Well, we have what may be considered a major failure of the FDA drug approval process on our hands. The popular blockbuster drug called Avandia has been in the news the past few days for causing more than a 40% increase in the risk for heart attacks and also death in patients.
The independent studies caused enough concern for this to make front page news the past two days, and the FDA is issuing warnings to all Avandia using patients to contact their doctors immediately for a threat assessment in their individual cases.
The diabetes drug was considered a break out diabetes treatment when it came out from maker GlaxoSmithKline PLC, because it was the first drug to help increase insulin tolerance supposedly, and became a hit with doctors prescribing it to some six million diabetes patients.
While experts do say the overall risk of heart attack is relatively small, they do caution Avandia patients to consult their doctors immediately if they are taking the drug, and not to stop the drug themselves before doing so.
The warning on this drug was initiated by research done by two employees of the Cleveland Clinic, close to home for me, but has been questioned by the maker of the drug (of course, to be expected) as inconclusive at best.
The maker of the drug says that in their clinical trials of the drug, there are no such reported effects as are currently being brought to light today, and still back up their product by proclaiming its safety, but are also committed to performing more trials now.