Researchers Call For Stronger Actos, Avandia Hip Fracture Warnings

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November 28, 2012 – Earlier this month, a Scottish research team said that labels of the widely-prescribed diabetes drugs Actos and Avandia should be updated to include stronger warnings about an increased risk of hip fractures. A study conducted by the team found that the link between the two drugs and hip fractures is significantly stronger than previous studies have indicated. In addition to being linked to hip fractures, both Actos and Avandia have been reported to cause bladder cancer, macular edema, and heart problems.

What’s the problem?

The Scottish study, which was published in the medical journal Diabetologia, involved a cohort of 37,479 test subjects who took Actos or Avandia between 1999 and 2008. The researchers found that the risk of hip fractures increased incrementally over time for both males and females who took the medications, and that there was little overall difference in the risk between Actos and Avandia. Taking the results of the study into consideration, the researchers concluded that current warning labels for the drugs were inadequate and needed updating.

Both Actos and Avandia, which belong to a controversial class of medications known as thiazolidinediones (TZDs), have faced increased scrutiny over the past several years after being linked to a host of serious side effects. In addition to fractures, complications associated with the drugs have been reported to include:

  • congestive heart failure (CHF)
  • heart attack
  • stroke
  • liver problems
  • bladder cancer
  • macular edema

The latest study found that there was an 18% increase in hip fracture rates among Actos and Avandia users for every cumulative year they were on the drugs. A crucial aspect of the research focused on showing that the hip fracture risk affected men as well as women. Previous studies have tended to focus the fracture risk primarily on female patients.

“Current TZD drug labels state that ‘the risk of fracture should be considered’ but emphasise that effects are on distal fracture and mostly in women,” the researchers concluded. “These labels should be changed to reflect the accumulated data on hip fracture and risk in men.”

The new research comes on the heels of news that pharmaceutical giant GlaxoSmithKline (GSK) has agreed to pay $90 million to settle Avandia heart attack lawsuits filed in 38 states which claim that the company deceived Medicare programs by withholding information about the drug’s serious side effects. GSK has already shelled out over $1 billion in Avandia settlements to cover more than 25,000 lawsuits brought on behalf of former users who were allegedly injured by the drug.

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