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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
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.
Healthcare professionals and patients can access the latest drug labels for pioglitazone-containing medicines at: Actos (pioglitazone) Actoplus Met (pioglitazone/metformin) Actoplus Met XR (pioglitazone/metformin extended-release) Duetact (pioglitazone/glimepiride)
FDA Drug Safety Communication: Update to ongoing safety review of Actos (pioglitazone) and increased risk of bladder cancer
Pioglitazone HCl (marketed as Actos, Actoplus Met, and Duetact) Information
Comunicado de la FDA sobre la seguridad de los medicamentos: Actualización de las etiquetas de los medicamentos que contienen
Labeling and Regulatory History from Drugs@FDA
Pioglitazone HCL (marketed as Actos) Prescribing and Labeling Information
Pioglitazone HCl and Metformin HCl (marketed as Actos Met) Prescribing and Labeling Information
Pioglitazone HCl and Metformin HCl(marketed as Actos Met XR) Prescribing and Labeling Information
Pioglitazone HCl and Glimepride(marketed as Duetact) Prescribing and Labeling Information
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Announcement: Over-the-Counter (OTC) Drugs Now FSA Reimbursable IRS Revenue Ruling 2003-102, released September 3, 2003, permits many OTC drugs purchased without a physician’s prescription to be reimbursed through a health care flexible spending account (FSA), as long as the items alleviate illness or injury. Below are examples of medical-only and dual purpose OTC
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