The latest Union government gazette notice issued on July 31 lifted the ban on the manufacturing and sales of the drug, Pioglitazone, whilst stating that the drug won’t be used as a first line of therapy for diabetes.
The notice laid down some guidelines for using the drug that is widely recommended for treating diabetes. For instance; prescribing lowest possible doses to elderly patients and gauging the risk for developing bladder cancer, knowing the smoking habits of the patient, and his exposure to chemotherapy agents before using the drug, if there is.
Also known as insulin sensitizer, Pioglitazone is an oral drug that reduces the amount of glucose in the blood, thus making the body more responsive to insulin. Since type 2 diabetes patients can’t make enough insulin and the cells of their body respond less to the insulin that is produced, the reduced amount of insulin cause cells to take up less glucose from the blood. This increases the level of glucose to rise in the blood.
A G Unnikrishnan, a city-based endocrinologist said, “We must continue to recognise the benefits of pioglitazone and use it judiciously. It is important to weigh the risks and benefits of therapy, discuss the findings with patients and make the right decision”. He also emphasised that the first line of treatment for type 2 diabetes is diet and exercise followed by a medication called metformin.
While elaborating on the guidelines, Unnikrishnan said, “Studies have shown that the risk of bladder cancer was higher with use of high doses for more than two years. Hence, the government notification states that the lowest possible doses should be prescribed to the elderly, who may be more susceptible to bladder cancer as well as increased fracture risk”.
Abhay Mutha, founder-president of the Diabetes Care and Research Foundation, also said that despite putting more than 2,000 patients on the drug, he hardly dealt with any problem. “Use of pioglitazone should ideally be stopped if a patient gains 4 kg or more in three months and sees no clinical benefit from the drug. If this drug is used without any monitoring, patients will definitely have small complications,” he added.
The drug first came under the scanner when the health ministry received objectionable letters from doctors. One of them was Chennai-based diabetologist Dr V Mohan who in his January 2013 letter to the PM and health minister mentioned that he had found eight cases of bladder cancer in relation with pioglitazone use.
“You will agree that as far as human lives are concerned, it does not matter even if only a few people develop bladder cancer and die. No drug which produces cancer should be allowed to be used in human beings. I, therefore, request you to take steps to ban pioglitazone use in the Indian market,” he said.
Finally, Pioglitazone was banned the Union Health Ministry on July 18. However, the ban was revoked within two weeks owing to protests by doctors and patients who said the ministry’s decision had been hasty. The drug will now be available in markets in a new box with a “warning” about its side effects in two weeks to a month’s time.
Source: TOI, Indian Express, Medicinenet.com, HT