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FDA Wants More Time to Study Cold Meds for Kids

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THURSDAY, Oct. 2 (HealthDay News) -- The U.S. Food and Drug Administration will take its time considering whether to ban over-the-counter cold medicines for children, a top agency official said Thursday at a public hearing on the matter.

Dr. John Jenkins, who heads the FDA's Office of New Drugs, said the agency needed to get more data on whether "OTC" medicines are safe and effective for children between 2 and 6 years old before taking any action, the Associated Press reported.


     
     
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Cold Meds for Kids Back in the Spotlight

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THURSDAY, Oct. 2 (HealthDay News) -- After recommending earlier this year that children under the age of 2 not receive over-the-counter cold medicines, the U.S. Food and Drug Administration on Thursday is meeting with the public to help answer an even more important question: Should kids' cold medicines remain "OTC" at all?

The issue is not a new one for regulatory bodies or the public.


     
     
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Many Trial Reports on FDA-Approved Drugs Go Unpublished

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TUESDAY, Sept. 23 (HealthDay News) -- More than half of all supporting clinical trials for U.S. Food and Drug Administration-approved drugs remain unpublished five years after permission has been given to sell the drugs in the United States, say University of California, San Francisco researchers.

They combed the medical literature to determine the publication status of all 909 clinical trials that supported the 90 new drug applications approved by the FDA between 1998 and 2000.


     
     
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Plastic Chemical Tied to Heart Disease and Diabetes

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TUESDAY, Sept. 17 (HealthDay News) -- Bisphenol A (BPA), a chemical found in plastics that include baby bottles and packaging for food and beverages, may put people at risk for heart disease and type 2 diabetes, a new study concludes.

Adding to the controversy surrounding this ubiquitous chemical, this study fuels the fears of those who want it banned. However, the U.S. Food and Drug Administration said in April that BPA was "safe and that exposure levels to BPA from food contact materials, including for infants and children, are below those that may cause health effects."


     
     
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Keppra XR Approved for Partial-Onset Seizures

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MONDAY, Sept. 15 (HealthDay News) -- The U.S. Food and Drug Administration has approved an extended release form of Keppra (levetiracetam) as an add-on treatment for people with epileptic seizures aged 16 and older, Belgian drug maker UCB said Monday.

"While many people with epilepsy are successfully treated with one or more of the currently available anti-epileptic drugs, a significant percentage still live with uncontrolled seizures or intolerable side effects," the company said in a news release.


     
     
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'Abuse-Resistant' Form of OxyContin May Be Near

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THURSDAY, Sept. 11 (HealthDay News) -- Researchers say they've developed an "abuse-resistant" formulation of the widely prescribed opioid pain medication OxyContin.

The U.S. Food and Drug Administration has granted Remoxy priority review, meaning that action could come as soon as early December, said Dr. Nadav Friedman, chief operating officer of Pain Therapeutics Inc., which developed Remoxy.


     
     
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New Test Identifies Heart Transplant Rejection

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WEDNESDAY, Aug. 27 (HealthDay News) -- The U.S. Food and Drug Administration has approved AlloMap, a non-invasive test that helps doctors identify heart transplant recipients who are rejecting the new organ.

The test monitors the genetic activity of a transplant recipient's white blood cells, the immune system's primary defense against viruses, bacteria and other germs, the FDA said in a news release.


     
     
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'Ayurvedic' Medicines May Contain Lead, Mercury or Arsenic

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TUESDAY, Aug. 26 (HealthDay News) -- About one in five ayurvedic medicine products purchased on the Internet contain significant levels of lead, mercury or arsenic, a new study finds.


     
     
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A Hope: Contaminant-Free Synthetic Heparin

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MONDAY, Aug. 18 (HealthDay News) -- Robert J. Linhardt is a chemist with a dream: making the blood-thinner heparin by the bucketful without using animal tissue.

It's a dream that has taken on urgency this year, as the U.S. Food and Drug Administration attributed more than 80 American deaths and hundreds of illnesses to contaminated heparin from the conventional source -- pig intestines processed in China.


     
     
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First Treatment Sanctioned for Chorea in Huntington's Patients

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FRIDAY, Aug. 15 (HealthDay News) -- Xenazine (tetrabenazine) has been approved by the U.S. Food and Drug Administration as the first drug to treat chorea, the jerky involuntary movement that occurs in people with Huntington's disease.

It's the first FDA-approved treatment of any symptom of Huntington's, an inherited disorder that affects about 30,000 people in the United States, the agency said Friday in a news release. Another 200,000 people are at risk of developing the rare neurologic disease. People who develop Huntington's typically start to have symptoms between ages 30 and 50.