You may have already heard about the serious health risks of the diabetes medication Actos. In order to help patients understand when and how this drug can affect them, our firm has collected the most important facts and prescribing information here, as well as which patients are advised against taking Actos to treat high blood sugar.
Certain Patients Are Warned Against Taking Actos® for Diabetes
Actos, also known by its generic name pioglitazone, is an oral tablet prescribed to lower blood sugar levels in patients with type 2 diabetes mellitus. Both men and women over the age of 18 can be prescribed Actos, but children are currently prohibited from taking the medication.
Patients should avoid drinking alcohol when taking Actos, as it can interfere with blood sugar levels and make treating diabetes more difficult. In addition, patients should not be prescribed Actos if they:
- Are in a state of diabetic ketoacidosis
- Suffering from type 1 diabetes
- Are allergic to pioglitazone
- Have been diagnosed with heart failure or severe heart disease
- Have a history of bladder cancer or have been recently been diagnosed with bladder cancer
- Are prone to or are suffering from fluid retention (edema)
- Have a history of heart attack or stroke
- Have been diagnosed with liver disease
- Are taking certain antibiotics (such as rifampin)
- Are taking insulin or oral diabetes medications such as acetohexamide, glimepiride, or glipizide
The FDA has adopted a black-box warning for Actos about the risk of heart problems, and has issued a number of warnings about other known risks of taking Actos, including bladder cancer, edema, congestive heart failure, and kidney problems. The agency has said that patients taking pioglitazone for more than one year have a significantly increased risk for bladder cancer, and at least one study has shown the risks of bladder cancer to increase in patients within the first five years of taking Actos.
Patients may begin to show symptoms of Actos side effects within a few weeks of taking the drug, for an undetermined about of time after stopping the drug, or any time the dosage is increased. Patient should seek emergency medical assistance if they suffer signs of an allergic reaction (such as to hives, difficulty breathing, or swelling of the lips and mouth), and should be on the lookout for signs of serious medical conditions (such as swelling in the feet and legs, feeling short of breath, or presence of pink or red urine).
Actos Risks for Women
Women may be at higher risk of certain complications of Actos, especially if they are pregnant or are nursing. Some research suggest that women are more likely to suffer bone fractures in their hands, feet, and upper arms than men who take similar doses of Actos. There have been no studies that show the effects pioglitazone can have on an unborn baby, so women are advised not to take Actos while pregnant. Similarly, there is no conclusive evidence of the effects of pioglitazone when passed to an infant through breast milk, so mothers should avoid breastfeeding while taking this medicine.
Some women have experienced a restarting of their menstrual periods shortly after they began taking Actos, even those whose periods had previously ceased for a year or longer. As a restarting of the menstrual cycle can lead to unintended pregnancy, women should talk to their doctors about the possibility of using birth control while taking Actos.