Actos, Avandia Bone Fracture Risk Seen In Another Study

Another large, panel study has revealed an increased risk of fracture associated with thiazolidinediones (TZDs), which are used to treat type 2 diabetes. The study, which took place in British Columbia, Canada, appears in the August 10/24, 2009 issue of the Archives of Internal Medicine, said The Heart. TZDs are a class of diabetes drugs that includes <"">Avandia and <"">Actos.

The study, said the Heart, looked at fracture risk in over 84,000 patients who received Avandia (rosiglitazone) or Actos (pioglitazone) over a sulfonylurea. The study revealed that men and women experienced an increased risk of fractures when taking a TZD and found that Actos could actually be responsible for an increased fracture risk, said the Heart.

The U.S. Food and Drug Administration (FDA) asked for a warning on the Actos labeling two years ago to address the fracture risk, noted the Heart.

According to Dr. Colin R Dormuth, of the University of British Columbia, Vancouver, and his colleagues, “Larger observational studies are needed, and fracture data from clinical trials need to be fully published so that fracture risks can be known with greater certainty,” quoted the Heart. The study, which might be the largest of its kind, to date, found the TZDs were linked to a 28 percent increased risk of peripheral fractures in both genders, versus treatment with sulfonylurea. The risk was higher in women (77 percent) and men (61 percent) for pioglitazone versus rosiglitazone, said the Heart.

The study found that the risk for fractures increased the longer the patient was on the medication and that 86 patients would have to be on TZD for three years to experience an additional peripheral fracture, said the Heart. “Our findings suggest that both men and women are at increased risk of fracture as a result of exposure to TZDs and that pioglitazone treatment may be more strongly associated with fractures than rosiglitazone treatment,” said the team, quoted the Heart. “Prescribers of these medications should therefore not assume that fracture risk is confined to women who take rosiglitazone,” the team added.

Avandia has been focus of safety concerns in the past. In July we reported that a prominent consumer advocacy group had found that Avandia had been associated with death as a result of liver failure, and should be banned by the FDA. The group, Public Citizen, published the research in the peer-reviewed medical journal Pharmacoepidemiology and Drug Safety. According to Public Citizen, it petitioned the FDA to ban Avandia as far back as October due to its risks, including heart attack, heart failure, and liver toxicity, noting that these risks “far outweigh its benefits,” especially given that there are safer medical alternatives for the treatment of Type 2 diabetes. The study discussed 11 cases of severe liver toxicity, mostly fatal, that were associated with Avandia (generic: rosiglitazone) use, said Public Citizen.

In June, we wrote about a published Avandia study that found the drug “significantly” raises the risk of heart failure and fractures. Unlike previous research, the study did not find that people taking Avandia were at a higher risk of heart death, and was unable to determine if the Avandia patients in the study had a higher chance of heart attack. According to a report on WebMD, the study—known as RECORD—caused some controversy because GlaxoSmithKline funded it.

Avandia’s cardiovascular side effects first became the subject of concern in May 2007, when an analysis of 42 clinical trails published by the Cleveland Clinic showed that patients taking the drug had a 43-percent higher risk of having a heart attack. That summer, GlaxoSmithKline and the FDA came under fire for an apparent failure to warn the public about the cardiac risks associated with Avandia. In November 2007, a warning detailing Avandia’s association with myocardial ischemia was added to the drug’s boxed warning.

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