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Page: << Prev | 1 | 2 | 3 | Next >> "I wasn't surprised to see that they were trying to find a way to use it for patients who are getting chemotherapy for palliative care and not use it for patients for a curative intent, because of their concern of the tumor effects of the ESAs," Silver said.
Silver isn't sure, however, that the medications should be limited to palliative care. "Who makes the decision if it's curable or not? It's an interesting issue," Silver said. "I'm interested to see if this is going to pass muster in the FDA."
Silver also thinks that over the next four or five months, as the FDA considers the panel's recommendations, there will be changes. "They can't negate it all, but it will be interesting to see what comes out the other side," he said.
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In statements released this week, both companies that sell the drugs defended their safety, when used according to recommended dosages, for the treatment of chemotherapy-induced anemia.
And following the panel's action, Amgen issued the following statement: "Amgen takes very seriously the safety signals seen in recent trials where ESAs were used outside of the labeled indication. ... We are committed to working with the FDA to consider the input from the committee and to implement future label changes," said spokesman David Polk.
Thursday's meeting is the latest in a long string of FDA actions concerning the potential dangers of these drugs since their approval in the early 1990s.
This isn't the only group of patients using ESAs that concerns the FDA. In kidney patients, past research has found that if these drugs are used to raise hemoglobin levels above 12 grams per deciliter of blood, the risk of death increases.
The growing body of evidence led the FDA to have the drugs' manufacturers add a "black box" warning to the medications last November. The warning indicates that the medications should be used at the lowest possible doses to avoid risks such as blood clots, heart attacks, stroke, congestive heart failure, increased tumor growth and an increased risk of death. The FDA also noted the trials generally indicated an increased risk when blood levels were raised above 12 grams per deciliter.
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