(PRWEB) October 26, 2011
On October 21, 2011, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) clarified its opinion on pioglitazone-containing anti-diabetes medications, such as Actos, and the risk of bladder cancer on the request of the European Commission. According to Ennis & Ennis, P.A., the Committee reported that due to the bladder cancer risk posed by pioglitazone, which is the sole ingredient in Actos, the medication may remain a valid treatment option for certain patients with Type II diabetes, but only when other treatment options are not suitable or have failed to work adequately.
In June 2011, France and Germany temporarily suspended the use of pioglitazone, but then put it back on the market with new contraindications, advising physicians to carefully monitor the patients and to review the patients after three to six months (and regularly thereafter) while the EMA continued to analyze their data to determine if the bladder cancer was an early effect or a risk with the prolonged use/high cumulative dose.
In August 2011, in response to the EMA’s warning, the U.S. Food and Drug Administration (FDA) approved updated drug labels indicating that patients who use the drug for more than a year may face an increased risk of bladder cancer.
Currently there are an increasing number of lawsuits being filed against Japan-based Takeda Pharmaceuticals alleging that the drug manufacturer filed to provide adequate warnings of the risk of bladder cancer. Many of the complaints further allege that Takeda should have removed Actos from the market, as the risk of bladder cancer outweighs the minimal benefits.
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.
Pioglitazone is also sold as a combination drug under the names of Actoplus Met and Duetact.
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 http://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 http://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. that concentrates its practice in mass torts, representing individuals against pharmaceutical companies, as well as medical device manufacturers.
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 http://www.ennislaw.com.
# # #