AVANDIA KO en UK...
Ahora en EU...
Ver...y en USA...?
Solo restringen...Por qué?
The reasoning behinnd Avandia´s U.S. stay of execution.
The FDA also says it wants to keep Avandia on the market because patients already taking it might not want to switch drugs mid-regimen. The other reason is that some patients might benefit from regulating their blood sugar with that class of drug, and be unable to tolerate Actos. Given the extensive safety warnings tacked onto Avandia now, anyone else who takes it would have to (or as the FDA believes, may have no choice but to) play Russian roulette with their meds.
For the EU, the sheer risks of the drug outweigh the benefits. Lawsuits against GSK allege that tens of thousands of heart attacks and deaths stem from use of Avandia. That may be why the EMA banned the drug outright, and required that it be pulled from the market.
The one-two punch from the FDA and EMA are probably the last of a long series of image and revenue-crippling blows to Avandia. The first came in 2007, when Dr. Steven Nissan and his colleague sorted through a study conducted by GSK on Avandia's safety, and found that the drug significantly increased a patient's risk for heart disease. Then the FDA called an advisory panel to review Avandia, which ruled that it should stay on the market, albeit with dramatic labeling changes.
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