The recent serious FDA warnings on possible serious heart risks for the diabetes drug Avandia, a widely prescribed drug that generated billions in revenue yearly, are only the latest in a serious of warnings about the dangers of the drug that raise more questions about the ability and quality of FDA safety monitoring. The question is why did it take so long?

While one problem is that serious risk warnings surfaced many years ago, another is that the drug manufacturer was strongly admonished on several occasions by the FDA for minimizing the risks of the drug.

Yet, until now, little action has been taken to protect the safety of consumers

Clear Warnings
In February of 2001 the FDA required new label warnings for the drug after studies suggested a link between Avandia and heart failure in certain situations.

Under the new labeling read in part, “Cardiac Failure and Other Cardiac Effects: Avandia, like other thiazolidinediones, alone or in combination with other antidiabetic agents, can cause fluid retention, which may exacerbate or lead to heart failure. Patients should be observed for signs and symptoms of heart failure. Avandia should be discontinued if any deterioration in cardiac status occurs.”

According to the New York Times, even prior to this well known Diabetes specialist sent a letter to the FDA warnings of “a worrisome trend in cardiovascular deaths and severe adverse events” in patients using the drug. The letter was written by Dr John Buse, president-elect of the American Diabetes Association and faculty member at the University of North Carolina in Chapel Hill

A personal report, and impact, of Avandia risks was presented to the FDA in 2000 in a letter by Robert A. Bowen a diabetes patient whose doctor switched him to Avandia. “On Dec. 19, 1999, my doctor switched me to Avandia 8mg per day. On January 17, 2000, my feet, legs and thighs swelled to twice there size with no warning whatsoever.” Mr. Bowen continues, “I was diagnosed with congestive heart failure. (I have never been advised of any previous heart problems in my entire life.) …My doctor told me that he is quite certain that all this was triggered by taking Avandia for over 3 months and I must agree. Neither the doctor nor I were warned regarding these serious side effects of Avandia!”

GLAXO Minimizes Risks
Another problem has been how GSK played down risks when marketing Avandia. In July of 2001, the FDA issued a warning letter to GSK regarding the company was ignoring risks.

In that letter the FDA harshly admonished GSK concluding, ”that GSK ha promoted Avandia in violation of the Federal Food, Drug, and Cosmetic Act.”

The letter goes on to say, “Your promotional activities that minimize serious new risks are particularly troublesome because we have previously objected, in two untitled letters, to your dissemination of promotional materials for Avandia that failed to present any risk information about Avandia..”

Another important point in the recent studies highlighting of the risks of Avandia is that the information to conduct those studies is available only because GSK was forced in the settlement of a lawsuit to make all the study available for Avandia public. Since drug makers are not now required to make all studies publicly available, the issue would have remained buried.

It all begs the question of how many other Avandia situations are out there.

Source
FDA Avandia Labeling
Letter by Mr. Robert Bowen
FDA Warning Letter to Glaxo-SmithKlien