A new Scottish study finds that diabetes patients taking the group of diabetes drugs that includes Actos are at increased risk of suffering hip fractures.
The University of Dundee researchers said bone fractures are “a severe adverse effect” for users of the class of diabetes drugs containing the active ingredients pioglitazone or rosiglitazone. The study of diabetes drug side effects appears in the November issue of Diabetologia, the journal of the European Association for the Study of Diabetes.
The study adds to the concerns about drugs containing pioglitazone, such as Actos, which the FDA has warned may increase the risk of bladder cancer among long-term Actos users. Actos is a medication prescribed to treat patients with Type 2 diabetes.
The researchers analyzed a nationwide database and calculated the rate of hip fractures among more than 37,000 diabetics who were taking Actos and other diabetes drugs in the class of medications called thiazolidinediones or TZDs. Determining whether TZDs increase the risk of hip fractures more than other diabetes medications is important, given the high rates of mortality associated with hip fractures, the researchers said.
The researchers observed that the risk of hip fractures increased by 18 percent for both men and women for each cumulative year of exposure to Actos and other TZD drugs.
The researchers said that the drug’s current label mentions the risk of bone fractures, but emphasizes distal fractures (as opposed to hip fractures) and states that the risk applies mostly to women. The researchers say the warning label should be revised to reflect the accumulated data about hip fractures and the risk to men as well as women.
“Hip fracture should be considered at least as important a potential adverse effect of pioglitazone as bladder cancer,” the researchers concluded.
Last year, the Food and Drug Administration issued a safety warning that long-term users of Actos, which contains the active ingredient pioglitazone, have a higher risk of bladder cancer. Since then, hundreds of patients using Actos have reported the development of bladder cancer.
Pharmaceutical companies have a legal responsibility to make and market medications that are safe and effective and to provide adequate warnings of harmful side effects. If you are a diabetic who has been taking Actos and developed bladder cancer, you may be eligible for compensation that can help pay your medical bills and relieve the financial burden of cancer treatment.
I’ve devoted my law practice to assisting people harmed by unsafe prescription drugs and medical devices. I’d like to help you if you’ve suffered a serious side effect from Actos.