ACTOS Resources for Diabetics, Patients and Concerned Family Members
See our ACTOS Risks page.
FDA (Food and Drug Administration) Action
Faced with mounting evidence of bladder cancer risks for ACTOS users, the FDA has mandated that a clear warning about these risks be added to the drug’s warning label and to the Patient Medication Guide. To healthcare professionals, the FDA recommends:
- Not using ACTOS in patients with active bladder cancer; and
- Using ACTOS “with caution” in patients with a history of bladder cancer, after weighing the benefits of blood sugar control with ACTOS against the unknown risk of cancer.
Patients taking ACTOS are warned not to take the drug if they are being treated for bladder cancer, and to tell their doctor immediately if symptoms of bladder cancer should appear, such as blood or red color in urine, urgent need to urinate or pain while urinating, or pain in the back or lower abdomen.
Takeda, a Japanese pharmaceutical company that manufactures and markets ACTOS, responded to the FDA’s action with a combination of denial and assurances that it would monitor follow-up studies. The drug company focused on the “good news” of the interim study of Kaiser Permanente patients, that short-term use of ACTOS was not associated with increased bladder cancer risk, which is of little comfort to patients and their doctors.
Takeda stands firm that the risk associated with long-term use was only “weakly associated with increased risk” of bladder cancer. This is no surprise, given that in 2010, ACTOS sales earned Takeda more than $4.8 billion.
ACTOS – Important Patient Information
If you or a family member has Type 2 diabetes, whether you are taking ACTOS for the first time or a regular user, here are some recommendations from the National Institutes of Health:
- Tell your doctor if you have a condition that may make you especially vulnerable to adverse effects such as bladder cancer, macular edema, liver disease or a heart condition.
- Be honest about all of the medications you take regularly, both prescription and over-the-counter drugs and supplements. Some well-known drugs can interact negatively with ACTOS.
- If you are taking oral contraceptives, be sure your doctor knows what kind.
- Tell your doctor if you are pregnant or plan to become pregnant. ACTOS is designated Pregnancy Category C by the FDA, meaning that there is not clear evidence about this drug’s effect or lack of any effect on an unborn baby.
- Do not breastfeed while taking ACTOS; it is not known whether ACTOS will harm a nursing infant.
- If you are a woman who has not gone through menopause, be aware that ACTOS could increase your chance of becoming pregnant.
- Alert your surgeon or dentist that you are taking ACTOS if you are having medical or dental surgery.
- Ask your doctor what to do in physical or emotional situations that could affect blood sugar and change the amount of ACTOS you need.
The bottom line for Type 2 diabetes patients taking ACTOS is the same as for patients taking any medication that has health benefits paired with serious risks: Learn more, and talk with your doctor.