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Actos (generic name Pioglitazone) is an oral medication prescribed to patients suffering from Type 2 diabetes, and is not used to treat Type 1 diabetes. The drug  — manufactured by Takeda Pharmaceuticals — aids in controlling blood sugar levels in users along with diet and exercise.

Dosage for the drug typically begins at 15 or 30 mg, and is taken once a day. Although other patients may need a much stronger dose, to which doctors can increase by 15 mg boosts. The maximum dosage recommended for the drug is 45 mg.

Pioglitazone can be used on its own or in accordance with other Type 2 diabetes medications like metformin. The drug helps patients with Type 2 diabetes by:

  • Decreasing insulin resistance and decreasing the glucose produced in the liver
  • Allowing the body to better eliminate excess blood sugar
  • Making the body’s cells more sensitive to insulin

This drug was approved by the U.S. Food and Drug Administration (FDA) in 1999, and has been one of Takeda Pharmaceuticals’ best-selling drugs.

Patients with the following illnesses should not take pioglitazone:

  • Congestive heart failure
  • Hepatic (liver) effects
  • Bladder cancer
  • Macular edema
  • Edema
  • Fractures
  • Hypoglycemia
  • Macrovascular outcomes

Symptoms and Side Effects

Side effects from the use of the drug include stomach pain, blood in urine, painful urination, shortness of breath even during mild exertions, swelling or rapid weight gain, chest pain, nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colors stool, jaundice (yellowing of the skin or eyes), blurred vision, increased thirst or hunger, urination that occurs more frequently than usual, pale skin, easy bruising or bleeding, and weakness.

However, there are less serious common side effects such as cold symptoms (stuffy nose, sneezing, coughing, sore throat, sinus infection or sinus irritation, upper respiratory infection), headaches, general ill feeling, fevers or chills, unusual fatigue, unusual low blood sugar, gradual weight gain, muscle pain, back pain, and tooth problems.

Sometimes, allergic reaction may also happen while under this medication. Some symptoms include hives, difficulty breathing, and swelling of the face, lips, tongue or throat.

Actos also has several severe side effects, which could potentially be bladder cancer, congestive heart failure, chronic kidney disease, macular edema, lactic acidosis, heart attacks, liver damage, blindness, kidney damage and bone fractures.

Lawsuits and Litigation

Thousands of patients who have been adversely affected by the drug have already filed lawsuits against Takeda Pharmaceuticals and its marketer, Eli Lilly & Co., after plaintiffs were diagnosed with having bladder cancer.

A former shopkeeper in New York named Terrence Allen won the first federal trial against the drug’s manufacturer after obtaining bladder cancer from the use of Actos.

A Louisiana jury awarded Allen with $9 billion in punitive damages ($6 billion from Takeda, while $3 billion from Eli Lilly) in April 2014, following the plaintiff’s claim that the drug manufacturer “was more concerned with making money” than ensuring the drug to be safe for patient use. However, the award was then reduced to $37 million in October the same year.

Takeda Pharmaceuticals is currently in the midst of a multidistrict litigation (MDL), where several federal lawsuits are consolidated within one court for faster and more efficient proceedings.

Called the Multidistrict Litigation No. 2299, patients who plan to file a lawsuit can go directly to the U.S. District Court for the Western District of Louisiana, or any other lawyer who specializes in the drug’s litigation.

Even Dr. Helen Ge, a former safety consultant for the drug maker, filed a lawsuit against the company. Helen Ge alleges that Takeda concealed the drug’s side effects from the FDA.

Ge further noted that she received several reports of delirium, suicide, bladder cancer, and congestive heart failure, all of which were caused by the drug. Required to send side effect reports to the FDA, Ge was urged by her employer to ignore the reports, in addition to under-reporting the claims.

Furthermore, Dr. Ge states that the Takeda database obtained over 100 cases of bladder cancer, but only 72 were actually given to the FDA. Ge’s lawsuit has been dismissed.

It was only in April 2015 when Takeda Pharmaceuticals agreed to settle the thousands of claims regarding the drug that caused their bladder cancer. The settlement was worth – at the very least — $2.37 billion, which is one of the largest settlements with regard to pharmaceutical in the history of U.S. mass torts.

This Actos settlement is supposedly going to cover approximately 9,000 cases – giving each person who signs the settlement $275,000. However, the cost of the settlement agreement could grow into $2.7 billion.

Complaints allege that the company concealed the risk from both patients and doctors, in addition to failing to warn the public.

Here are some claims filed by plaintiffs against Takeda for Actos:

  • Failure to warn the public and health care providers that taking the drug for more than 12 months can heighten the risk of bladder cancer
  • Manufactured a defective product
  • Failed to properly test the drug
  • Concealment of testing and research data from the public
  • Giving misleading data to the public
  • Manufactured an unsafe product
  • Knew of the dangers of the product, but sold it to make profit
  • Breached warranty by marketing a drug that was not fit for use

On the other hand, here are the kinds of compensation that can be received by plaintiffs:

  • Punitive Damages: Punishing companies for misleading and failure to warn the public.
  • Medical and Funeral expenses: Lawsuits can cover the expenses for cost of treatment, checkups, surgery, medications, hospital bills, funeral expenses and the like.
  • Lost Income: When the individual is unable to go to work due to medical problems, they lose income. Caregivers may also lose time from work for caring for a loved one with medical problems.
  • Pain and Suffering: Damages for emotional, physical, mental, and financial issues.
  • Loss of Consortium: When a patient has medical problems, it can lead to lack of intimacy between relationships. Spouses of patients may be entitled to film this kind of claim.

Bladder Cancer

The British Medical Journal published a study on pioglitazone back in May 2012. It was found that people who take the drug for a lengthy period of time have an 83 percent increased risk of obtaining bladder cancer.

Prior to 2012, a number of studies, which includes Takeda Pharmaceuticals’ own preclinical trials, have already shown connections between the use of the drug to bladder problems. In fact, male rats were also found to have bladder tumors after obtaining the drug.

The FDA states that from two supplementary three-year studies – a liver safety study and the PROactive study – researchers found an increased occurrence of bladder cancer in patients who took the drug, as compared to patients who received other drugs.

This prompted the FDA to require Takeda Pharmaceuticals to conduct a 10-year study on the drug’s association with bladder cancer. The study, conducted by Kaiser Permanente Northern California, started in 2002.

Symptoms of bladder cancer include: bloody urine, pain during urination, increased urges to urinate, and unusual back pain.

Congestive Heart Failure

The Actos drug label also includes a black-box warning for congestive heart failure. The drug is classified under thiazolidinedione (TZD), which is known to cause or even degenerate the condition.

Patients with a history of heart failure need to be monitored regularly when under the medication of the drug. Furthermore, pioglitazone is not recommended for individuals who are suffering from symptomatic heart failure, or heart failure in stages III or IV.

Some symptoms of congestive heart failure:

  • Excessive and /or rapid weight gain
  • Difficulty in breathing (dyspnea)
  • Fluid retention and swelling (edema)

Chronic Kidney Disease

A study conducted by Taiwan’s Kaohsiung Medical University was published in the Public Library of Science. According to the study, researchers found that pioglitazone heightened the risk of chronic kidney disease.

The study observed 35,000 participants with diabetes between 2005 and 2009. It was found that people taking the Type 2 diabetes drug were more likely to garner kidney disease four-fold than patients who did not take the Takeda drug.

Lactic Acidosis and Bone Fractures

Women who take pioglitazone are more at risk of suffering from bone fractures, most particularly in the hands, feet, ankles, and lower legs. In addition, Actos also carries a warning in its label, noting the risk of obtaining lactic acidosis.

Lactic acidosis can be fatal in patients (if untreated, it is fatal 50 percent of the time), it is important to take note of the following symptoms: any diabetes problems (macular edema or diabetic ketoacidosis), heart problems or serious heart failure, edema, Type 1 diabetes, liver disease, fever, trauma, fragile bones, active bladder cancer or a history of bladder cancer, and pregnancy or plans to be pregnant.

Kidney disease, liver disease, ketoacidosis and diabetes can also result in an increase in lactation, which is one of the most severe side effects linked to the drug.

Patients with the following conditions can increase the risk of developing lactic acidosis:

  • Kidney insufficiency
  • Congestive heart failure
  • Liver dysfunction
  • High alcohol consumption
  • Surgery

These symptoms may indicate the presence of lactic acidosis:

  • Nausea
  • Rapid breathing
  • Stomach pain
  • Tiredness
  • Irregular heartbeats
  • Anemia
  • Severe low blood pressure

Liver Failure

There have been several reports of both fatal and non-fatal cases of liver failure among individuals who take pioglitazone. Based on the drug insert accompanied with the medication, there is no evidence that suggests the drug to not cause liver problems.

It is recommended that doctors test the liver of patients before actually prescribing pioglitazone. They should also be monitored regularly for indicators of liver damage, including fatigue, anorexia, upper abdominal discomfort, dark-colored urine, and jaundice.

FDA Recalls, Reports and Warnings

In 2007, the FDA required the drug manufacturers to add black-box warnings to both Actos and its predecessor Avandia, after studies presented that the medications heightened the risk of congestive heart failure.

The U.S. FDA issued a Drug Safety Communication back in June 2011, stating that the drug could increase the risk of developing bladder cancer by 40 percent.

Actos litigations first started in 2011 after a report from the French Medicines Agency came to light noting that the drug heightened the risk of bladder cancer in patients by 40 percent. This led to French and German health officials banning the drug the same year. Eventually, India also banned the drug.

Although the lawsuits regarding pioglitazone are rising, Takeda Pharmaceuticals have never issued a recall in the United States – while other countries banned the drug.

It was in August 2011 – the same year its manufacturer lost patent rights to the drug – when the FDA required Takeda Pharmaceuticals to update the drug’s Warnings and Precautions portion of the label to include a notice on the connection between long-term use (for more than a year) and increased risk of bladder cancer.

The drug manufacturer released the results of the 10-year study in 2014. Not all the details were released, but it was stated: “The 10-year final analysis did not show any statistically significant findings of the increased risk of bladder cancer with long term use of pioglitazone.”

However, many other studies – including the drug maker’s five-year interim study – presented an increased risk. Individuals who took the drug for over a year had two times the risk as compared to patients who did not use the drug.

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