Two Diabetes Medications Double Fracture Risks in Women

-HealthNews

12/14/2008- If you have diabetes you might want to ask your physician to review the risks of the medications before taking them. Two widely prescribed medication for diabetes, Actos and Avandia, have both been shown to double the risk of fractures among women. The fracture risk did not increas for men.

The medications Actos (pioglitazone) and Avandia (rosiglitazone) are commonly used for lowering blood sugar in patients that have type 2 diabetes. There are approximately 4 million people in the United States who take these medications, which are called thizolidinediones. Recent studies suggest that the risk for heart attack, heart failure, and death were increased with the drug Avandia, touching off of a controversy that resulted in a new U.S. Food and Drug Administration-mandated label warnings about the medication.

The lead researcher on this new fracture study, Dr. Yoon Loke, clinical senior lecturer at the University of East Anglia in Norwich, stated, “Women who are taking these drugs should reconsider the options. 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.”

Loke’s research team evaluated ten trials that included 13,715 diabetics taking Actos, Avandia, or neither medication for the meta-analysis. These studies found that these medications reduced the bone density in the hips and spine of women that were taking these drugs.

The researchers estimated that this loss of bone density would almost double the fracture risk in women taking either medication. For the women that were already at risk for fractures, the researchers estimated that one fracture would occur for every 21 women, and for those women that were at a low risk for fractures, one fracture would occur in 55 women taking these medications.

However, there was no effect on bone density among men in any of the studies that the researchers analyzed. Loke speculated that women were affected by the drugs differently because of an interaction between estrogen and the medication, which can weaken bones in women. The difference may also result from women having smaller, thinner bones at the outset, so that even a loss of a small amount of bone mass can increase the risk of having a fracture.

Loke stated that these medications should have stronger warnings about potential side effects, saying. “The U.S. Food and Drug Administration needs to give a much stronger warning to women. And the warning should be that really these drugs should be avoided if at all possible.”

Dr. Lorraine Lipscombe, of the University of Toronto in Canada, stated that she thinks this study raises more concerns about the use of these medications. This evidence has been added to the growing concern regarding these medications, which have also been associated with a higher risk for heart attacks and possibly heart failure. Because medications for diabetes are typically approved based on their effects on sugar control rather that long-term outcomes, these adverse effects have only emerged after the medications are already on the shelves to be sold.

There is still not enough evidence at this moment to the clinical benefit of these medications, aside from lowering blood sugar, therefore the use of these medications in treatment for diabetes is unclear. Lipscombe said, “Because clinical trails are designed to assess the expected effects of drugs, they often don’t have enough power to detect unexpected or less common effects. Therefore, a more standardized post-marketing surveillance process is needed to ensure that potential adverse effects are recognized as early as possible.”

GlaxoSmithKline, the make of the drug Avandia, said that this study rehashes something that is already known and reflected on its label. In addition, GlaxoSmithKine stands behind this medication as being a safe and effective treatment for type 2 diabetes that is appropriate for the patient.

It has been previously reported that there has been an association with thiazolidinediones and bone fracture. The labeling for pioglitazone and rosiglitazone notes that the observation of an increased incidence of bone fractures in women taking the drugs.

If you or a loved one have experienced an Avandia heart attack, or Avandia stroke, Avandia congestive heart failure, Avandia cardiovascular disease or if you have lost a loved one to an Avandia death you may be entitled to compensation. Contact the Avandia attorneys of Ennis & Ennis today for a free confidential case evaluation. Our on staff nurse and lawyers are standing by to answer any questions you may have regarding Avandia's side effects, a possible Avandia class action lawsuit, or any other type of Avandia litigation.