You would expect that when a pharmaceutical company conducts a study to assess the safety of a medication that the results would be taken seriously and properly evaluated. Well, that’s what would happen in a perfect world. But, as I am sure many of you reading this already know, that does not always happen. The manufacturer of Actos (pioglitazone), Takeda, undertook a two year carcinogenicity study in male and female rats. The study did not show drug-induced tumors in any organ EXCEPT for the bladder.
However, it was determined by Takeda that this evidence did not point to a risk in humans. Not only did Takeda know of the results of this study but so did regulatory agencies such as the European Medicines Agency (EMA). Takeda’s solution to this problem was to minimize the results but agree to undertake a long-term study to assess the safety of Actos.
The problem with a long-term study is just that: they are long. We are now in 2011 and the FDA only recently evaluated the half-way mark of a ten year epidemiological study occurring at Kaiser Permanente. The five-year results showed that an “increased risk of bladder cancer was noted among patients with the longest exposure to pioglitazone, and in those exposed to the highest cumulative dose of pioglitazone.”
Didn’t we know that in 2000? And yet, Actos has now been on the market an additional eleven years. Since Actos is one of the top selling drugs in the United States, it can only be assumed that in those eleven years an astonishing amount of prescriptions have been written to diabetic patients. In fact, according to the FDA, approximately 2.3 million prescriptions for Actos, or a medication containing the same active ingredient, were filled from January 2010 through October 2010.
With mounting evidence that Actos can increase the risk of bladder cancer, the FDA will take it off the market, right? Wrong.
The FDA’s solution, as of now, is to require an updated label. On August 4, 2011, the FDA approved an update to the Actos label which recommends that healthcare professionals should not use pioglitazone in patients with active bladder cancer and to use caution in using it in patients with a prior history of bladder cancer.
How long will it now take for the FDA to follow suit with France and Germany who have banned Actos? The length of time that it takes to have a dangerous product removed from the market can be astonishing and frustrating. It is hard to believe that this drug showed bladder tumors in rats in 2000. Here we are in 2011 with an updated label and increasing evidence that Actos has the same effect on humans.
It’s time for you to take matters into your own hands. If you are currently on Actos, please see your doctor if you have any concerns or if you demonstrate any symptoms. It is important to have this discussion with your doctor in order to determine if there may be a safer alternative but never stop taking a medication with first consulting a doctor.