Actos (pioglitazone) can cause serious side effects, including bladder cancer and heart failure. Patients who suffered may have legal options.
What are 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. There are several common Actos side effects:
- Upper respiratory infection (similar to the common cold)
- Sinus infection or sinus irritation
- General ill feeling
- Muscle pain
- Tooth pain and problems
- Sore throat
- Allergic reactions such as skin rashes, hives, itching or swelling of the face, lips or tongue
- Fever, chills
- Unusual fatigue
- Low blood sugar or hypoglycemia
Severe and Life-Threatening Side Effects of ActosAlthough 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 CancerBladder 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 FailureActos 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 EdemaEye 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 FracturesA 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. Women who take Actos are two to three times more likely to break bones than women who take other diabetes medicines. In 2008, Swiss researchers released their findings from analyzing 12 years of data from diabetes patients in the United Kingdom. Their study showed that patients taking TZDs had two or three times the risk of fractures than patients taking other diabetes medicines. Another study, conducted by Henry Ford Hospital in Detroit, found that female TZD users had a 57 percent increased risk of broken bones compared with women who did not take Actos.
Hepatic FailureThere 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 DiseaseA 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.
Drug Insert WarningsYou 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.
|Side effects of Actos when taken with other drugs or in certain situations|
|Taken with Existing Condition||Taken with Other Drugs|
|Actos + Heart Disease = heart failure||Actos + Insulin = hypoglycemia|
|Actos + Bladder Cancer = worsening of bladder cancer||Actos + Gemfibrozil = drug reaction|
|Actos + Liver Damage = worsening of liver damage||Actos + Rifampin = drug reaction|
|Actos + Edema = heart failure|
Do Not take if Allergic to the Following Drugs
- Lactose Monohydrate
- Magnesium Stearate