The Union government's decision to revoke the ban on Pioglitazone, the anti-diabetes drug, evoked mixed responses from doctors in the city, with opinions divided across the medical community.
An estimated 30 lakh diabetics used Pioglitazone combinations in India before it was banned. With furore over research reports linking the drug tobladder cancer in eight patients with type 2 diabetes, the Union government banned the drug in early July. The ban was revoked hastily, in the week of July 12, 2013.
"Pioglitazone is good anti-diabetic drug, especially for our country, where insulin resistance is common. But heavy doses of the drug should be avoided," said Mangala Borkar, head of the medicine department, Government Medical College and Hospital, Aurangabad, "It is not supplied to government hospitals, but it has been largely used in private hospitals, especially because it was affordable." Borkar emphasised that Pioglitazone should only be "a third or fourth option" and should be used "only if necessary and in small doses".
"The drug should be used judiciously. The benefits of this 'insulin sensitiser' outweighs the risks. Pioglitazone is probably the most potent and effective oral drug option among the five available groups, the sixth being insulin," said endocronologist Hemant Phale.
Criticising the government's decision to revoke the ban, diabetologist Archana Sarda pointed out its "significant side-effects". "A thorough research should be conducted in India. The ultimate bottomline should be the safety of patients," said Sarda.
"As per the research reports from various diabetes research centres in India, eight cases of bladder cancer in patients with type 2 diabetes on Pioglitazone have been reported. Three of the patients were from Chennai, two from Salem and one each from Belgaum, Hyderabad and Mumbai. Seven of the eight patients were males. The patients ranged in age from 43 years to 76 years. They all had type 2 diabetes and were on Pioglitazone for periods ranging from two to nine years," explained physician Aniket Inamdar.
"The mean dose of Pioglitazone ranged from 15 mg to 30 mg per day. While seven patients had transitional cell (urothelial) carcinoma on biopsy, the nature of malignancy was not clear in the eighth patient. Seven patients are presently on follow-up with urologists and oncologists, whereas the eighth patient developed metastases to the liver and lungs and died in November 2011 after several cycles of chemotherapy and two surgeries. The single female patient developed bladder cancer seven years ago while on 30 mg of Pioglitazone."
"She underwent surgery for the same in the US and was declared free of malignancy. Since the link of Pioglitazone with bladder cancer was not known at that time, she was continued on Pioglitazone even after the surgery. She developed recurrence of haematuria and pain four months later and had to undergo repeat surgery and chemotherapy."
"This is, to the best of our knowledge, the first report on bladder cancer among Pioglitazone users in India and one of the first in a female patient. Although one cannot draw any conclusions of causality from these eight cases, the development of this relatively uncommon malignancy in eight patients who were on this particular drug does raise concern about the long-term safety of Pioglitazone. Clinicians should therefore exercise extreme caution in the use of this drug. Patients should be made aware of this potential side-effect of pioglitazone and should be allowed to make informed choices regarding its use," said Inamdar.
(Source: times of India)
An estimated 30 lakh diabetics used Pioglitazone combinations in India before it was banned. With furore over research reports linking the drug tobladder cancer in eight patients with type 2 diabetes, the Union government banned the drug in early July. The ban was revoked hastily, in the week of July 12, 2013.
"Pioglitazone is good anti-diabetic drug, especially for our country, where insulin resistance is common. But heavy doses of the drug should be avoided," said Mangala Borkar, head of the medicine department, Government Medical College and Hospital, Aurangabad, "It is not supplied to government hospitals, but it has been largely used in private hospitals, especially because it was affordable." Borkar emphasised that Pioglitazone should only be "a third or fourth option" and should be used "only if necessary and in small doses".
"The drug should be used judiciously. The benefits of this 'insulin sensitiser' outweighs the risks. Pioglitazone is probably the most potent and effective oral drug option among the five available groups, the sixth being insulin," said endocronologist Hemant Phale.
Criticising the government's decision to revoke the ban, diabetologist Archana Sarda pointed out its "significant side-effects". "A thorough research should be conducted in India. The ultimate bottomline should be the safety of patients," said Sarda.
"As per the research reports from various diabetes research centres in India, eight cases of bladder cancer in patients with type 2 diabetes on Pioglitazone have been reported. Three of the patients were from Chennai, two from Salem and one each from Belgaum, Hyderabad and Mumbai. Seven of the eight patients were males. The patients ranged in age from 43 years to 76 years. They all had type 2 diabetes and were on Pioglitazone for periods ranging from two to nine years," explained physician Aniket Inamdar.
"The mean dose of Pioglitazone ranged from 15 mg to 30 mg per day. While seven patients had transitional cell (urothelial) carcinoma on biopsy, the nature of malignancy was not clear in the eighth patient. Seven patients are presently on follow-up with urologists and oncologists, whereas the eighth patient developed metastases to the liver and lungs and died in November 2011 after several cycles of chemotherapy and two surgeries. The single female patient developed bladder cancer seven years ago while on 30 mg of Pioglitazone."
"She underwent surgery for the same in the US and was declared free of malignancy. Since the link of Pioglitazone with bladder cancer was not known at that time, she was continued on Pioglitazone even after the surgery. She developed recurrence of haematuria and pain four months later and had to undergo repeat surgery and chemotherapy."
"This is, to the best of our knowledge, the first report on bladder cancer among Pioglitazone users in India and one of the first in a female patient. Although one cannot draw any conclusions of causality from these eight cases, the development of this relatively uncommon malignancy in eight patients who were on this particular drug does raise concern about the long-term safety of Pioglitazone. Clinicians should therefore exercise extreme caution in the use of this drug. Patients should be made aware of this potential side-effect of pioglitazone and should be allowed to make informed choices regarding its use," said Inamdar.
(Source: times of India)
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