A newly published study is raising concerns that patients who take Actos or Avandia may face an increased risk of developing diabetic macular edema, an eye disorder that can result in vision loss. The study, published in the Archives of Internal Medicine, found that type 2 diabetics who use thiazolidinediones, a group of drugs that includes Actos and Avandia, had a two to three times higher risk of macular edema. The risk was higher if patients used insulin in combination with the drugs.
According to a report from The New York Times, macular edema involves swelling in the central part of the retina. The condition can result in blindness in one or both eyes. Several small studies and case reports have pointed to an association between Actos and Avandia and the eye disease, but the Archives of Internal Medicine study is the largest to ever investigate a possible connection, the Times said.
For the study, researchers in the U.K. followed more than 100,000 people with type 2 diabetes included in the British Health Improvement Network database for a decade. None of the subjects suffered from diabetic macular edema at the start of the study. After one year, 1.3 percent of patients taking thiazolidinedione developed diabetic macular edema, compared with 0.2 percent of those not taking these drugs. The association was seen whether patients were taking Actos or Avandia.
While the findings don’t prove that Actors or Avandia cause macular edema, the study authors said the study highlights the importance of regular vision checks for diabetics.
About Actos and Avandia
Both Actos and Avandia have been linked to other serious side effects. Most recently, Actos raised concerns that it could significantly increase the risk of bladder cancer in people who used it long-term. Last summer, the U.S. Food & Drug Administration (FDA) issued a safety communication stating that use of Actos for more than one year may be associated with an increased risk of bladder cancer. When compared to persons never treated with Actos, taking the drug for more than 12 months was associated with a 40 percent increase in the risk of developing bladder cancer, the agency said. The FDA mandated that new information about this risk be added to the “Warnings and Precautions” section of the Actos label. Bladder cancer concerns also led to sales of the drug being suspended in Germany last summer, and the drug was officially recalled from the market in France.
Lawsuits alleging Actos caused bladder cancer and other serious health problems have been consolidated in a multidistrict litigation in U.S. District Court, Western District of Louisiana before the Honorable Rebecca Doherty (Re: Actos Products Liability Litigation, MDL 2299). Some legal experts believe that Takeda Pharmaceuticals, the maker of Actos, could eventually be named in as many as 10,000 Actos side effect lawsuits.
Since November 2007, Avandia’s U.S. label has included a black box warning detailing its association with heart attacks. In 2010, the FDA placed severe restrictions on sales of Avandia, after determining its heart risks outweighed its benefits. More than 2,500 Avandia lawsuits have been consolidated before U.S. District Judge Cynthia Rufe in Avandia Marketing, Sales Practices and Products Liability Litigation (MDL No. 01871), U.S. District Court, Eastern District of Pennsylvania, Philadelphia.