From the NEJM.
"Unless new data provide a different picture of the risk–benefit profile, regulatory action by the Food and Drug Administration (FDA) is now warranted. If patients using rosiglitazone are concerned about the findings of this meta-analysis, they should discuss them with their physicians and not unilaterally stop taking the medication. Ongoing trials using rosiglitazone may provide important new data, but for a drug approved in 1999, the delay in obtaining information about health outcomes has already been considerable.
During the market life of rosiglitazone, tens of millions of prescriptions for the drug have been written for patients with type 2 diabetes. Insofar as the findings of Nissen and Wolski represent a valid estimate of the risk of cardiovascular events, rosiglitazone represents a major failure of the drug-use and drug-approval processes in the United States."
So, will Avandia bite the dust too and go the same way as Manoplax, Prepulsid, Melleril, Vioxx, etc. Or, will we have the reps around again telling us that the meta-analysis isn't valid, the study is poor and Avandia (and presumably Avandamet too) will make our diabetic patients life forever? Okay, I'm paraphrasing what the rep said, but it isn't far off.
"Unless new data provide a different picture of the risk–benefit profile, regulatory action by the Food and Drug Administration (FDA) is now warranted. If patients using rosiglitazone are concerned about the findings of this meta-analysis, they should discuss them with their physicians and not unilaterally stop taking the medication. Ongoing trials using rosiglitazone may provide important new data, but for a drug approved in 1999, the delay in obtaining information about health outcomes has already been considerable.
During the market life of rosiglitazone, tens of millions of prescriptions for the drug have been written for patients with type 2 diabetes. Insofar as the findings of Nissen and Wolski represent a valid estimate of the risk of cardiovascular events, rosiglitazone represents a major failure of the drug-use and drug-approval processes in the United States."
So, will Avandia bite the dust too and go the same way as Manoplax, Prepulsid, Melleril, Vioxx, etc. Or, will we have the reps around again telling us that the meta-analysis isn't valid, the study is poor and Avandia (and presumably Avandamet too) will make our diabetic patients life forever? Okay, I'm paraphrasing what the rep said, but it isn't far off.
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