FDA slaps Glaxo
In April the Food and Administration (FDA) reprimanded GlaxoSmithKline (GSK) for failing to report all of its post approval data on rosiglitazone (Avandia) which is the company's diabetes drug.
Avandia has received much publicity since May 2007 when a meta-analysis showed a significant increase in the risk of heart attacks and in increase in cardiovascular death.
The FDA sent a letter to the chief executive officer of GSK stating an inspection in late 2007 focusing on compliance with post marketing adverse drug experience reporting requirements failed to report data relating to clinical experience, along with other data and information.
The inspection revealed that the company failed to report multiple post marketing studies involving Avandia.
The FDA stated that nine studies were not disclosed until September 2007 and another 11 studies were not included in required annual reports, although some data were submitted to the agency in other reports or communications.
GSK acknowledged the FDA letter and stated that corrective steps are being taken to "make sure we file periodic reports completely and promptly.
Once again, the information physicians receive from the companies is lacking emphasizing the ongoing need to utilize our own discernment, judgment and experience when treating patients.
As my motto goes; “Never be the first on a drug, or never be the last on a drug”
Avandia has received much publicity since May 2007 when a meta-analysis showed a significant increase in the risk of heart attacks and in increase in cardiovascular death.
The FDA sent a letter to the chief executive officer of GSK stating an inspection in late 2007 focusing on compliance with post marketing adverse drug experience reporting requirements failed to report data relating to clinical experience, along with other data and information.
The inspection revealed that the company failed to report multiple post marketing studies involving Avandia.
The FDA stated that nine studies were not disclosed until September 2007 and another 11 studies were not included in required annual reports, although some data were submitted to the agency in other reports or communications.
GSK acknowledged the FDA letter and stated that corrective steps are being taken to "make sure we file periodic reports completely and promptly.
Once again, the information physicians receive from the companies is lacking emphasizing the ongoing need to utilize our own discernment, judgment and experience when treating patients.
As my motto goes; “Never be the first on a drug, or never be the last on a drug”
Labels: drugs, FDA, healthcare
posted by Anonymous at 6:00 AM
1 Comments:
Unfortunately physicians are not always allowed to make those decisions. Many insurance companies still will not approve newer drugs (such as Januvia) unless patients have tried and failed on drugs like Avandia, even if they have numerous risk factors for cardiac disease and have had unsatisfactory results from sulfonylureas. Your mantra no longer matters. You no longer can practice medicine in a fashion that you believe is best for your patient. Insurance companies rule.
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