4 Aug

2011

FDA Drug Safety Communication: Updated drug labels for pioglitazone-containing medicines

This update provides a follow-up to the Drug Safety Communication: Update to ongoing safety review of Actos (pioglitazone) and increased risk of bladder cancer issued on 6/15/2011.

[8-4-2011] The U.S. Food and Drug Administration (FDA) is informing the public that the Agency has approved updated drug labels for the pioglitazone-containing medicines to include safety information that the use of pioglitazone for more than one year may be associated with an increased risk of bladder cancer. FDA previously communicated these labeling changes to the public on June 15, 2011 (Drug Safety Communication).

The updated drug labels recommend that healthcare professionals should:

• Not use pioglitazone in patients with active bladder cancer.
• Use pioglitazone with caution in patients with a prior history of bladder cancer.

The updated drug labels recommend that patients should:

• Contact their healthcare professional if they experience any sign of blood in the urine or a red color in the urine or other symptoms such as new or worsening urinary urgency or pain on urination since starting pioglitazone, as these may be due to bladder cancer.

• Actos (pioglitazone)
• Actoplus Met (pioglitazone/metformin)
• Actoplus Met XR (pioglitazone/metformin)
• Duetact (pioglitazone/glimepiride)

Safety Announcement

[6-15-2011] The U.S. Food and Drug Administration (FDA) is informing the public that use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer. Information about this risk will be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines. The patient Medication Guide for these medicines will also be revised to include information on the risk of bladder cancer. Read Full FDA Drug Safety Communication

People whom have been injured by Actos do have legal options

If you are a patient for whom Actos was prescribed, and after having followed the instructions of your physician you have found yourself with a diagnosis of bladder cancer, you do have options. The obvious first step that you should take is seeing a medical specialist and getting your condition taken care of. But treatment of bladder cancer is expensive, and can have a dramatic effect on your lifestyle.

You may not be able to continue working or taking care of your family, and may need to hire somebody to assist you. When a drug manufacturer puts patients’ and well-being at risk, the American legal system has remedies available. These include:

• Mass Torts and Multi District Litigation: A mass tort is when a group of plaintiffs file their legal proceedings in a state court, while a multi district litigation (MDL) is held in a federal court.
• Class Action Lawsuit: In a class-action lawsuit, plaintiffs with similar injuries all combine into one single lawsuit.
• Individual lawsuits: In an individual lawsuit, the injured party sues the drug manufacturer directly both for the expenses that they have incurred as a result of their actions and for punitive damages.

Our firm works on a contingency basis which means you will not be asked to pay any money out of pocket.

This process will be very easy. Please feel free to answer all questions honestly as your information is confidential.