FDA advisers voted 14-2 that the FDA should require drug makers to show that experimental diabetes drugs don't increase cardiovascular risks. Many diabetes drugs lower blood sugar but they still pose risks for the heart.
The panel recommended the FDA instruct drug manufacturers to conduct long-term studies in order to rule out cardiovascular risks in the diabetes drugs. Most panel members also suggested that companies start the studies before the drug is approved and complete them after approval.
The move comes after an analysis suggested that Avandia, a drug for type 2 diabetes, can raise heart attack risks by as much as 40 percent. Despite warnings from the FDA, the company says the drug is safe, and it remains on the market.
If the FDA takes the panel's advice, the new recommendations could prove costly for pharmaceutical companies as it takes a longer time and more resources to prove the drugs don't pose any cardiovascular threat. The FDA is not required to follow the panel's advice, though it often does.
The only drug that fulfils the criteria of being safe for diabetes patients is Merck's Januvia. Trials have shown that the drug does not pose any risk to heart patients.
As many as 24 million Americans suffer from type 2 diabetes; it's a leading cause of death and disability.
