Diabetes Drug Heart Side Effects Must Be Weighed Before FDA Approval

Under a new FDA policy announced Wednesday, manufacturers of new diabetes drugs will have to closely examine potential heart risks, to provide evidence that the drugs will not increase the risk of cardiovascular events, like heart attacks. However, it is unclear how this will be applied to drugs already approved, such as Avandia, which has been linked to an increased risk of congestive heart failure, heart attacks and death.

Diabetics have an increased risk of heart disease and heart attacks are already the leading cause of death. Drugs which are prescribed to treat diabetes by lowering blood sugars could do more harm than good if side effects increase the risk of heart problems.

Concerns about potential heart side effects of diabetes drugs have garnered a lot of attention in recent years, after a report published by the New England Journal of Medicine in May 2007 indicated that the popular diabetes drug Avandia increases the risk of heart attacks by 43% and the risk of cardiovascular death by as much as 64% when compared to those taking another diabetes drug or a placebo.

There are over 23 million people in the United States with type 2 diabetes, and drugs prescribed to treat the condition are big sellers, generating billions of dollars for pharmaceutical companies.

Under the FDA’s new guidance, which goes into effect immediately, drug makers will be required to provide evidence that their medications do not increase heart risks when compared with other available diabetes treatments. In addition, manufacturers will need to have any heart events that occur in their clinical trials analyzed by a committee of outside cardiologists, who are unaware of whether the subject received the new drug or a placebo.

“Based on these evaluations, the FDA can better ensure that product labeling includes comprehensive information on safety and effectiveness,” said the regulatory agency in a statement released December 17, 2008. “This will enable prescribers and patients to make better-informed decisions on the management of type 2 diabetes.”

At this time, it is unclear what impact the new FDA guidance on diabetes drug heart risks will have on medications like Avandia which are already approved and on the market. In recent months, there has been a growing call for the FDA to issue an Avandia recall due to a number of side effects, which appear to greatly outweigh any potential benefits provided over other drugs.

In the FDA statement announcing the new policy, the agency indicated that they are confident that current diabetes drugs that are on the market are safe and effective when used according to the approved labeling. However, the agency also indicated that they are continuing to evaluate how their recommendations for new drugs will be applied to medications already on the market.