Interviewu with expert Dr Rajiv Kovil, renowned diabetologist from India
Could you tell us why pioglitazone has been banned from several markets worldwide?
Dr Kovil: It doesn’t make any sense at all, because neither did the USFDA find any evidence to ban pioglitazone , nor did the EMEA (European Medicines Agency). I for one do not understand where the health authorities in India found enough evidence to ban the drug and its combinations. There is no evidence across the globe sufficient enough to ban it.
The newspapers have reported that the drug is banned in the US, UK and Australia. Is that true?
Dr Kovil: That is not true. It has been banned only in France and certain parts of Europe. It was banned when the controversy about bladder cancer came up. It has been two years since then, and there has been a lot of clarity following those findings. Another factor that comes to mind are the findings about heart failure and pioglitazone. It has been almost six to seven years since then and there have been subsequent trials showing that there is no increase in the risk of heart failure, it is just that doctors should use the drug with caution in people who are at a higher risk of developing heart disease.
How is banning the drug now, justified?
Dr Kovil: Banning pioglitazone in 2013 is wrong timing because there is no new evidence to show its ill effects. On the contrary the USFDA had called back an earlier drug – doziglitazone last month and it will be commercially available in India in a few months. As for pioglitazone, the USFDA has just allowed the prescription of pioglitazone with a DPP4 drug called alogliptin. I was recently at a meeting where they presented fantastic evidence of the efficacy of pioglitazone in newly diagnosed diabetics. So I don’t see the scientific evidence to ban the product. At least what they could have done before banning the product is to give a warning.
For a drug of this class, the warning is printed on a black background to indicate its importance. With no real evidence supporting its ill effects, the administration can’t just ban a product.
My question is why today? If they had banned it two years back when France and two other European nations had, it would have made sense, but today, there is no evidence to do so. On the contrary those countries that had banned it earlier are reviewing the data to see if they should lift the ban. In India most clinicians have brought down the use of pioglitazone to a level of 7.5mg, whereas the approved dosage is 15mg. We have found, that clinically the amount of complications, the fluid retention is almost negligible.
The study on bladder cancer was related to higher dosages of pioglitazone. and since we are using much lower doses, there is no evidence that banning it in India is the right thing to do. How will this ban affect people suffering from diabetes?
Dr Kovil: Pioglitazone is a good nuclear level drug and not to mention much cheaper than other alternatives. When you don’t use pioglitazone the use of insulin and other more expensive drugs goes up. So finally, the patient will have to bear the brunt of this ban. As doctors we will be forced to use more potent drugs coupled with higher doses of insulin.
See video below with Dr. Kovil.
The latest news
The Indian government’s suspension of the diabetes drug pioglitazone may soon be revoked if the government follows the advice of the Drug Technical Advisory Board (DTAB) there. The DTAB met July 19 2013 and recommended that pioglitazone be put back on the market in India, albeit with a boxed warning about bladder cancer.
The decision by the Indian government to suspend the manufacture, sale, and distribution of pioglitazone, citing concerns over adverse effects, particularly bladder cancer, came out of the blue last month, and was widely criticized by doctors and others there, as reported by Medscape Medical News
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