Actos Hip Fracture Warnings Should Be Updated Due to Severe Risk: Study

The warning label for the popular diabetes drug Actos, as well as the already heavily restricted drug Avandia, should be updated to include stronger warnings about a potential increased risk of hip fractures, according to a group of Scottish researchers. 

In a study published earlier this month in the medical journal Diabetologia, researchers indicate that the link between the two diabetes drugs and hip fractures is stronger than previous studies indicated.

Actos and Avandia are both part of a family of medications known as thiazolidinediones (TZDs), and the study suggests that the hip fracture risk is likely common throughout the class.

As a result of the serious consequences that may be experienced by diabetics who suffer a hip fracture, researchers concluded that the existing warnings about the risk of fractures with Actos and Avandia should be updated.

Both drugs are already under heavy scrutiny, due to serious and potentially life-threatening risks associated with their use. Side effects of Actos have been linked to an increased risk of bladder cancer after long-term use and U.S. regulators have restricted access to Avandia due to the potential heart risks associated with that medication.

In this latest study, researchers looked at 37,479 people who took Actos or Avandia from 1999 to 2008. They discovered that the risk of hip fracture increased over time for both men and women who took the drugs, and there was little difference in the risk of hip fracture between the two medications.

Overall, the researchers determined that there was an 18% relative increase in hip fracture rates among Actos and Avandia users for every cumulative year they were on the diabetes drugs. An important part of the study was showing that the hip fracture risk affected men as well. Previous studies have focused on the risks involving female users of the drugs.

“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 study comes as GlaxoSmithKline agreed to pay $90 million to settle Avandia heart attack lawsuits brought by 38 states claiming that the company deceived their Medicare programs by not honestly reporting the drug’s safety risks. The company has paid more than $1 billion in Avandia settlements, covering more than 25,000 lawsuits brought on behalf of former users who suffered an injury allegedly caused by the diabetes drug.

Takeda Pharmaceuticals, the makers of the popular diabetes drug, faces more than 1,000 Actos lawsuits filed in state and federal courts throughout the United States, and many expect that there may be more than 10,000 complaints ultimately filed by individuals who allege the drug maker failed to adequately warn about the risk of developing bladder cancer while taking Actos.