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NIH halts use of COX-2 inhibitor in large cancer prevention trial
The National Institutes of Health (NIH) announced today that it has suspended the use of COX-2 inhibitor celecoxib (Celebrex™ Pfizer, Inc.) for all participants in a large colorectal cancer prevention clinical trial conducted by the National Cancer Institute (NCI). The study, called the Adenoma Prevention with Celecoxib (APC) trial, was stopped because analysis by an independent Data Safety and Monitoring Board (DSMB) showed a 2.5-fold increased risk of major fatal and non-fatal cardiovascular events for participants taking the drug compared to those on a placebo. more
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FDA statement on the halting of a clinical trial of the Cox-2 inhibitor Celebrex
Read the official FDA statement released after a clinical trial of the Cox-2 inhibitor Celebrex (celecoxib) was halted. more
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FDA alert for practitioners: Celebrex (celecoxib)
Based on emerging information, including preliminary reports from one of several long term National Institutes of Health (NIH) prevention studies, the risk of cardiovascular events (composite endpoint including MI, CVA and death) may be increased in patients receiving Celebrex. FDA will be analyzing all available information from these studies to determine whether additional regulatory action is needed. more
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Celebrex capsules - FDA Patient information sheet
This is a summary of the most important information about Celebrex. For details, it is important for the patient to talk to their healthcare provider. more
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New warning for ADHD drug, Strattera
The Food and Drug Administration (FDA) is advising health care professionals about a new warning for Strattera, a drug approved for attention deficit hyperactivity disorder (ADHD) in adults and children. The labeling is being updated with a bolded warning about the potential for severe liver injury following two reports (a teenager and an adult) in patients who had been treated with Strattera for several months, both of whom recovered. more
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FDA statement on Iressa
The Food and Drug Administration (FDA) learned from AstraZeneca that a large clinical trial comparing Iressa (gefitinib) with placebo in patients with non-small cell lung cancer who had failed other courses of cancer therapy showed no survival benefit from taking Iressa. more
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Yo-yo diet redistributes toxins in body tissue; Olestra+caloric cut boosts toxic excretion
Perhaps Ukrainian Viktor Yushchenko should try olestra to get rid of dioxin. It's worked before. A new study shows how diet affects chlorinated hydrocarbons trapped in body fat and how olestra raises their excretion rate up to 30-fold. more
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