By Umesh Isalkar
Patients suffering from diabetes are in a fix now. The current controversy over Rosiglitazone – the diabetes drug that has been found to increase the risk of heart attacks – has left them in a dilemma. However, experts have clarified that diabetologists are cautious of the risk associated with the drug and are decreasing its usage.
"Diabetologist are aware about the risk associated with Rosiglitazone. However, it is impossible to know how many of them are aware of the recent happening in the USFDA and European Medicine Agency about banning the drug and placing stringent restrictions on its prescription," said senior diabetologist Chittaranjan Yajnik.
The matter has been intensively debated for the last three years. USFDA held two hearings including one in July 2010. It issued a Black Box Warning about Rosiglitazone’s cardiovascular risks, but did not ban it. While European countries have advised discontinuation of the drugs.
"Last week, USFDA issued stringent restrictions on prescribing the drug. The European Medicines Agency last Thursday said it would stop authorising marketing of Avandia (brand name of Rosiglitazone), which will be off the market within the next few months," Yajnik said.
"Despite these developments, there is no definite advice from the Indian authorities to doctors so far. The prescribing doctors and patients receiving this drug should be aware of these international developments and take appropriate action," Yajnik said.
Sharing the view, Sharad Agarkhedkar, president of the city chapter of Indian Medical Association said, "Diabetologists may be aware of the side effects of the Rosiglitazone. But, many patients in our city consult general physicians who may not have updated information about the risks associated with the drug, and the current happenings going on in the US and the European countries over the ban of its sale and restricted prescription."
"Indian policy about the use of drugs is not as strict and stringent as the western countries. Even as several countries start to take action against the drug – Europe and UAE are banning its sale while US has placed stringent restrictions over its sale – India is yet to take a call on whether to take the drug off its shelves," added Agarkhedkar.
An estimated five million diabetics in India are still using the drug, mainly in smaller cities where doctors aren’t aware of the drug’s serious side–effects.
"There are two basic issues in the causative factors of diabetes. One is dysfunction of pancreatic beta cells which leads to insulin deficiency. Second, reduced sensitivity of different tissues to circulating insulin (the so called insulin resistance)," Yajnik said.
Indians are perceived to be more insulin resistant as compared to Europeans and, therefore, drugs which will improve insulin resistance are attractive for the management of diabetes in Indian patients. The commonest drug which reduces insulin resistance is Metformin which predominantly acts on the liver.
The other class of drug molecule which reduces insulin resistance is Glitazones. The first Glitazone to be marketed in the world, including India, was Rosiglitazone in the late 1990’s. This drug has been a focus of controversy since 2007 after publication of a report which stated that it can cause heart attacks.
"A safer Glitazone (pioglitazone) is available in the market and could replace Rosiglitazone. However, this drug also has the side effects of causing weight gain and fluid retention which could be dangerous in patients with heart and kidney problem. These drugs are also known to increase the risk of fractures especially in post–menopausal women," Yajnik said.
A number of drugs to treat diabetes, obesity and related disorders have recently met with a similar fate.
- USFDA had first sounded an alert against Rosiglitazone’s possible side–effects in 2007. A study published in the New England Journal of Medicine had found that Avandia put users at a 60 per cent greater risk of heart failure and a 29 per cent greater risk of death than other medication.
- Professor Steve Nissen, a renowned American cardiologist wrote the report on Rosigluitazone and associated cardiovascular risks in 2007. Nissen had visited Indian to address Cardiology and Diabetes Conference in Mumbai in 2009.
- India’s National Pharmaco Vigilance Advisory Committee had reviewed the scientific data in January 2008 recommended all manufacturers of Rosiglitazone to carry a black box warning on its package, informing consumers and doctors about its possible risks.
- In February 2010, the government had set up a six member committee of experts on the advice of the Drug Technical Advisory Board to decide whether to ban its sale.
- No decision has been taken whether to ban or restrict prescription of Rosilgitazone in India so far.