- Ennislaw

08/21/2011 - On August 4, 2011, the U.S. Food and Drug Administration (FDA) approved added warnings on the label of the Type II diabetes medication Actos, after reporting that its sole ingredient, pioglitazone, may increase the risk of bladder cancer (bladder tumors). According to Ennis & Ennis, P.A., the updated drug labels recommend that healthcare providers should not use pioglitazone in patients with active bladder cancer and should use pioglitazone with caution in patients with a prior history of bladder cancer. Pioglitazone is also sold as a combination drug under the names of Actoplus Met and Duetact.

Meanwhile, the European Medicines Agency (EMA) temporarily suspended the sale of Actos in June and July 2011, but they have now allowed it back on the market with new contra-indications because the “benefit-risk balance remains positive in a limited population of Type II diabetics”. The EMA’s new warning recommends that prescribers review the treatment of new patients on pioglitazone after three to six months and further recommends that prescribers start elderly patients on the lowest possible dose, as they are at a higher risk for bladder cancer.

These new warnings were prompted by an intermediate analysis of a 10-year clinical study, which indicated a significant increase in bladder cancer among patients taking the drug, particularly with those who used Actos for more than one year. The study is still underway and the manufacturers, Japan-based Takeda pharmaceuticals, insist on completing the 10-year analysis. According to Business Week, Actos had sales of $4.6 billion in the fiscal year ending March 31, 2010, making it Takeda’s best selling drug. The FDA and EMA continue to analyze their data to determine if the bladder cancer is an early effect or a risk with prolonged use and/or high cumulative dose.

Bladder cancer symptoms may include: blood in urine, painful urination, frequent small amounts of urination, frequent urinary tract infections, lower back pain, and abdominal back pain.

Attorney David Ennis recommends that anyone who has taken pioglitazone-containing medications such as Actos, Actoplus or Duetact, and experienced any of these symptoms should first immediately consult with their physician. Next, the patient should fill out a MedWatch Form at www.fda.gov. Lastly, patients should seek the opinion of an experienced lawyer to explore their legal rights.

Ennis & Ennis P.A. is offering free nationwide confidential consultations for patients who are taking or have taken Actos, Actoplus or Duetact and suffer these symptoms by calling toll free 1-800-856-6405 or by going to www.ennislaw.com and completing an online case evaluation form.

Ennis & Ennis, P.A. is a nationwide law firm with offices in Ft. Lauderdale, Miami and Washington D.C. Ennis & Ennis, P.A. specializes in mass torts and represents individuals against pharmaceutical companies worldwide as well as medical device makers.

Ennis & Ennis, P.A. has been representing clients individually since 1986 and has recovered over $100 million in settlements for its clients.

Ennis & Ennis, P.A. is also investigating cases involving, Accutane, Avandia, Fosamax, Transvaginal Mesh Devices, Paxil, Zoloft, Prozac, Depuy Hip Recall, Zimmer Hip Recall, Depakote, Reglan, SJS/Dilantin, Yaz, Yasmin and Ocella Birth Control Pills.

Remember the law limits the time in which you can file a claim so don't wait to explore your legal rights. Call today toll free 1-800-856-6405 or visit www.ennislaw.com.

More Actos Bladder Cancer Lawsuit News::

If you have taken Actos and experienced serious Actos side effects such as Actos Bladder Cancer call our Actos lawyer today to find out about an Actos lawsuit. With offices in Washington D.C. and throughout Florida we are ready to help Actos side effects victims nationwide. Let our Actos Attorneys evaluate your case for free today. Fill out our online case evaluation form on this page or call us toll free at: 1.800.856.6405 for your free, confidential case evaluation.

Under no circumstances should you discontinue taking any medication, including Actos or Pioglitazone, without first consulting with your doctor.

Actos Bladder Cancer Side Effects Lawsuit Information::