Actos (pioglitazone), the most popular diabetes drug of all time, comes with a long list of contraindications — which warn against prescribing the drug to patients suffering from an existing condition that will be worsened by the drug.
Each drug that is approved by the Food and Drug Administration (FDA) comes with Complete Prescribing Information for doctors and a Medication Guide for pharmacies to pass along to patients with their prescriptions. These documents include contraindication information, as well as an overdose description. This information may also be included in the medicine packaging.
Because Actos is a relatively new drug and studies of long-term use are continuing, the contraindication list keeps growing. In 2007, the FDA added a black-box warning to Actos, detailing its heart failure risk. In 2011, bladder cancer and liver problems were added to the warnings list. Actos also should avoided by anyone with liver problems, type 1 diabetes or eye disease, or who is pregnant or planning to become pregnant.
Thousands of lawsuits have been filed by patients who say they were not sufficiently warned about the risks of taking Actos. If you or someone you know has suffered after taking Actos, you may have a legal case. Call one of our Patient Advocates at (800) 452-0949 to discuss your legal options.
Contraindications for Actos
The only official contraindication in the Actos Prescribing Information says Actos should not be used by patients with Class III or IV heart failure. These are classifications from the New York Heart Association. Class III means that a patient has marked limitation of physical ability because of their heart failure. Class IV means that a patient is not able to carry out any physical activity comfortably.
Under the Warnings and Precautions, the following conditions are listed:
- Congestive heart failure
- Hepatic (liver) effects
- Bladder cancer
- Macular edema
- Macrovascular outcomes
Under bladder cancer, the Prescribing Information reads:
“Preclinical and clinical trial data, and results from an observational study suggest an increased risk of bladder cancer in pioglitazone users. The observational data further suggest that the risk increases with duration of use. Do not use in patients with active bladder cancer. Use caution when using in patients with a prior history of bladder cancer.”
Studies show that Actos increases the risk of developing bladder cancer by 80 percent or more. Patients are encouraged to talk with their doctor about this risk and other risks associated with Actos use. Actos should be discontinued only if a doctor makes that decision.
In addition, the Actos Medication Guide tells patients to talk to their doctor about the following conditions before taking the drug:
- Type 1 diabetes
- Diabetic ketoacidosis
- Diabetic eye disease (macular edema)
- Liver problems
- Pregnant or plan to become pregnant
- Premenopausal woman who does not have periods regularly
- Breast-feeding or plan to breast-feed
Actos Dosage and Overdose
Actos is taken one time each day. Doctors can decide what time of day is best. It does not have to be taken with food. A missed dose should be taken as soon as the patient remembers, but two pills should not be taken in the same day.
Actos comes in 15 mg, 30mg and 45mg doses. It also comes in combination form, and each medication comes in different doses.
The combination drugs are:
- ACTOplus met
- ACTOplus met XR
- duet act
Patients should discuss each medication with their doctor to learn about contraindications specific to the pill they are taking.
When a drug is taken in higher amounts than prescribed, it is called an overdose. An overdose can harm or kill a patient.
The prescribing information for Actos mentions one overdose case during controlled clinical trials. The patient took 120 mg per day for four days, then 180 mg per day for seven days. The patient did not show any clinical symptoms.
General symptoms of overdose include:
- Visual disorder
- Internal bleeding
- Breathing difficulty
If an overdose is suspected, 911 should be called immediately, and the first person on the scene should begin cardiopulmonary resuscitation (CPR) if the person is not breathing or their heart has stopped.
Poison control should be called after 911 at (800) 222-1222. The drug the person took should be given to the emergency medical personnel when they arrive. At the hospital, the patient’s stomach may be pumped, and charcoal may be given to absorb the drug.