Diabetes Drugs Must Face Tougher Safety Standards, says FDA Panel

The U.S. Food and Drug Administration (FDA) advisers on Wednesday said that the new diabetes drugs aimed to control type 2 diabetesdefine should undergo longer studies to assess long term heart risks before making them available in the market.

The FDA advisors voted 14-2 at the end of the two-day meeting and recommended that the FDA should add long term cardiovascular safety trials, even if the drugs don’t show any negative effect on the heart in the starting trials. There are several diabetes drugs which lower the blood sugar but they still pose risks for the heart.

Robert Temple, director of the FDA's office of medical policy said, "The most important thing they were saying is, 'Yeah, you need cardiovascular outcome data."'

But one panelist had his own doubt about the recommendation of long research on heart attack risks. Dr. Eric Felner from Emory University School of Medicine said, "If you wait this amount of time for testing you're going to be preventing certain drugs from getting out there that may be better than what we already have."

Generally FDA doesn’t need to follow the recommendations of its advisory panels’ but most of the time it does and if it does than it will prove costly for drug manufactures as it takes a bigger, longer trial to prove heart safety than to prove blood-sugar control.

The move came after when last year in May, a study conducted by Nissen and colleague Kathy Wolski found that patients taking GlaxoSmithKline’s Avandia, a drug used for treating type 2 diabetesdefine has an increased heart attack risks by as much as 40%. Even after getting warnings from the FDA, the company says the drug is safe, and it remains on the market.

The leading pharmaceutical companies dominating the US market are GlaxoSmithKline's Avandia, Takeda Pharmaceuticals' Actos, Eli Lilly and Amylin Pharmaceutical's Byetta. According to healthcare information company IMS Health, the U.S. market for the top selling diabetes medicines now grew to more than $6 billion from past year.

Merck & Co’s Januvia is already approved by FDA as safe drug for diabetes patients. The research showed that the drug does not pose any risk to heart patients.

Approximately 24 million people in US alone suffer from type 2 diabetes also known as lifestyle diabetes, linked with obesity, poor diet and sedentary lifestyle. It affects nearly 85 to 90% of all people with diabetes.

Diabetes is the seventh leading causes of death and disability in the United States, sixth leading cause of death in Australia, which has become a nation of fatties. The disease can cause serious health complications including cardiovascular disease, kidney failure, eye damage, impotence, neuropathy and feet problems.

Nearly 75% of the diabetic patients die of heart disease. The causes of type 2 diabetes are known and in some cases it can be prevented; however there is no cure for type 2 diabetes.

Bristol-Myers Squibb Co. and AstraZeneca Plc are planning to submit a new class of diabetes treatments for FDA approval later this year.