09 October 2010
By Umesh Isalkar
Union Health Ministry Banned The Drug On Thursday
Doctors in the city have welcomed the Union health ministry’s decision to ban the controversial anti–diabetic drug rosiglitazone (marketed as Avandia) which is linked with cardio–vascular risks. However, they warn that patients who have been taking this pill should stop this medication only after consulting their doctors.
Calling it a welcome move, senior diabetologist Chittaranjan Yajnik said that there was no need to panic as there were many alternative drugs available in the market.
"Rosiglitazone was an effective antidiabetic drug for many patients. Therefore, it will need to be replaced by an appropriate drug. Patients should not worry. Today, many alternative drugs are available," said Yajnik.
The use of rosiglitazone, marketed by drug major GalxoSmithKline as Avandia in many countries, has reported an increasing evidence of heart risk in studies worldwide. While Europe withdrew the highly controversial drug from its shelves last month, US regulators announced tight curbs on its use.
The union health ministry formed a six member committee to take decision on the widely prescribed drug. The committee on Thursday decided to ban the drug with immediate effect all over India. An estimated five million diabetics in India are still using the drug, mainly in smaller cities.
"With this decision, the drug will be pulled out of retail shelves across the country. But, there is no worry as a safer alternative like pioglitazone is available. Though, it is not entirely free from side–effects. These include weight gain, fluid retention and increase risk of fractures. Therefore, it is important that this replacement is done only in consultation with your doctor.
Besides, other classes of antidiabetic drug are also available," said Yajnik. Sharing the view, paediatrician Sharad Agarkhedkar, president of the city chapter of Indian Medical Association (IMA) said, "We use only insulin in children suffering from diabetes. In adults, there is a role of oral hypoglycaemic (sugar lowering) drug. Those who have been taking rosiglitazone can use other drug in glitazone family with due consultation with diabetologists."
"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 1990s. This drug has been a focus of controversy since 2007 after publication of a report which stated that it can cause heart attacks, said Yajnik.
"The decision is welcome. There are still many medicine and drug molecules which are banned in most countries, but still in use in India. The ministry should take proactive steps towards banning them. Besides, many irrational drug combinations are available over the counter (OTC) in India. A few of them are really harmful," said Avinash Bhondwe, former president of IMA, Pune branch.
- USFDA had first sounded an alert against rosiglitazone’s possible sideeffects 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 rosiglitazone and associated cardiovascular risks in 2007. Nissen had visited India 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 recommending 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.
- A union health ministry’s committee decided to ban rosiglitazone with immediate effect all over India on October 7.