Actos, also known by its generic name pioglitazone, is a medication commonly prescribed to manage blood sugar levels in adults with type 2 diabetes. It’s often used in combination with diet and exercise to improve glycemic control and works by increasing the body’s sensitivity to insulin.
While Actos has been effective for many, it has also come under scrutiny due to serious side effects, including an increased risk of bladder cancer. These adverse effects have led to lawsuits against the manufacturers, claiming that the drug is defective and has caused significant harm to some users.
If you developed bladder cancer or suffered another serious side effect after taking the drug Actos, the knowledgeable defective drug attorneys at Nomberg Law Firm can help you explore your legal options and potentially file a lawsuit against the responsible parties.
Contact us to schedule a free consultation.
What is Actos?
Actos is a medication primarily used to treat type 2 diabetes. It was approved by the U.S. Food and Drug Administration (FDA) and put on the market in 1999. The drug works by increasing the body’s sensitivity to insulin, helping to control blood sugar levels in conjunction with diet and exercise.
Is pioglitazone linked to cancer?
Yes, the FDA has stated that the use of the type 2 diabetes medication pioglitazone, which is sold under brand names like Actos, may be associated with an increased risk of bladder cancer. In fact, the labels for pioglitazone-containing medicines already contain warnings about this potential risk.
Health care professionals are advised not to use pioglitazone in patients with active bladder cancer and to use caution when prescribing it to patients with a history of bladder cancer.
When were the dangers of Actos first identified?
Actos first came under scrutiny for its potential side effects in September 2010, when the FDA released a safety announcement to the public about a possible increased risk of bladder cancer associated with the drug. This was followed by another alert in June 2011. These alerts were based on interim results from a 10-year epidemiologic study.
In August 2011, the FDA announced that the labels of pioglitazone-containing medicines, including Actos, had been updated to include warnings about the risk of bladder cancer.
The revised labels for drugs containing pioglitazone now advise medical professionals to avoid prescribing it to patients who are currently diagnosed with bladder cancer or have a history of it.
For patients taking pioglitazone, the updated guidelines recommend reaching out to health care providers if they notice symptoms such as blood or red color in urine, a frequent urgent need to urinate, pain while urinating or pain in the back or lower abdomen, as these could be indicators of bladder cancer.
The FDA also required the manufacturer to modify and continue the 10-year study to further evaluate this risk. Over the years, additional studies have been conducted, yielding mixed results, but the concern about an elevated risk of bladder cancer has led to numerous lawsuits against the drug’s manufacturer.
What other serious side effects are associated with Actos?
Besides the risk of bladder cancer, Actos (pioglitazone) has been associated with other serious side effects that include the following:
- Congestive heart failure. Pioglitazone may exacerbate symptoms of heart failure or increase the risk of developing this condition.
- Liver problems. Some patients have reported elevated liver enzymes and even liver failure, although these instances are rare. Monitoring liver function during treatment is advised.
- Fractures. Some studies have shown an increased risk of fractures, particularly in women.
- Hypoglycemia. When used in combination with other diabetes medications, pioglitazone may increase the risk of low blood sugar levels.
- Weight gain. Actos has been linked to significant weight gain, which can be problematic for diabetics, who are often advised to maintain a stable weight.
- Vision changes. Some people may experience macular edema, a condition that can affect vision.
This list only reflects some of the more serious complications linked to the drug. If you experience these or any other symptoms while taking Actos, you should alert your health care provider so they can determine the best course of action.
Is there a lawsuit against Actos?
Yes, the manufacturer of Actos, Takeda Pharmaceuticals, has faced multiple lawsuits because of the drug’s dangerous side effects. These lawsuits generally fall under the umbrella of pharmaceutical liability, which includes categories like:
- Improper marketing. Improper marketing can lead to liability if a pharmaceutical company misrepresents the drug’s benefits, risks or appropriate uses, thereby misleading patients or health care providers.
- Failure to warn of dangerous side effects. If the company knew or should have known about the risks of serious side effects but failed to adequately warn consumers, or if the risks outweigh the drug’s benefits, the company may be legally liable.
- Defective manufacturing. Defective manufacturing can result in liability if errors occur during the production process, making the drug unsafe for consumption.
A significant portion of Actos litigation was previously consolidated into a multidistrict litigation (MDL), which is a legal procedure that consolidates multiple civil cases with common issues into a single federal court for streamlined pre-trial proceedings.
Although the MDL is no longer active, it led to significant verdicts against Takeda Pharmaceuticals, the drug’s manufacturer. The most notable was a $9 billion punitive damage award to a plaintiff in 2014, later reduced to $37 million. This case was a catalyst for a massive $2.37 billion settlement that resolved most remaining Actos lawsuits at the time.
While there are currently no class-action suits against Actos, individuals still have the option to file their own lawsuits.
Who else may be liable if I suffer a serious side effect while taking Actos?
In addition to the manufacturer of the drug, various parties could potentially be held liable, depending on the circumstances:
- Prescribing physician. If the doctor did not properly assess the patient’s medical history, failed to explain the risks and side effects, prescribed an inappropriate dosage, or failed to respond appropriately when the patient developed side effects, they might also be liable for any resulting injuries.
- Pharmacy. In some cases, a pharmacy could be liable if there was an error in filling the prescription, such as providing the wrong medication or incorrect dosage.
- Distributors and retailers. While less common, entities involved in the drug’s distribution chain could potentially be held liable under certain conditions.
- Health care facility. If the medication was administered in a health care setting like a hospital, the facility itself might also bear some liability, especially if the staff failed to properly administer the medication or monitor the patient for side effects.
Liability often involves complex legal theories, including product liability, medical malpractice and negligence, among others. Therefore, if you believe you have been injured by Actos, it’s crucial to consult with a personal injury attorney experienced in pharmaceutical or product liability law to evaluate your case.
Were you injured by the drug Actos? Nomberg Law Firm can help you get the compensation you deserve.
If you or a loved one has taken the diabetes drug Actos and suffered an injury or been diagnosed with bladder cancer, you may be entitled to significant compensation for your injuries.
The experienced personal injury attorneys at Nomberg Law Firm specialize in pharmaceutical liability cases and are committed to helping you navigate this complex legal landscape. With a strong track record of success in representing victims of defective drugs, we can guide you through each step of the legal process, from gathering evidence to representing you in court.
There are time limits for filing a claim, so the sooner you act, the better. Get started today by scheduling a free consultation.