In the month after the health risks of Avandia were exposed in the New England Journal of Medicine, the reports of side effects being made to federal regulators tripled.
Avandia, also sold under the name Avandamet, was found to increase the risk of heart attacks by 43 percent. It’s used to control blood sugar and is prescribed to more than 6 million people worldwide who suffer from Type 2 diabetes.
Since diabetics are already in the elevated risk category for heart attacks, the idea of a diabetes medication increasing that risk to such an extent is disturbing news.
In the 35 days prior to the release of the study, five heart attacks had been reported, compared with 90 cases in the same period afterward. Heart related hospitalizations went from 11 to 126, and deaths attributed to the medication rose from 11 to 38.
It is believed that the spike in post-market side effect reports was due to a lack of knowledge about the potential side effects by doctors. They simply did not correlate their patients’ heart problems with the medication.
It also highlights the ineffectiveness and inadequacy of the current reporting system, which is the only thing the FDA relies on to measure a drug’s safety once it’s on the market. Reporting suspected side effects of a drug is voluntary and completely un-enforced, which leads to a rather haphazard, incomplete and incorrect evaluation of the real damage being inflicted.
—-Yahoo News, July 13, 2007
Editor’s Comment: This is not an insignificant problem, as one in three Americans has either pre-diabetes or diabetes.
Avandia has been on the market for eight years, even though GlaxoSmithKline’s own analysis indicated heightened cardiac risks at least a year before the New England Journal study was published.
All the way back in 2000 there were also published reports about Avandia’s role in causing liver failure. Yet, the FDA stood idly by, allowing an untold number of individuals to put their lives at risk. No doubt thousands have already lost their lives unnecessarily.
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