Word: fda
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Dates: during 2000-2009
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...patients in three ongoing Celebrex trials have been followed for several years without any signs of cardiovascular effects. Bextra, also from Pfizer, hasn't been tested as long, but so far the data look good. Two more COX-2 inhibitors, Arcoxia (from Merck) and Prexige (from Novartis), are awaiting FDA approval. "Obviously, we now have to look more carefully at the other members of the class," says Dr. Steven Nissen, a cardiologist at the Cleveland Clinic who voiced his concerns about Vioxx several years...
...first hint that there might be a problem with Vioxx surfaced in 2000, just a year after the drug won FDA approval. A study that compared Vioxx with naproxen (the active ingredient in Aleve) showed that Vioxx cut gastrointestinal problems in half but increased the risk of heart attack from 0.1% to 0.4%. Those results were ambiguous, though. Was Vioxx causing the heart attacks, or was naproxen protecting the heart? Few experts fault Merck for continuing to market Vioxx on the basis of that study alone...
...took Vioxx for more than 18 months had a small but significant risk of suffering a heart attack or stroke--1.5% for Vioxx users, compared with 0.75% for the placebo group. After a weekend spent double-checking the safety panel's data and conclusions, Merck officials told the FDA that although there was no increase in the number of deaths among those who took the drug, the company was voluntarily recalling its drug...
...important to continue to monitor the safety of a medication even after it has been approved. Most clinical studies involve only a few thousand patients and may last less than a year--enough to catch major problems. But once a drug passes muster with the FDA, it is often prescribed for millions of people. That's when more subtle side effects may emerge. Unfortunately, so-called postapproval surveillance still tends to get short shrift...
...better control of their disease. Exubera, already being considered for sale in Europe, would, if approved, become the first inhaled insulin for diabetics in the U.S. and would be a welcome option for Type 2 patients who may need insulin boosts before meals. One issue that the FDA will be watching carefully is how the insulin powder affects the lungs and whether it causes breathing problems, tumor growth or fibrosis. So far, studies show that after a few years of treatment patients exhibited slightly decreased lung function on certain breathing tests, although they did not report any shortness of breath...