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Class Of Diabetes Drugs That Includes Avandia Linked To Fracture Risk
Sep 30, 2009 | Parker Waichman Alonso LLP
The risk of bone fracture in individuals taking thiazolidinediones has again been suggested in another recent study. Science Daily just reported that research published this week in PLoS Medicine discussed the risk between the type 2 diabetes drugs and bone fracture. Thiazolidinediones—known as TZDs—were introduced in the 1990s and include such popular medications as Avandia (rosiglitazone) or Actos (pioglitazone).The study, led by Ian Douglas of the London School of Hygiene and Tropical Medicine—reviewed, said Science Daily, the General Practice Research Database, which is a listing of clinical records of over six million patients registered at 400 general practice surgeries in the United Kingdom.
The team located 1,819 patients aged 40 and older with a recorded bone fracture and who were also prescribed a TZD at least once. The team conducted a “self-controlled case-series study,” which compares the frequency of the event—a fracture—in a demographic over a certain time and when a specific medication—TZDs—is taken versus when the medication is not taken, explained Science Daily. The group was age-adjusted to allow for age-related fractures.
The study revealed that about one and half times as many fractures were reported when people took TZDs versus when TZDs were not taken, said Science Daily. The increased fracture risk occurred in both men and women and affected an array of body areas, reported Science Daily, which also noted that the risk was commensurate with the duration of treatment.
The team concluded that the study’s main advantage was that it removed the potential for differences between those who do and do not take a specific drug, said Science Daily, and that these findings are consistent with others studies in which the TZD-fracture connection was found. The researchers stated that the results "should be taken into consideration in the wider debate surrounding the possible risks and benefits of treatment with thiazolidinediones,” quoted Science Daily.
In August we reported on a large, panel study that also revealed an increased risk of fracture associated with TZDs. That study took place in British Columbia, Canada, and appeared in the Archives of Internal Medicine, according to The Heart. That research team looked at fracture risk in over 84,000 patients who received Avandia or Actos over a sulfonylurea, said The Heart. 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 & Drug Administration (FDA) asked for a warning on the Actos labeling two years ago to address the risk, noted the Heart. As with the British study, this study found that the risk for fractures increased the longer the patient was on the medication.
In addition to its potential to cause fractures, Avandia has been linked to a long list of other safety concerns. In July we wrote that a prominent consumer advocacy group found that Avandia was associated with death due to liver failure. In June, we wrote about a published Avandia study that found the drug “significantly” raises the risk of heart failure and fractures. 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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