Personal Injury Law

Avandia, Actos May Impact Bone Density In Women

By Jane Akre

The widely prescribed diabetes drugs Avandia and Actos have been in the news lately because of concerns about the risk for heart failure.

Now a British analysis finds Avandia and Actos double the risk of fractures in women, not in men.

Avandia, also known as rosiglitazone, and Actos, also known as pioglitazone, lower blood sugar in diabetic patients. "Women who are taking these drugs should reconsider the options," said lead researcher Dr. Yoon Loke, a clinical senior lecturer at the University of East Anglia in Norwich.

"There are quite a lot of choices for women with type 2 diabetes. I am not sure that taking a drug that causes fractures is the best choice."

For the study, Dr. Loke and his team evaluated ten trials in which the participants were taking both drugs or neither. Across the board, they found a reduction in hip and spine bone density in women on the medications.

Interestingly, there was no corresponding effect on the bone density of men, probably because of some interaction with estrogen.  A loss of bone mass puts a person at an increased risk of fracture.

Researchers estimate that could occur once in every 21 women who are already at risk for fractures. The number more than doubles for women who are not at risk or who have a low risk.

Dr. Loke believes that a stronger warning should be placed on the drug label by the Food and Drug Administration (FDA). "And the warning should be that really these drugs should be avoided if at all possible," he said to the Washington Post.

The report is published online by the Canadian Medical Association Journal.

Approximately four million people in the U.S. take Avandia and Actos made by GlaxoSmithKline. The company says Avandia is "a safe and effective treatment for type 2 diabetes for the appropriate patient."  

The new research has been previously reported and rehashes what's already on the label says GSM spokesman Jeff McLaughlin to the Washington Post.

But the efficacy in the treatment of type-2 diabetes is still unclear.

In November 2007, the FDA required Avandia to carry a black box" warning, the strongest that appears on a drug label, to caution about the increased risk of heart attack.  A report in the May 2007 New England Journal of Medicine found a 43 percent increase in the risk of heart attack compared to a control group.

Last October, Public Citizen petitioned the FDA for an immediate ban of the drug Avandia because it can cause death from liver failure and many other life-threatening risks that far outweigh its benefits.

While reviewing U.S. Food and Drug Administration data, the group found 14 unpublished cases of severe drug-induced liver failure, including 12 deaths.

Older drugs for type 2 diabetes are considered safer such as: Glucophage (generic name metformin) and Glucotrol (generic name glipizide). #

Full post as published by InjuryBoard on December 10, 2008 (boomark / email).