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 FDA Information - July 20, 2008
| A U.S. Food and Drug Administration (FDA) advisory panel on Wednesday recommended the psoriasis drug Enbrel to be approved for pediatric use with moderate-to-severe forms of the skin disease. Seven panel members from the advisory committee voted in favor of recommending approval while five voted against and one abstained. The panel said the drug appears effective but expressed concerns about increased risks of malignancy and serious infections like tuberculosis | | The U.S. Food and Drug Administration (FDA) is warning consumers not to buy or use fraudulent cancer "treatments" available on the Internet that come in many forms, including pills, tonics, and creams and are sold under various names. The federal agency has sent letters warning more than two dozen companies to stop selling false products that claim to prevent or cure cancer. Medicinal products and devices intended to treat cancer must gain FDA approval before they are marketed, the agency said Tuesday | | The U.S. Food and Drug Administration is ordering manufacturers of antipsychotic drugs to include boxed warnings on the products after the agency found that the medications can increase the risk of death in some elderly patients. These medications reduce the psychotic symptoms of schizophrenia and usually allow the patient to function more effectively and appropriately. However, doctors frequently prescribe them to treat elderly patients with dementia | | The U.S. Food and Drug Administration on Friday said a drug from Johnson & Johnson appears effective at treating a severe skin disease, but warned that its extended use may raise the risk of cancer. Long-term use of ustekinumab may lead to increased risk of tumor development in psoriasis patients, the federal agency said on its website. The agency added that it still needs more long-term safety data to decide whether the drug increases the risk of cancer | | The U.S. Food and Drug Administration still hasn't announced the source of salmonella-tainted tomatoes that have sickened 228 people in 23 states. Although Florida has reported cases of salmonella outbreak, the FDA has declared tomatoes grown in Florida are safe and free from salmonella | |
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