Actos Side Effects
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; from mild (headaches and sore throats) to severe (congestive heart failure).
The clinical trials also showed that Actos is linked to an increased risk of bladder cancer. Because of this, a 10-year observational study of the drug was started with 193,099 diabetes patients. Patients involved in this study had been diagnosed with diabetes and were older than 40.
The study showed that there is a strong link between Actos and bladder cancer after extended use of the drug. The drug has been pulled off the market in France and Germany. The FDA is reviewing the safety concerns. Any side effects should be reported to your doctor.
Takeda has taken a wait-and-see attitude in response to increased reports of severe side effects leading to severe 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 related to Actos and would like to learn more about your legal rights call 1-800-439-8180 or fill out the form below.
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 determined that side effects that happen in 1 percent or more of patients taking a medicine are considered to be caused by the medicine.
Some side effects are severe enough that they require immediate medical attention, while others do not. Some might be related to preexisting health conditions like age, weight, gender and overall health. In addition, ethnicity and race may play a role in side effects.
Based on clinical trials, there are several common side effects experienced by many people:
- Upper respiratory infection (similar to the common cold)
- Headache
- Sinus infection or sinus irritation
- Shortness of breath
- Chest pains
- General ill feeling
- Muscle pain
- Tooth pain and problems
- Sore throat
- Swelling and water weight gain
- Allergic reactions such as skin rashes, hives, itching or swelling of the face, lips or tongue
- Breathing problems
- Fever, chills
- Unusual fatigue
- Slow or sudden weight gain
- Low blood sugar or hypoglycemia
Other side effects include diarrhea, urinary tract infection, dizziness and limb pain. Women who are pregnant or planning to become pregnant should not use this drug. It is unclear if it will harm your unborn baby.
Drug Insert Warnings
You should be aware of all potential side effects and drug interactions related to taking this drug. 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 drugs’ effects at various concentrations.
Also included in the drug insert are the contraindications, which explains when the drug should not be used. The insert also includes other warnings, precautions, adverse reactions, drug-abuse potentials and over-dosage results. There are no completed studies on the the safety of Actos when taken by children under age 18 and women who are pregnant or breastfeeding.
You need to be aware of these possible complications:
- Taken in combination with insulin there may be an increased risk for hypoglycemia. Symptoms include being lightheaded, being dizzy and shaking.
- Patients with edema (swelling) must use caution. Actos has been known to bring edema on or worsen preexisting edema. This fluid retention could lead to congestive heart failure.
- Cases of congestive heart failure have been reported in patients with and without previously diagnosed heart disease.
- It has been related to weight gain, possibly due to a combination of fat accumulation and fluid retention.
- It may cause ovulation in some premenopausal, anovulatory women. There is an increased risk of pregnancy while taking Actos.
- It is known to cause decreases in hemoglobin and hematocrit. These changes could be related to increased plasma volume. It can also cause low red blood cell count (anemia).
- Talk to your doctor if you are going to have an X-ray procedure using injectable dye and are taking Actoplus. Some injectable dyes interact with it.
- Actos inactive ingredients are lactose monohydrate, hydroxypropylcellulose, carboxymethylcellulose calcium, and magnesium stearate. Do not take this drug if you are allergic to any of the ingredients.
- Actos may cause liver damage. Talk to your doctor if you have unexplained nausea, vomiting, stomach pain, unusual tiredness, loss of appetite, dark urine or yellowing of the eyes or skin. These can be a symptom of liver damage. Those with active liver disease should not take this drug.
- Patients currently taking gemfibrozil or rifampin in combination with Actos should know that a significant drug interaction may occur.
- Those with existing bladder cancer should not take Actos.
Severe Side Effects Associated With Actos
Clinical studies show that Actos patients can develop severe side effects. One of them is a higher risk of developing dangerous medical conditions; such as, bladder cancer, congestive heart failure, bone fractures and lactic acidosis.
This drug can also worsen pre-existing medical conditions. Patients with pre-existing congestive heart failure (NYHA Class I or II) are recommended to start taking 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.
Severe Actos side effects bring an increased risk of extended illness or death:
Bladder Cancer
Recent studies have shown a link between Actos and bladder cancer. 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 showed an increased risk of bladder cancer to 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. 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 of bladder cancer: 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 U.S. Food and Drug Administration (FDA). The drug is linked to an increase in heart failure in both patients with and without pre-existing heart problems. Actos and its counterpart GlaxoSmithKline PLC’s Avandia, long have 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 and is different from a heart attack, the Dow Jones newswire reported. Heart enlargement was observed in mice, monkeys and dogs being treated orally with pioglitazone.
Macular Edema
Diabetic eye disease with swelling in the back of the eye, called macular edema, has been reported in diabetic 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 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.
