Personal Injury Law

New Studies About Avandia And Actos Side Effects Other Than Cardiovascular Conditions

By Tom Lamb

Glitazone Class Of Diabetes Drugs Can Increase The Risk Of Bone Fractures And Diabetic Macular Edema

(Posted by Tom Lamb at DrugInjuryWatch.com)

In 2007 the FDA required a black-box warnings on the package insert, or label, of Avandia and Actos labels which states that these diabetes drugs should not be used in patients with advanced congestive heart failure (CHF). In addition, there have been several studies which show that Avandia may significantly increase the risk of having a heart attack, or myocardial infarction (MI).

While these cardiovascular conditions associated with the use of Avandia and Actos continue to receive most of the attention, there are some other serious side effects that have been linked to these diabetes drugs.

We start with a December 9, 2008 USA TODAY article, "Diabetes drugs double women's fracture risk"":

According to researchers at Wake Forest University School of Medicine who reviewed 10 previous drug trials, for every 20 women in their 70s with type 2 diabetes who took thiazolidinediones ? rosiglitgizone (brand name Avandia) and pioglitazone (brand name Actos) ? for at least one year, one of them has a chance of suffering a fracture. In women in their mid-50s, the figure equals one fracture in every 55 women. That's more than double the normal risk for those age groups.

The new research appears online in the Canadian Medical Association Journal this week. About 14,000 patients were involved in the studies analyzed by study co-author Sonal Singh, assistant professor of internal medicine at Wake Forest, and his colleagues.

The same increase in fractures was not found in men, says Singh, though the reason why was not determined.

The significance of this research is that while scientists already knew that thiazolidinedione (TZD) drugs for diabetes were associated with fractures, the magnitude of the risk had not been evaluated previously.  This Wake Forest study shows that Avandia and Actos double the risk of fractures in women with type 2 diabetes.

We move next to a press release that was issued earlier today, "Diabetes drug class linked to vision-threatening complication":

Treatment with the glitazone class of diabetes drugs leads to a "modest" increase in the risk of diabetic macular edema (DME)?a common complication that can lead to vision loss, reports a study in the April issue of the American Journal of Ophthalmology....

.... Diabetic macular edema is a common diabetes complication, with swelling and fluid build-up in the retina leading to progressive visual loss.

The researchers identified 996 patients who were diagnosed with DME during 2006. Overall, patients who took glitazones were 2.6 times more likely to develop DME than patients not taking these drugs. Even after further adjustment for other factors, DME risk remained 60 percent higher for glitazone users.

.... Most of the glitazone users in the study were taking pioglitazone (Actos). Other studies have linked rosiglitazone (Avandia)?the only other approved glitazone drug?to a possible increase in the risk of myocardial infarction.

The April 2, 2009 press release goes on to note that although this study is not the first study to suggest a link between the glitazone class of diabetes drug and the DME eye side effect, it provides confirmation in a very large sample of diabetic patients.

We will continue to monitor the safety profile of Avandia for further developments.

Full post as published by Drug Injury Watch on April 02, 2009 (boomark / email).