Skip to content


South Carolina Actos Injury Drug Lawyer – Detailed Information About the Potentially Grave Risks Associated With This Diabetes Medication

Actos is a medication used to treat Type 2 diabetes patients to regulate blood sugar levels, but our Actos attorneys have been reviewing recent reports about serious side effects. Individuals taking this medication should know that the FDA issued a warning that Actos (pioglitazone) is associated with an increased risk of bladder cancer. A person should not stop taking any prescribed medication without a doctor’s approval.

However, if you were prescribed Actos for Type 2 diabetes, you should review alternative treatments with your doctor or seek a second opinion immediately. Patients who develop bladder cancer or other diseases because of taking Actos may be entitled to financial compensation. Our South Carolina lawyers provide options and representation to patients harmed by dangerous drugs.

Click on the following links to learn more about Actos problems and legal issues:

Actos Warning Issued by FDA

The FDA issued a warning for Actos on June 15, 2011, that taking the drug for over one year will increase the risk of bladder cancer. This was the conclusion of a five-year study that led to France and Germany outlawing the drug for new patients. The U.S. FDA recommends that:

  • Individuals with active bladder cancer should not take Actos (pioglitazone)
  • Individuals with a history of bladder cancer should not take the drug without serious consideration of its risks and supposed benefits

In 2007, the FDA issued a black box warning that Actos, Actoplus Met and Duetact may cause or exacerbate heart failure. A black box warning is the FDA’s strongest warning, and the Actos labels were updated to state the increased risks of causing or worsening heart conditions.

The FDA based its findings on adverse events reports regarding various Actos side effects that included warning signs of heart failure, such as significant weight gain, edema, shortness of breath and death. The FDA’s actions requiring the black box warning were insufficient to protect many patients who experienced heart failure and died due to Actos.

<Back to Top>

Actos Brand Names and Generics

Japanese corporation Takeda Pharmaceuticals manufactures the drug Actos (pioglitazone) and markets it under a few different names. Recently, generic versions of the drug were released into the U.S. market, despite FDA Actos warnings that the drug leads to increased risks of diseases and injuries. These manufacturers make billions of dollars in profits off selling the type 2 diabetes drug Actos. Our drug injury attorneys may file lawsuits against negligent manufacturers and distributors of dangerous pharmaceutical drugs on behalf of patients seriously injured by taking those dangerous drugs.

The following are Actos brand names manufactured by Takeda Pharmaceuticals:

  • Actos

When Actos is combined with the drug metformin, it is sold under the brand names:

  • ACTOplus met
  • ACTOplus met XR
  • Competact

When Actos is sold with the drug glimepiride, it is known as:

  • Duetact

Generic versions of Actos were first released onto the market in August 2012. There is no reason to believe that these generic versions will not have the same serious and potentially deadly Actos side effects, including bladder cancer, congestive heart disease, liver disease and bone fractures.

The generic versions of Actos are called:

  • Pioglitazone
  • Pioglitazone hydrochloride

The following manufacturers are now making and marketing generic versions of the drug Actos (pioglitazone):

  • Watson Pharmaceuticals
  • Mylan Pharmaceuticals
  • Ranbaxy Laboratories
  • Teva Pharmaceutical Industries

Generic Actos sales are expected to bring in huge profits from U.S. patients. The total sales from various Actos brand names and generics were estimated to be approximately $2.7 billion in the 12-month period ending in August 2012. Ranbaxy Laboratories is expected to profit over $200 million in sales during the exclusivity period alone. Generic versions of type 2 diabetes drug Actos are expected to bring in over $8 billion in sales to manufacturers through 2020.

<Back to Top>

Actos Diseases

After a five-year study, the drug Actos was shown to cause an increased risk of bladder cancer for patients taking the medication for over one year. After a different study performed in France also evidenced an increased risk of bladder cancer, both France and Germany issued an Actos recall in their countries. The FDA issued a safety warning that Actos use for more than one year may be associated with an increased risk of bladder cancer. The FDA warns:

  • Individuals with active bladder cancer should not take Actos
  • Individuals with a history of bladder cancer should not take the drug without serious consideration of its risks and supposed benefits

Even patients with no history of bladder cancer may develop deadly Actos side effects. Symptoms of bladder cancer include:

  • Blood in urine
  • Urinary urgency
  • Pain during urination
  • Back and abdominal pain

In 2007, the FDA required black box warning, its strongest form of warning, that Actos may cause or worsen heart failure in some patients, potentially resulting in death. Anyone with the following symptoms of heart failure must seek medical attention immediately:

  • Unusually fast weight gain
  • Fluid retention (swelling)
  • Shortness of breath
  • Unusual tiredness.

In addition to bladder cancer and heart failure, ingredients in ACTOplus met and ACTOplus met XR, causes a rare but serious condition called lactic acidosis (a buildup of an acid in the blood). The risk of lactic acidosis is higher for people who have liver disease and it can worsen the condition and cause death. Get to an emergency room immediately if you experience the following Actos side effects:

  • Unexplained weakness or tiredness,
  • Muscle pain, stomach pain,
  • Nausea or vomiting,
  • Trouble breathing,
  • Dizziness or lightheadedness, or
  • Slow or irregular heartbeat occurs.

<Back to Top>

Actos Side Effects

An increased risk of bladder cancer is linked to Actos. Other potentially grave side effects include heart failure or congestive heart disease and liver problems.

An ingredient in Actos has been found to cause lactic acidosis. This risk is high for patients who have kidney and liver problems, are heavy alcohol drinkers, are dehydrated, have surgery, experience a heart attack, or have a severe infection or stroke while taking the drug. Lactic acidosis can cause death, and anyone experiencing the following symptoms must get to an emergency room at once:

  • Weakness or fatigue
  • Muscle and stomach pain
  • Nausea and vomiting
  • Difficulty breathing
  • Dizziness and lightheadedness
  • Slow or irregular heartbeat

Additional Actos Side Effects Harming Patients

  • Broken Bones and Fractures. These most often occur in the hand, upper arm and foot in women.
  • Macular Edema. This is an eye disease causing swelling in the back of the eye.

<Back to Top>

Actos Manufacturer Liability

Many pharmaceutical corporations are aware of their drugs’ dangers and safety risks, but fail to inform the public, purposefully hide the information or pay researchers to write articles touting the safety and usefulness of their product. Although the FDA monitors drugs on the market, the agency typically issues warnings or recalls after many patients have died or have suffered severe injuries or diseases.

Pharmaceutical litigation, also known as drug injury lawsuits, holds corporations responsible to the persons injured by a defective product based on the legal theory of negligence. It is unnecessary for the FDA to issue an Actos recall for injured patients to prove negligence in a court of law. The elements of legal negligence are:

  • The corporation has a duty to manufacture and market safe drugs to patients;
  • The corporation breached that duty by manufacturing dangerous drugs or marketing products in a negligent manner; and
  • The dangerous drug or defective medical device was the proximate cause of the patient’s injury or disease.

When a patient suffers an injury or disease as a result of taking a dangerous drug marketed as safe, the negligent manufacturer may be held responsible and ordered to financially compensate a person injured by the defective drug. The damages available in drug injury lawsuits include, but are not limited, to:

  • Medical, hospital and surgical bills
  • Lost past, present and future wages and job benefits
  • Rehabilitation and long term care
  • Necessary medical devices or adjustments to a home or car
  • Pain and suffering
  • Loss of companionship between family members

Actos litigation is ongoing in the United States. Drug injury lawyers are filing personal injury and wrongful death lawsuits against Takeda Pharmaceuticals in both state and federal courts. Although the FDA issued a black box Actos warning and a safety communication regarding the increased risks of developing Actos diseases, these actions were insufficient to protect many type 2 diabetes patients from suffering harm while taking the dangerous drug.

When injured people file separate drug injury lawsuits against the same defendants with similar claims, the federal courts may combine the suits in the pre-trial discovery phase. This is known as multidistrict litigation (MDL). The discovery phase involves disclosing evidence, and combining the claims for discovery saves time and money. In multidistrict litigation, after the discovery phase is completed, each lawsuit will proceed separately.

Currently, In Re: Actos (pioglitazone) Products Liability Litigation (M DL No. 6:11-md-2299) is multidistrict litigation that has consolidated all the federal cases into the U.S. District Court for the Western District of Louisiana (Lafayette). Several thousand plaintiffs are part of this Actos litigation; additional plaintiffs from around the country continue to join the suit.

Besides the option of joining federal multidistrict litigation, some injured individuals may benefit from filing drug injury lawsuits in state courts. Some states have consolidated Actos litigation as mass tort litigation, similar to MDL. Whether a state or federal lawsuit would be in a client’s best interest will depend on the specific circumstances of the case and the state in which the injured individual resides.

<Back to Top>

Actos Lawyers Filing Drug Lawsuits on Behalf of Injured Clients

Although a full Actos recall has yet to be issued, if you have experienced any of the listed side effects and have suffered an injury while taking Actos, you may have a legal case against the pharmaceutical manufacturer. Contact our Actos attorneys to have all your questions answered about Actos lawsuits and holding negligent manufacturers accountable to the public.