Actos Side Effects – Common and Severe

Because Actos (pioglitazone) can cause serious side effects, Consumer Reports suggests that consumers avoid the diabetes drug except as a “last resort.”

“We say skip Actos as both generic and brand-name medication, unless other options have not worked,” the well-respected product-review publication stated in August 2012, the same month generic versions of Actos hit the market.

During the Actos clinical trials, nearly 10,000 type 2 diabetes patients were treated with the drug. The trials showed that patients can suffer a wide range of side effects that range from mild (headaches and sore throats) to severe (congestive heart failure).

In numerous postmarket studies, Actos also has been linked to bladder cancer. The drug has been pulled off the market in France and Germany. The Food and Drug Administration (FDA) is reviewing the safety concerns.

Takeda has taken a wait-and-see attitude in response to increased reports of severe Actos side effects leading to life-threatening medical conditions. This has prompted many to file lawsuits seeking compensation to cover medical expenses as well as pain and suffering. If you have experienced severe side effects of Actos and would like to learn more about your legal rights call (800) 452-0949 or fill out the form on this page.

Common Actos Side Effects

There are several well-known common Actos side effects. These side effects can happen when you begin taking the drug, increase your dosage or stop the medicine. Medical researchers have determined that common Actos side effects occur in 1 percent or more of patients taking the type 2 diabetes drug.

Some side effects of Actos are severe enough that they require immediate medical attention, while others do not. Some might be related to things like age, weight, gender and overall health. In addition, ethnicity and race may play a role in side effects.

Other side effects of Actos include diarrhea, urinary tract infection, dizziness and limb pain. Women who are pregnant or planning to become pregnant should not use this drug. No studies have been done on whether taking Actos during pregnancy has any adverse effects.

Severe and Life-Threatening Side Effects of Actos

Although less common, clinical studies have shown that patients can develop severe and life-threatening Actos side effects, such as bladder cancer, congestive heart failure, bone fractures and lactic acidosis.

Actos side effects can also worsen pre-existing medical conditions. Patients with pre-existing congestive heart failure (NYHA Class I or II) should start Actos at lower dosages. It is recommended that heart patients be monitored closely when taking Actos for symptoms of congestive heart failure, including weight gain and edema. Bladder cancer is another life-threatening Actos side effect, and users with a history of cancer, bladder tumors or bladder problems in general should only use the drug as a last resort medication.

Bladder Cancer

Bladder cancer is one of the most dangerous side effects of Actos. During clinical studies, drug-induced tumors were discovered in the urinary bladders of male and female rats after a two-year carcinogenic study. The first five years of a 10-year follow-up study in humans showed an increased risk of bladder cancer in those patients who take pioglitazone for an extended time. The FDA said patients taking Actos for more than one year have a 40 percent increased risk for bladder cancer. A study published in May 2012 in the British Medical Journal puts the increased risk at 83 percent.

You should not take Actos if you are being treated for bladder cancer. Tell your doctor right away if you have any of the following symptoms: blood or a red color in your urine, an increased need to urinate or pain while you urinate.

Heart Failure

Actos carries a black-box warning, the toughest warning given by the FDA, for its heart risks. The drug is linked to an increase in heart failure in patients with or without pre-existing heart problems. Actos has long been shown to increase the risk of heart failure, a condition that develops over time and is characterized by the heart’s inability to properly pump blood; it is different from a heart attack. Two Actos side effects, severe weight gain and water retention (edema), are both known to contribute to heart problems.

Macular Edema

Eye disease with swelling in the back of the eye, called macular edema, has been reported in patients taking pioglitazone. Some patients experience blurred vision or decreased visual acuity. It is recommended that patients with diabetes have regular eye exams by an ophthalmologist. Actos patients should report any acute vision problems to a physician immediately.

Bone Fractures

A randomized trial in patients with type 2 diabetes showed an increased incidence of bone fractures in female patients taking pioglitazone. During a follow-up, the incidence of bone fractures was 5.1 percent for pioglitazone users versus 2.5 percent for placebo users. Most of the fractures were seen in female patients in the hands, upper arms and feet.

Hepatic Failure

There have been reports of fatal and non-fatal hepatic failure (liver failure) in Actos patients. Periodic monitoring of liver enzymes is recommended because of reports of hepatitis and hepatic enzyme elevations. If jaundice (yellowing of the eyes and skin) occurs, Actos should be stopped. Jaundice is a sign of liver problems.

Kidney Disease

A new study suggests that Actos is also harmful to the kidneys. The large study, conducted at the Kaohsiung Medical University in Taiwan, involved 35,000 people with diabetes. It was published in the January 2014 issue of PLoS One and revealed that over 8 percent of study participants using Actos developed chronic kidney disease. In fact, the disease developed even in people who were prescribed relatively low doses of the drug and used it for less than a year.

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Drug Insert Warnings

You should be aware of all of the potential side effects of Actos and its interactions with other drugs. Detailed Actos warnings about interactions and side effects are included in the documentation provided in the prescription box. It includes clinical pharmacology, which explains how the drug works in the body, how it is absorbed in the body and the drug’s effects at various concentrations.

Also included in the drug insert are the contraindications, which explain when the drug should not be used. The insert also includes other warnings, precautions, adverse reactions, drug-abuse potentials and overdosage results. There are no completed studies on the the safety of Actos when taken by children under age 18 or women who are pregnant or breastfeeding.