Actos (pioglitazone) is a diabetes drug approved by the U.S. Food and Drug Administration in 1999. You or someone you care about may have been prescribed Actos control blood sugar levels in Type 2 diabetes. It works by decreasing your insulin resistance, as well as decreasing glucose levels in your body. Unfortunately, it has been linked to serious medical conditions. Many of these conditions are life-threatening. The most serious side effects are congestive heart failure and bladder cancer. Other side effects include the risk of bone fracture, chronic kidney disease, and liver failure.
Concerns linking Actos to bladder cancer began several years ago. In 2011, the FDA required that the drug carry a warning that taking it may lead to an increased risk of bladder cancer. A 2012 article published in the BMJ (British Medical Journal) found that using it for a lengthy period of time could increase the risk of developing bladder cancer by eighty-three (83%) percent. Other studies have shown similar findings.
Congestive heart failure (CHF) is another serious side-effect of Actos. A black-box warning was required by the FDA to warn users of the possible risk of developing or worsening CHF. The black box warning states that some patients with known heart failure should not take the drug because the medication may increase the risk of developing or worsening heart failure.
Several medical studies have identified Actos as a drug that can cause bladder cancer. If you have been diagnosed, you should contact an Actos lawyer to discuss your legal rights.
The U.S. Food and Drug Administration has publicly acknowledged a relationship between Actos and bladder cancer, claiming that taking the drug for over one year may be associated with a heightened risk of bladder cancer. The risk has grown to such a degree that all Actos prescriptions must be labeled with a warning about the risk of bladder cancer.
A five-year review of medical data showed that while Actos use did not carry an overall risk increase of bladder cancer, an increased risk was reported among long-term users. The medical data observation will continue for an additional five years as a ten-year epidemiological study.
European countries have followed suit with France and Germany suspending drug use or recommending that no new prescriptions be issued, respectively.
The FDA has recommended that current or past sufferers of bladder cancer refrain from using Actos and that any health complication symptoms be reported to your doctor immediately.
Actos Recall Information
The U.S. Food and Drug Administration (FDA) has not yet issued a recall for Actos despite the fact that the drug has been banned in several European countries. The drug is linked to very serious side effects, including bladder cancer and congestive heart failure. The FDA is still reviewing data and scientific studies to determine if it should be recalled from the market.
Even though it was not recalled, you can still pursue a lawsuit if you or someone has been harmed by Actos with the help of an attorney.
Actos & Bladder Cancer
Several studies have identified Actos as a drug that can cause bladder cancer. After a French study in 2011, the drug was banned from sale in France. Germany soon followed and also banned Actos. It is strongly recommended that anyone dealing with bladder cancer, or who has a history of bladder cancer, should not take Actos. If you suspect your diagnosis is related to Actos, however, you should contact a lawyer right away.
Bladder cancer is a form of cancer that begins developing in an individual’s bladder. The bladder, a hollow organ in the lower abdomen, is the organ responsible for the storing of urine until it is able to pass through the body.
Cancer often begins developing in the cells that line the interior of the bladder and occurs most commonly in older adults. When detected at an early stage, bladder cancer is highly treatable. However, it is one of the most recurring cancers and can require follow-up testing for the foreseeable future even if the initial cancer was eradicated.
There are three different forms of bladder cancer that depend on the initial location of the cancer development. The most common of these forms is transitional cell carcinoma which begins in the bladders urothelial cells. These are cells that change shape and stretch when the bladder is full.
Other forms of bladder cancer are squamous cell carcinoma and adenocarcinoma which begin in flat cells lining the bladder and the cells that make and release fluids, respectively.
With almost 77,000 cases of bladder cancer diagnosed in the United States each year, the American Cancer Society reports that it constitutes 5% of all new cancer cases and is the fourth most common cancer found in men.
Society also reports that almost 90% of all bladder cancer cases are found in those over the age 55 with the average diagnosed age being 73.
Bladder Cancer Symptoms
There are several common symptoms. These include:
- Having blood in your urine
- Needing to urinate suddenly
- Having pain when urinating
- Urinating more often than usual
Your doctor will need to perform a physical exam and may also order testing. Types of testing used to diagnose bladder cancer include a cystoscopy, urine cultures, and a bladder biopsy. Radiology studies like an MRI or CT scan may also be used to provide more specific information about cancer.
Your cancer can be treated in different ways. Each treatment has possible side effects and complications. The treatment that your doctor recommends depends on the stage of your cancer. The main types of treatment for cancer of the bladder are:
- Invtravescial therapy
- Radiation therapy
Actos & Congestive Heart Failure
Patients with heart problems are at risk of developing Congestive heart failure (CHF) from using Actos. The FDA required a black-box warning to warn Actos users of the possible risk of developing or worsening CHF. The warning states that some patients with known heart failure should not take Actos because the medication may increase the risk of developing or worsening heart failure.
Discovery Rule and Settlements
The exact statute of limitations to bring a claim varies by state. In negligence cases, it is generally two years. But the limitation period is not always 730 days. The limitation period is “tolled,” which means the clock stops ticking until the plaintiff knows about the injury and knows about the possible negligence that could have caused the injury. Consider the following hypothetical timeline:
- 2011 – Patient begins taking Actos
- 2013 – Patient starts experiencing bladder cancer symptoms, but is not diagnosed
- 2014 – Patient is diagnosed with bladder cancer
- 2015 – The FDA changes the warning label to reflect the known link between Actos and bladder cancer, but since the patient is no longer taking the medicine, the patient does not actually know about the change
- 2016 – Patient sees a lawyer’s television commercial advising viewers of the risks of Actos
Arguably, any one of these events could be a trigger that starts or stops the statute of limitations clock. The bottom line is that, if you or a loved one was injured while ingesting a dangerous drug, time is not on your side.
Settlements have not yet been paid but recent huge jury verdicts in cases suggest that patients diagnosed with bladder cancer after using Actos will receive significant compensation. Although some cases may go to a trial, the majority of Actos cases will settle before a trial.
The Actos settlement amounts will be eventually determined by a number of factors that can be explained by a knowledgeable lawyer. These include the amount of money designated by the drug company to pay these claims, the number of total claimants, and the injury or harm suffered by a claimant. Claimants are often put into settlement categories based upon the type of injury and the strength of their case.
Our Actos Attorneys Can Help You
Retain the Actos lawyers at Drug Lawsuit Source to demand justice for your injuries or worsened medical condition from taking this drug.