Frequently Asked Questions
What is Actos®? Who makes it?
Actos® (Piogliatazone) is manufactured by Takeda Pharmaceuticals for treatment of Type II Diabetes, and has been on the market since 1999. We believe that Takeda's failure to adequately warn consumers of the increased risk of bladder cancer, and failure to warn about other potential medical problems, makes them potentially liable for your injuries and damages. Some medical experts believe that Actos is dangerous enough that the FDA should issue a full recall of the medication, or that new and updated warnings should be included. Both France and Germany have already pulled the drug from their markets. The largest concentration of Actos users to develop bladder cancer had been taking the medication between 2-5 years, but the next largest group had only been taking it for 1-6 months. No matter how short of a time you have been taking Actos, if you have side effects, you should go see your doctor immediately.
What are the side effects?
Possible Actos® Side Effects Can Include:
- Blood in urine
- Pain during urination
- Frequent urination
- Feeling of a need to urinate without results
- Bladder Cancer
- Heart Attack
- Heart Failure
- Liver Damage
- Death
What about long-term use?
FDA recently issued a drug safety communication warning patients and health professionals that use of pioglitazone (Actos–Takeda) for more than 1 year may be associated with an increased risk of bladder cancer. Patients who were on pioglitazone therapy for more than 12 months had a 40% increased risk of bladder cancer compared with patients who had never used the drug.
What kind of warning has the FDA issued on Actos®?
Amidst an intense debate over the safety of Type-2 diabetes drugs, the FDA has asked the makers of Actos® to issue a black box warning. A black box warning is the strongest FDA-requested label change that can be added to a drug.
The FDA is currently analyzing Actos® clinical data to determine whether further regulatory action, such as an Actos® recall, is warranted.
Should I consult a doctor?
The partners of Aylstock, Witkin, Kreis & Overholtz does not intend, by this web site or otherwise, to dissuade anyone from taking medication without their doctors' approval. Please consult your doctor, not your lawyer, on matters relating to your health. It could be dangerous to stop taking medicines, especially abruptly. Patients should talk to their physicians to decide whether the benefits and risks of taking Actos® make it the right choice for them.
Aylstock, Witkin, Kreis & Overholtz, PLLC
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