Article: Actos Consumer Information

What is Actos used for?

Actos, in addition to diet and exercise, improves blood sugar control in patients with type 2 diabetes (non-insulin dependent diabetes). Actos can be used alone or in combination with a sulfonylurea, metformin, or insulin when diet, exercise, and one of these agents or diet, exercise, plus Actos alone are not are not enough to control blood sugar.

Who should not take Actos?

· Do not take Actos for Type 1 diabetes (juvenile diabetes) or diabetic ketoacidosis.

· If you have heart failure, fluid retention or active liver disease your health care provider will evaluate you to decide if Actos is right for you.

Reports of Patients’ Experiences Since Actos Became Available:

There have been reports of inflammation of the liver (hepatitis) and elevated liver enzymes. It has not been determined whether these events are directly related to Actos. It is recommended that patients taking Actos have their liver enzymes monitored periodically.

General Precautions with Actos:

· Actos is in the same class of drugs as Rezulin, which has been associated with rare but serious liver injury, including liver failure leading to transplant or death. Because the liver safety profile of Actos is not fully determined yet, your doctor will do blood tests that evaluate your liver before starting you on Actos. These blood tests should be repeated every two months for the first year, then regularly after that.

· Call your health care provider right away if you develop nausea, vomiting, stomach pain, a feeling of tiredness or having no energy, loss of appetite, dark urine, or jaundice (yellow coloring of eyes and skin). These may be the symptoms of liver problems.

· Patients who experience an unusually rapid increase in weight or retain fluid (edema) or who develop shortness of breath or other symptoms of heart failure while on Actos should immediately report these symptoms to their health care provider.

· When taking Actos with insulin or certain other oral diabetes medicines, there is a risk of your blood sugar becoming dangerously low. Ask your health care provider about symptoms of low blood sugar, conditions that make low blood sugar more likely, and what to do if you get it. Make sure to explain to family members.

· If you are a woman who has not reached menopause but have not had menstrual periods; you may become pregnant unless you use an effective method of birth control. Actos, like other drugs in this class, may cause insulin resistant women to start ovulating again.

· Women should tell their doctor if they notice any changes in their monthly menstrual cycle.

· During periods of stress on the body, such as fever, trauma, infection, or surgery, your medication requirements may change; contact your health care provider promptly.

What should I tell my doctor or health care provider?

Women taking oral birth control pills should talk to their health care provider when taking Actos, because the effectiveness of oral birth control pills can be reduced.

Tell your health care provider if you are trying to become pregnant, are already pregnant, or are breast-feeding.

Because certain other medications may interact with Actos, review all medications that you are taking with your health care provider, including those that you take without a prescription.

What are some possible side effects of Actos?

(This list is not a complete list of side effects reported with Actos. Your health care provider can discuss with you a more complete list of side effects.)

· cough or cold

· headache

· inflammation of the sinuses or throat

· muscle pain

· swelling or fluid retention

For more detailed information about Actos, ask your health care provider.

Posted: 3/28/00
Revised: 3/14/01, 05/26/04

Basic Information

Brand Name: Actos®
Active Ingredient: pioglitazone
Strength(s): 15 mg, 30 mg, and 45 mg
Dosage Form(s): Tablets
Company Name: Takeda Chemical Industries, Ltd.
Availability: Prescription only
*Date Approved by the FDA: July 15, 1999
*Approval by FDA does not mean that the drug is available for consumers at this time.

Source: U.S. Food and Drug Administration
Cache Date: February 24, 2005