Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE

FDA Explores Actos Cancer Link

By Drug Discovery Trends Editor | September 20, 2010

WASHINGTON (AP) – The Food and Drug Administration is reviewing data suggesting a possible link between the widely used diabetes medication Actos and bladder cancer.

The agency said Friday that five-year results from an ongoing study show that patients who have taken Actos for the longest period of time had a higher risk of bladder cancer. Bladder cancer was also more prevalent in patients who had taken the largest cumulative dose of the drug.

Actos manufacturer Takeda Pharmaceuticals is conducting the study, which is scheduled to run 10 years.

“The agency has not concluded that Actos increases the risk of bladder cancer,” the agency said in a statement. Patients should continue taking Actos unless told otherwise by their doctor, according to the agency statement.

Actos agreed to study the risk of bladder cancer with its drug in 2003. But a company executive said Friday the results are too preliminary to make any conclusions about the drug.

“This interim analysis raises a question, but it doesn’t answer anything,” said Dr. Robert Spanheimer, vice president of medical affairs at Takeda. “We are committed to finishing the study because I think that’s when you’re going to get the greater understanding.”

Prescriptions for Actos have risen since 2007, when its chief competitor, Avandia, was first associated with cardiovascular problems. The FDA is considering whether to withdraw Avandia, which is marketed by British drugmaker GlaxoSmithKline. Actos and Avandia work similarly to control blood sugar and are the only drugs in their class currently on the market. A third drug called Rezulin was withdrawn in the U.S. in 1997 due to liver toxicity.

Critics of Avandia have called on the FDA to recall the drug, arguing that Actos offers the same benefits without risks of heart attack and stroke.

The FDA’s review of Actos’ cancer risks is preliminary, but could shape its decision on Avandia, which is expected in coming weeks.

U.S sales of Actos have risen steadily – hitting $3.4 billion last year – as Avandia’s reputation has soured. Last year Avandia posted $520 million in sales.

Headquartered in Osaka, Japan, Takeda Pharmaceuticals Co. is the country’s largest drugmaker. Its U.S. operations are based in Deerfield, Ill.

Date: September 17, 2010
Source: Associated Press


Filed Under: Drug Discovery

 

Related Articles Read More >

EVEREST lead investigator on why Dupixent sets a new bar for treating coexisting CRSwNP and asthma
Sanders, King target DTC pharma ads but the industry worries more about threats to its $2B R&D model
Zoliflodacin wins FDA nod for treatment of gonorrhea
FDA approved ENFLONSIA for the prevention of RSV in Infants
“ddd
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in the drug discovery and development industry.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Drug Discovery and Development
  • MassDevice
  • DeviceTalks
  • Medtech100 Index
  • Medical Design Sourcing
  • Medical Design & Outsourcing
  • Medical Tubing + Extrusion
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE