against rotavirus -- a gastroenteritis bug responsible for sometimes lethal diarrhea in infants and young children -- shows promise in a new trial and might help save children's lives, experts say.
A team from the University of Tampere, Finland, tested the RIX4414 vaccine in almost 4,000 infants six to 14 weeks of age, living in six European countries.
After receiving two doses, children showed more than 90 percent protection against severe gastroenteritis over two seasons. The shot was also 96 percent effective in preventing illness requiring hospitalization, the researchers report in the Nov. 24 issue of The Lancet.
In an accompanying editorial, experts caution that diverse strains of rotavirus circulate in Africa and Asia, so no global recommendations on the vaccine's use can be made until it is tested in those populations.
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Britain Would Vaccinate All Against Pandemic Flu
U.K. health officials on Thursday announced they are planning to stockpile enough pandemic flu vaccine to protect the entire population, the Associated Press reported.
A flu pandemic was "one of the most severe risks" facing Britain, Health Secretary Alan Johnson told lawmakers. He said he had signed an agreement that would assure the delivery of enough vaccine to protect every citizen.
Experts can only formulate a vaccine once the strain of the pandemic virus had been identified, however. Health officials said it remains impossible to predict when a pandemic might strike or how widespread it might be.
According to an unnamed department of health spokeswoman, the last global flu epidemic occurred in 1968 and killed over one million people worldwide. She told the AP that "we don't believe an influenza [pandemic] is imminent."
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Common Gene May Protect Against Cancer
Two variants of the B-MYB gene, which is carried by up to half of the world's people, may shield humans against cancer, the BBC reported Wednesday.
Scientists compared variants of B-MYB found in more than 400 patients with either colon cancer, a brain tumor called neuroblastoma, or chronic myeloid leukemia, to variants found in 230 people without cancer.
Reporting in the journal Oncogene, the team found that patients with malignancies were half as likely to carry the protective B-MYB gene variants as people without cancer.
"People who carry these gene variants might well be protected against cancer," researcher Dr. Arturo Sala of the Institute of Child Health told the BBC. Up to 50 percent of people in Africa appear to carry the protective variant, and perhaps slightly fewer in North America and Europe.
"Discovering exactly how it might protect against [cancer] could allow researchers to explore new avenues of cancer prevention," Henry Scowcroft, senior scientific information officer at Cancer Research UK, told the BBC.
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