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Pharmaceutical industry

FDA Requires Warning Label for Diabetes Medication Actos

Strategic Insights

— 1 min read

The U.S. Food and Drug Administration (FDA) required added warnings on the label of the diabetes medication Actos (pioglitazone) on June 15, 2011, stating that it may increase the risk of bladder cancer when taken for more than one year. This warning came after France and Germany suspended the use of pioglitazone. Meanwhile, the European Medicines Agency (EMA) announced that Actos may be put back on the European market with new contra-indications.

Key Takeaways:

  • The FDA required added warnings on the label of Actos (pioglitazone) stating that it may increase the risk of bladder cancer when taken for more than one year.
  • France and Germany suspended the use of pioglitazone.
  • The European Medicines Agency (EMA) announced that Actos may be put back on the European market with new contra-indications.
  • The EMA advises physicians to carefully monitor patients and review them after three to six months (and regularly thereafter) while they continue to analyze their data.
  • The FDA will continue to review the data that comes in from the ongoing, ten-year US epidemiological study.
  • Attorney David Ennis commented on the ongoing data analysis, stating that patients are expected to "wait and see" while the data is further analyzed.
  • Ennis & Ennis, P.A. continues to investigate bladder cancer claims relating to Actos.
  • Bladder cancer symptoms include blood in urine, painful urination, frequent small amounts of urination, frequent urinary tract infections, lower back pain, and abdominal back pain.
  • Patients who have taken Actos (pioglitazone) and experienced these symptoms should first immediately consult with their physician, then fill out a MedWatch Form with the FDA, and seek the opinion of an experienced lawyer.
  • Ennis & Ennis offers free nationwide confidential consultations for patients who are taking or have taken Actos and suffer these symptoms.

Statistics:

  • 10 years: the duration of the ongoing US epidemiological study.
  • 1 year: the timeframe after which the risk of bladder cancer from Actos increases.
  • $100 million: the total amount of settlements recovered by Ennis & Ennis, P.A. for its clients.
  • 1986: the year Ennis & Ennis, P.A. began representing clients individually.

Sources:

  • Ennis & Ennis, P.A.
  • FDA: Food and Drug Administration
  • European Medicines Agency (EMA)
  • PRWeb: On August 01, 2011

http://www.prweb.com/releases/2011/8/prweb8676201.htm

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