In what appears to be the latest blow to Takeda’s controversial diabetes medication Actos, British researchers have announced new information indicating that the drug may increase the risk of macular edema in diabetics who fail to keep their blood sugar under control. Actos has also recently been linked to an increased risk for bladder cancer, prompting nationwide recalls in both France and Germany. Here at home in the United States, Actos remains widely used and is Takeda’s best selling drug, with sales of some $3.4 billion in 2010 alone.
Actos Macular Edema Update 6/14/12: According to the results of a new study published in the Archives of Internal Medicine, using Actos may significantly increase the risk of developing a severe eye problem known as macular edema. This condition causes the macula region of the eye to swell, leading to a loss of visual acuity. Click here to learn more.
Free Actos Case Evaluation: If you or a loved one has developed macular edema, bladder cancer or any other serious side effect after using Actos, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.
What’s the problem?
June 27, 2011 – The new study, which was presented by researchers from the University of Nottingham at the American Diabetes Association’s 2011 Annual Meeting, indicated that Actos (pioglitazone) could increase the risk of macular edema, an extremely serious condition that can lead to blindness. The research also implicated Avandia, a similar drug in the same class that has been under heavy scrutiny due to concerns about an increased risk of heart attacks and death in certain users.
The study involved more than 100,000 diabetic patients living in the U.K., and was divided between individuals who had taken Actos or Avandia and those who had not. The cumulative results found that 1.3% of those who took either drug developed macular edema after 12 months of use, compared to just 0.2% of those from the control group who took no such medications. Taking these figures into consideration, the risk of diabetic macular edema increased three to six times among people who used Actos or Avandia.
Actos Macular Edema
Macular edema is characterized by a swelling or thickening of the eye’s macula, the part of the eye that is responsible for detailed vision. The macula lies at the center of the retina, a thin layer of light-sensitive tissue that lines the back of the eye. When light rays are focused onto the retina, they are transmitted to the brain and interpreted as real world images. It is the macula that allows a person to pinpoint his or her vision and concentrate on fine motor activities such as reading, sewing or recognizing people’s faces. Signs and symptoms of Actos-induced macular edema may include (but are not limited to):
- straight lines appear wavy
- blurred central vision
- sensitivity to light
- pink tint to one’s vision
The first line of treatment for macular edema is typically anti-inflammatory drops. In more advanced cases of the condition, medication may be injected near the back of the eye for a more concentrated effect. Oral drugs may also be prescribed to reduce the swelling.
Actos Bladder Cancer
In June 2011, the FDA issued a press release warning that Actos may increase the risk of bladder cancer in users who take the drug for an extended period of one year or more. The warning came less than a week after Germany and France banned the drugs over similar concerns. “Compared to never being exposed to pioglitazone, a duration of pioglitazone therapy longer than 12 months was associated with a 40 percent increase in risk [for bladder cancer],” the agency said.
Bladder cancer begins when normal cells in the bladder begin to change and grow uncontrollably, resulting in a mass called a tumor. A tumor can be benign (noncancerous) or malignant, meaning that it can spread to other parts of the body. Potential signs and symptoms of Actos-induced bladder cancer include:
- needing to urinate without results
- pain while urinating
- blood found in the urine
- frequent urination
FDA has advised healthcare professionals not to prescribe Actos to individuals with bladder cancer, and to use it with extreme caution in patients who have had bladder cancer in the past. Additionally, the FDA has stated that “the benefits of blood sugar control with pioglitazone should be weighed against the unknown risks for cancer recurrence.”
The administration is also requiring that new warnings about the risk of bladder cancer from Actos be added to the Warnings and Precautions section of the drug’s labeling. Similar warnings will also be added to other medications that contain pioglitazone including Actoplus Met, ActoplusMet XR and Duetact.
Do I have an Actos Macular Edema Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Actos lawsuits. We are handling individual litigation nationwide and currently accepting new macular edema cases in all 50 states.