Doctors Concerned as India Suspends Diabetes Drug Pioglitazone
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Diabetologists in India are up in arms following
an unexpected decision by the government there to suspend sales of the
diabetes drug pioglitazone. The ruling came seemingly out of the
blue, and there is much concern among doctors about their patients with
type 2 diabetes who are currently taking this medication.
The government suspended the manufacture, sale, and distribution of pioglitazone at the end of June, citing concerns over adverse effects, particularly bladder cancer, according to a report in BMJ and a number of Indian media outlets.
Vijay Panikar, MD, an endocrinologist from Lilavati Hospital, Bandra, Mumbai, who is also the secretary of the Association for Diabetes Care and Prevention, told Medscape Medical News: "I think it's unfortunate. Pioglitazone should not have been banned. The government could have put some restrictions [on it] but still allowed marketing of the drug because there is no clear-cut indication that it does cause bladder cancer." In fact, he said, "there are new data coming, which are probably in favor of pioglitazone, expected in 2014."
And the secretary general of the Indian Pharmaceutical Alliance, which represents 19 research-based national pharmaceutical companies, Beilib D.G. Shah, said his members are also infuriated by this decision, which he says is wrong on a number of levels.
"First, the due process of law for suspensions was not followed," Shah told Medscape Medical News, adding that normally there is a procedure for this type of legislation, with logical steps, none of which were followed in this case. Second, "the government cites the fact that pioglitazone is banned in France and Germany," but the French ban "was 3 years ago," Shah noted, and in Germany "they have suspended sales to new patients" only, he said.
"This drug has been on the Indian market for 12 years, and there has been no suggestion of a link with bladder cancer. This decision has put 3 million patients on pioglitazone at risk and has come so suddenly. Now they will have to go to their diabetologist or doctor and discuss what therapy to change to. One of their choices now is to move to a new therapy, at 10 times the cost. There is a suspicion that some foreign companies [have pressured for this] to switch patients from safe low-cost treatments to newer therapies such as gliptins," he asserted.
Medscape Medical News tried to speak with a representative of the Indian government. But G.N. Singh, PhD, the drugs controller general of India, was overseas and could not be contacted, and Dr. Arun Panda, of the Ministry of Health and Welfare, could not be reached for comment.
Pioglitazone "Cornerstone of Therapy" in India
The thiazolidinedione drug class, which includes rosiglitazone (Avandia, GlaxoSmithKline) as well as pioglitazone, has never been far from controversy. Rosiglitazone was suspended by the European Union in 2010 and its use severely restricted in the United States because of concerns about a possible increased risk of cardiovascular adverse effects, although this assertion has recently been challenged in the second in a high-profile Food and Drug Administration advisory committee meeting.
Shah told Medscape Medical News that rosiglitazone was removed from the Indian market around the same time as it was suspended in Europe, leaving pioglitazone — originally developed by Takeda Pharmaceuticals and marketed as Actos but now widely available as a generic medication — as the remaining thiazolidinedione. It, too, has been associated with adverse effects, including fractures and fluid retention, but bladder cancer is probably the greatest concern. Although pioglitazone has remained on the market in many countries, some — including France and Germany — have banned it or severely restricted its use.
Indian patients are particularly well suited to pioglitazone, Dr. Panikar told Medscape Medical News, "because they have a lot of insulin resistance, so this drug is ideal for that." In fact, pioglitazone "is the cornerstone of treatment in most patients" in India, he stated.
Most in India are taking pioglitazone in combination with either metformin or a sulfonylurea, with many using fixed-dose combination products. Now that pioglitazone is suddenly unavailable, "the next step is to give gliptins or insulin," he explained. However, gliptins "are probably 10 times the price" of pioglitazone, so "a large number of patients…cannot afford this at all," and they also say, "Why should we take insulin…when all this time we were controlled without insulin?" he observed.
He noted that pioglitazone is used in very low doses in India, 7.5 to 15 mg daily. "If you don't have a contraindication for the use of pioglitazone, it should be used in a low dose," he asserted.
Dr. Panikar and others also stress that pioglitazone remains on the market in the United States, the United Kingdom, and in many other Western nations and that it is endorsed and recommended for diabetes management by many respected organizations, including the American Diabetes Association (ADA), the European Association for the Study of Diabetes (EASD), and the International Diabetes Federation (IDF).
"We are worried, rather than being angry. We are concerned about our patients. We are making appeals to the government to reconsider the decision. Associations are in the process of putting together appeals, which will be presented, and we are hopeful they will reverse this decision," Dr. Panikar said.
Most Indians Cannot Afford Newer Medications
Pioglitazone has been available generically in India for some time, but newer oral type 2 diabetes medications, such as the gliptins (dipeptidyl peptidase-4 [DPP-4] inhibitors), are available only as branded products from Western companies, said Shah, whose organization represents domestic firms, such as Dr. Reddy's Laboratories and Ranbaxy Laboratories. There is 1 exception to this, with the Indian company Glenmark Pharmaceuticals, selling a cheaper version of one of the gliptins, but this is being legally challenged, he noted.
He said that the Indian government ruling on pioglitazone specifically cites that all "drug formulations containing pioglitazone are likely to involve risk to human beings" and states that "safer alternatives to the said drug are available."
While it is true that alternatives are available, many people simply cannot afford them, he maintained. "Around a third" of existing patients could probably afford to switch to newer diabetes medications, but the remainder cannot, he explained.
The market for pioglitazone in India is estimated to be worth about Rs7 billion ($120 million) a year, but the medication is cheap for individual patients, priced as low as Re1 to Rs4 per tablet, according to Indian reports.
But, "We haven't heard the last word yet," Shah asserted. Following "strong protestations" from a number of quarters, the government has now backtracked a little and agreed to a meeting of "technical experts" to discuss the situation, possibly as early as next week, he told Medscape Medical News.
The government suspended the manufacture, sale, and distribution of pioglitazone at the end of June, citing concerns over adverse effects, particularly bladder cancer, according to a report in BMJ and a number of Indian media outlets.
Vijay Panikar, MD, an endocrinologist from Lilavati Hospital, Bandra, Mumbai, who is also the secretary of the Association for Diabetes Care and Prevention, told Medscape Medical News: "I think it's unfortunate. Pioglitazone should not have been banned. The government could have put some restrictions [on it] but still allowed marketing of the drug because there is no clear-cut indication that it does cause bladder cancer." In fact, he said, "there are new data coming, which are probably in favor of pioglitazone, expected in 2014."
And the secretary general of the Indian Pharmaceutical Alliance, which represents 19 research-based national pharmaceutical companies, Beilib D.G. Shah, said his members are also infuriated by this decision, which he says is wrong on a number of levels.
"First, the due process of law for suspensions was not followed," Shah told Medscape Medical News, adding that normally there is a procedure for this type of legislation, with logical steps, none of which were followed in this case. Second, "the government cites the fact that pioglitazone is banned in France and Germany," but the French ban "was 3 years ago," Shah noted, and in Germany "they have suspended sales to new patients" only, he said.
"This drug has been on the Indian market for 12 years, and there has been no suggestion of a link with bladder cancer. This decision has put 3 million patients on pioglitazone at risk and has come so suddenly. Now they will have to go to their diabetologist or doctor and discuss what therapy to change to. One of their choices now is to move to a new therapy, at 10 times the cost. There is a suspicion that some foreign companies [have pressured for this] to switch patients from safe low-cost treatments to newer therapies such as gliptins," he asserted.
Medscape Medical News tried to speak with a representative of the Indian government. But G.N. Singh, PhD, the drugs controller general of India, was overseas and could not be contacted, and Dr. Arun Panda, of the Ministry of Health and Welfare, could not be reached for comment.
Pioglitazone "Cornerstone of Therapy" in India
The thiazolidinedione drug class, which includes rosiglitazone (Avandia, GlaxoSmithKline) as well as pioglitazone, has never been far from controversy. Rosiglitazone was suspended by the European Union in 2010 and its use severely restricted in the United States because of concerns about a possible increased risk of cardiovascular adverse effects, although this assertion has recently been challenged in the second in a high-profile Food and Drug Administration advisory committee meeting.
Shah told Medscape Medical News that rosiglitazone was removed from the Indian market around the same time as it was suspended in Europe, leaving pioglitazone — originally developed by Takeda Pharmaceuticals and marketed as Actos but now widely available as a generic medication — as the remaining thiazolidinedione. It, too, has been associated with adverse effects, including fractures and fluid retention, but bladder cancer is probably the greatest concern. Although pioglitazone has remained on the market in many countries, some — including France and Germany — have banned it or severely restricted its use.
Indian patients are particularly well suited to pioglitazone, Dr. Panikar told Medscape Medical News, "because they have a lot of insulin resistance, so this drug is ideal for that." In fact, pioglitazone "is the cornerstone of treatment in most patients" in India, he stated.
Most in India are taking pioglitazone in combination with either metformin or a sulfonylurea, with many using fixed-dose combination products. Now that pioglitazone is suddenly unavailable, "the next step is to give gliptins or insulin," he explained. However, gliptins "are probably 10 times the price" of pioglitazone, so "a large number of patients…cannot afford this at all," and they also say, "Why should we take insulin…when all this time we were controlled without insulin?" he observed.
He noted that pioglitazone is used in very low doses in India, 7.5 to 15 mg daily. "If you don't have a contraindication for the use of pioglitazone, it should be used in a low dose," he asserted.
Dr. Panikar and others also stress that pioglitazone remains on the market in the United States, the United Kingdom, and in many other Western nations and that it is endorsed and recommended for diabetes management by many respected organizations, including the American Diabetes Association (ADA), the European Association for the Study of Diabetes (EASD), and the International Diabetes Federation (IDF).
"We are worried, rather than being angry. We are concerned about our patients. We are making appeals to the government to reconsider the decision. Associations are in the process of putting together appeals, which will be presented, and we are hopeful they will reverse this decision," Dr. Panikar said.
Most Indians Cannot Afford Newer Medications
Pioglitazone has been available generically in India for some time, but newer oral type 2 diabetes medications, such as the gliptins (dipeptidyl peptidase-4 [DPP-4] inhibitors), are available only as branded products from Western companies, said Shah, whose organization represents domestic firms, such as Dr. Reddy's Laboratories and Ranbaxy Laboratories. There is 1 exception to this, with the Indian company Glenmark Pharmaceuticals, selling a cheaper version of one of the gliptins, but this is being legally challenged, he noted.
He said that the Indian government ruling on pioglitazone specifically cites that all "drug formulations containing pioglitazone are likely to involve risk to human beings" and states that "safer alternatives to the said drug are available."
While it is true that alternatives are available, many people simply cannot afford them, he maintained. "Around a third" of existing patients could probably afford to switch to newer diabetes medications, but the remainder cannot, he explained.
The market for pioglitazone in India is estimated to be worth about Rs7 billion ($120 million) a year, but the medication is cheap for individual patients, priced as low as Re1 to Rs4 per tablet, according to Indian reports.
But, "We haven't heard the last word yet," Shah asserted. Following "strong protestations" from a number of quarters, the government has now backtracked a little and agreed to a meeting of "technical experts" to discuss the situation, possibly as early as next week, he told Medscape Medical News.
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