Actoplus Met XR is an extended-release, once-daily pill taken to help control blood sugar levels in adults with Type-2 Diabetes. It contains two anti-diabetic medications: pioglitazone and metformin. These medications help control blood sugar by increasing the body’s sensitivity to insulin, and also decreasing the amount of sugar (glucose) released by the liver. Unfortunately, the pioglitazone found in Actoplus Met XR (and Actos, Actoplus Met, and Duetact) may increase a user’s risk of bladder cancer by 40%. Other Actoplus Met XR side effects include heart attacks, stroke, bone fractures, macular edema, and more.
Do I Have an Actoplus Met XR Lawsuit? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one has been injured after taking Actoplus Met XR, you should contact our lawyers immediately. You may be entitled to compensation by filing an Actoplus Met XR lawsuit.
UPDATE: $9 Billion Award in Louisiana Actos Bladder Cancer Lawsuit
April 8, 2014 – In the seventh-largest jury verdict in U.S. history, Takeda and Eli Lilly have been ordered to pay $9 billion in punitive damages for failing to warn about the risk of bladder cancer. Judge Rebecca Doherty, who also oversees more than 2,700 Actos lawsuits, penalized the companies for destroying thousands of documents on over 40 employees involved in development and sales of Actos. Click here to read more.
Actoplus Met XR Overview
Actoplus Met XR is a medication that helps control blood sugar levels in adults with Type-2 Diabetes, in combination with diet and exercise. Actoplus Met XR is an extended-release, once-daily pill, created by Takeda Pharmaceutical Company Limited. Actoplus Met XR was approved by the U.S. Food and Drug Administration (FDA) on May 13, 2009.
Actoplus Met XR contains two diabetes medications:
- Actos (pioglitazone): This medication belongs to a class of anti-diabetic drugs called thiazolidinediones (TZDs), which increases the body’s sensitivity to insulin. It is also the ingredient in Actoplus Met XR that has been linked to bladder cancer, heart attacks, and other severe side effects.
- Metformin: This medication helps a diabetic person control the amount of sugar (glucose) in the bloodstream. It decreases the amount of glucose that the body can absorb from food, decreases the amount of glucose created by the liver, and increases the body’s sensitivity to insulin.
Actoplus Met XR is very similar to Actoplus Met. The difference is that Actoplus Met XR only needs to be taken once per day. It contains extended-release metformin, a novel form of the drug that was developed by Watson Laboratories. Most people switch to Actoplus Met XR after using Actos or metformin alone, and find that these medications alone do not control their blood sugar very well.
Type-2 Diabetes is a chronic metabolic disorder that can become progressively worse over time without treatment. It is a relatively common disorder, affecting around 24 million Americans. It occurs when the body becomes insulin resistant, which causes poor blood sugar control. Insulin is a hormone secreted into the bloodstream by the pancreas whenever a person eats food. Sugars in food are converted into glucose by the liver, and released into the bloodstream. Insulin tells cells in the body to stop using energy from reserved sources, and start absorbing sugar (glucose) from the bloodstream. Type-2 Diabetes occurs when cells in the body become less sensitive to insulin, and as a result, they do not absorb enough glucose from the bloodstream. This can cause high blood sugar, which can cause life-threatening complications. Many people must treat Type-2 Diabetes with diet and exercise, insulin injections, and medications such as Actoplus Met XR.
FDA Warning: Actoplus Met XR Linked to Bladder Cancer
One condition of FDA approval in the U.S. is that drug companies must conduct post-marketing safety research to determine whether the product is causing side effects that were not anticipated when the drug was initially approved.
Takeda, the drug company responsible for Actoplus Met XR, is currently conducting a ten-year post-marketing study that involves around 200,000 people taking Actos. When the FDA reviewed results at the five-year halfway point, they found that among people who had taken Actos for at least one year, bladder cancer was 40% more likely.
As a result, the FDA issued a Drug Safety Communication, and stated:
“Compared to never being exposed to pioglitazone, a duration of pioglitazone therapy longer than 12 months was associated with a 40% increase in risk . . . Based upon this data, FDA calculated that duration of therapy longer than 12 months was associated with 27.5 excess cases of bladder cancer per 100,000 person-years follow-up, compared to never using pioglitazone.”
France and Germany Ban Actoplus Met XR
The FDA is not the only health organization to become alarmed at the link between Actos and bladder cancer. French researchers also compared the incidence of bladder cancer in 155,000 Actos patients, compared with 1.3 million non-Actos patients, between 2006 and 2009. The group of people taking Actos were 1.2-times more likely to develop bladder cancer. When the sample size was limited to people who had taken Actos for at least 24 months, they were 1.4-times more likely to develop bladder cancer.
In response, French and German drug regulators ordered doctors to stop prescribing Actos and any medications combined with Actos, including Actoplus Met XR. Both countries have suspended sales of the medication.
Actoplus Met XR Side Effects
Bladder cancer is one of the most severe side effects of using Actoplus Met XR. Like most cancers, bladder cancer is potentially life-threatening if it is not diagnosed early during the disease. It begins in the “transitional cells” in the lining of the bladder, called the endothelium. However, it is not typically diagnosed until it grows into the muscular wall of the bladder, because it begins causing extreme pain during urination and may also cause blood in the urine. If it is diagnosed at this early stage, prognosis is relatively good and there are several good treatment options. A surgeon may remove cancerous tissue. Chemotherapy is often used in conjunction with surgery. Bladder cancer is also one of a few cancers where researchers have developed novel immunotherapies. By injecting the Bacille Calmette-Guerin vaccine inside the bladder, it can trigger a person’s own immune system to attack bladder cancer. However, if bladder is not diagnosed early, or if treatment fails, the cancer can spread to tissues and organs surrounding the bladder. Once the cancer spreads, it has “metastasized,” and survival and cure rates drop significantly.
Other serious Actoplus Met XR side effects include, but are not limited to:
- Cardiovascular problems
- Heart attack
- Bone fractures
- Liver problems
- Fluid retention
- Weight gain
- Macular Edema
- Congestive Heart failure
- Low red blood cell count (anemia)
- Low blood sugar (hypoglycemia)
Do I have an Actoplus Met XR Lawsuit?
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