Actos is a diabetes drug with global sales of approximately $4.8 Billion each year. Recent scientific evidence has shown that the Diabetes Drug Actos may cause an increased risk of bladder cancer. Further, several Actos Bladder Cancer Lawsuits are currently pending including a recent jury verdict that awarded over $9 Billion to the victims of Actos. If you have suffered a bladder cancer and were taking Actos or you have lost a loved one from bladder cancer and your loved one was taking Actos, please feel free to e-mail Texas Actos Bladder Cancer Lawyer Jason Coomer with your name & contact information or use our online form for a free case evaluation.
Actos Has Been Pulled Off the Market in Some European Countries
Actos has been prescribed to more than 10 million Americans since its approval for the treatment of type 2 diabetes. The popular diabetes drug, Actos, manufactured by Takeda Pharmaceutical Co, has been linked to increased risk of bladder cancer and has been pulled off the market in some European countries. Actos is now under review by the FDA to determine if it will be pulled from the market or additional black box warnings will be added to the drug.
FDA Drug Safety Communication: Ongoing Safety Review of Actos (pioglitazone) and Potential Increased Risk of Bladder Cancer After Two Years Exposure
On September 17, 2010, the U.S. Food and Drug Administration (FDA) announced that they are reviewing data from an ongoing, ten-year epidemiological study designed to evaluate whether Actos (pioglitazone), is associated with an increased risk of bladder cancer. Findings from studies in animals and humans suggest this is a potential safety risk that needs further study.
Actos is used along with diet and exercise to control blood sugar or improve control of blood sugar in adults with type 2 diabetes mellitus. Bladder cancer is estimated to occur in 20 per 100,000 persons per year in the United States and is thought to be higher in diabetics.1
The drug manufacturer, Takeda, has conducted a planned analysis of the study data at the five-year mark, and submitted their results to FDA. Overall, there was no statistically significant association between Actos exposure and bladder cancer risk. However, further analyses were also performed looking at how long patients were on Actos and the total amount of the drug they received during that time. An increased risk of bladder cancer was observed among patients with the longest exposure to Actos, as well as in those exposed to the highest cumulative dose of Actos.
At this time, FDA has not concluded that Actos increases the risk of bladder cancer. Its review is ongoing, and the Agency will update the public when it has additional information. Healthcare professionals should continue to follow the recommendations in the drug label when prescribing Actos. Patients should continue taking Actos unless told otherwise by their healthcare professional. Patients who are concerned about the possible risks associated with using Actos should talk to their healthcare professional.
This communication is in keeping with FDA's commitment to inform the public about its ongoing safety review of drugs.
The FDA recommends to patients that they do not stop taking Actos unless told to do so by your healthcare professional. FDA has not concluded that Actos increases the risk of bladder cancer. The Agency is reviewing this safety concern and will update the public when additional information is available. Talk to your healthcare professional if you have concerns about Actos. Report any side effects from the use of Actos to the FDA MedWatch program, using the information in the "Contact Us" box at the bottom of the page.
The FDA provided the following notice to Healthcare Professionals. The FDA has not concluded that Actos increases the risk of bladder cancer. The Agency is reviewing information related to the safety concern and will update the public when additional information is available. Follow the recommendations in the drug label when prescribing Actos. Continue to report adverse events involving Actos to the FDA MedWatch program.
Actos was approved July 15, 1999 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Across the approved doses Actos reduced HbA1c compared to placebo by an average of 1.5%.
In preclinical carcinogenicity studies of pioglitazone, bladder tumors were observed in male rats receiving doses of pioglitazone that produced blood drug levels equivalent to those resulting from a clinical dose. Additionally, results from two, three-year controlled clinical studies of Actos (the PROactive study2 and a liver safety study) demonstrated a higher percentage of bladder cancer cases in patients receiving Actos versus comparators. These findings are currently included in the Precautions--Carcinogenesis, Mutagenesis, Impairment of Fertility section of the Actos drug label.
To further address the long-term risk of bladder cancer associated with Actos use the drug manufacturer, Takeda, is conducting a ten-year, observational cohort study as well as a nested case-control study in patients with diabetes who are members of Kaiser Permanente Northern California (KPNC) health plan.3 Patients selected in this study had diabetes mellitus and were >40 years of age at study entry. Patients with bladder cancer prior to study entry or within six months of joining KPNC were excluded from this study. The cohort included 193,099 patients with diabetes.
The primary outcome of the cohort study is an incident (new) diagnosis of bladder cancer identified from the KPNC cancer registry. The primary exposure of interest is treatment with Actos. Data on drug dose, duration of exposure and potential confounding factors are also obtained in the study.
A planned five-year interim analysis was performed with data collected from January 1, 1997 through April 30, 2008. The median duration of therapy among Actos-treated patients was 2 years (range 0.2-8.5 years). The study investigators did not observe a statistically significant association between any Actos exposure and increased bladder cancer risk in the study (Hazard ratio = 1.2, 95% Confidence Interval: 0.9-1.5). However, the risk of bladder cancer increased with increasing dose and duration of Actos use, reaching statistical significance after 24 months of exposure.
FDA is reviewing the data from this observational cohort study and a case control study that is nested within it, and will update the public in several months when the review is complete or earlier should additional data become available.
Seer Stat Fact Sheets: Urinary Bladder. National Cancer Institute Web site. Bethesda, MD. http://seer.cancer.gov/statfacts/html/urinb.html. Accessed September 16, 2010. Dormandy JA, Charbonnel B, Eckland DJ, Erdmann E, Massi-Benedetti M, Moules IK, et al. Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial In macroVascular Events): a randomised controlled trial. Lancet. 2005;366:1279-89. Lewis JD, Ferrara A, Strom BL, Selby JV, Bilker W, Peng T, et al. The risk of bladder cancer among diabetic patients treated with pioglitazone: analysis through April 30, 2008. University of Pennsylvania and Kaiser Permanente Northern California Division of Research. Submitted to FDA, unpublished results.
- Related Information
FDA Drug Safety Podcast for Healthcare Professionals: Ongoing Safety Review of Actos (pioglitazone) and Potential Increased Risk of Bladder Cancer After Two Years Exposure Actos (pioglitazone): Ongoing Safety Review - Potential Increased Risk of Bladder Cancer MedWatch - 9/17/2010 FDA reviewing preliminary safety information on Actos (pioglitazone) FDA Note to Correspondents - 9/17/2010 SEER Stat Fact Sheets: Urinary Bladder Pioglitazone HCl (marketed as Actos, Actoplus Met, and Duetact) Information
Actos Bladder Cancer Lawsuit, Actos Lawsuit, Diabetes
Drug Lawsuit, Actos Cancer Lawsuit, and Actos Diabetes Drug
Actos banned in Europe after diabetes drug tied to cancer
June 10, 2011 10:04 AM
By Ryan Jaslow
The drug, Actos, has been pulled from the market in France and Germany after the popular diabetes drug was linked to bladder cancer. "The French Medicines Agency pulled Actos in addition to the pill Competact - a drug that combines Actos and the popular diabetes drug metformin - after a government-funded study found the drugs increased bladder cancer risk. The agency told French doctors to stop prescribing the drugs to patients, but said people currently using them should consult their doctors. German health officials followed suit after reviewing the French report, which tracked diabetics from 2006 to 2009."
"Robert Spanheimer, Takeda's vice president of medical and scientific affairs, told Reuters Health that the company hasn't had time to review the French study, but said two ongoing U.S. trials - including a 10-year trial started in 2003 - has yet to show bladder cancer risk."
The FDA has been reviewing Actos since September 2010, after reports that people who took the drug for over two years were at an increased risk for developing bladder cancer.
Bladder Cancer Stages, Bladder Cancer Symptoms,
Bladder cancers are classified, or staged, based on their aggressiveness and how much they differ from the surrounding bladder tissue. There are several different ways to stage tumors. Recently, the TNM (Tumor, Nodes, Metastasis) staging system has become common. This staging system categorizes tumors using the following scale:
Stage 0 -- Noninvasive tumors that are only in the bladder lining
Stage I -- Tumor goes through the bladder lining, but does not reach the muscle layer of the bladder
Stage II -- Tumor goes into the muscle layer of the bladder
Stage III -- Tumor goes past the muscle layer into tissue surrounding the bladder
Stage IV -- Tumor has spread to neighboring lymph nodes or to distant sites (metastatic disease)
Bladder cancer can metastasize or spread by extending into the nearby organs or through the lymph nodes. It can spread into the Prostate, Rectum, Ureters, Uterus, Vagina, Bones, Liver, and Lungs.
Bladder cancer can manifest through many different symptoms. Most of these symptoms can also occur with non-cancerous conditions. However, if you have these symptoms and a suspect bladder cancer, it is important to get evaluated by a qualified medical doctor to determine, if you may have bladder cancer. Some of these symptoms include: 1) Blood in the urine, 2) Painful urination, 3) Urinary frequency, 4) Urinary urgency, 5) Abdominal pain, 6) Anemia, 7) Bone pain or tenderness, 8) Lethargy or fatigue, 9) Urinary incontinence, and 10) Weight loss.
Testing for bladder cancer can include performing 1) a physical examination, including a rectal and pelvic exam, 2) Abdominal CT scan, 3) Bladder biopsy (usually performed during cystoscopy), 4) Cystoscopy (examining the inside of the bladder with a camera), 5) Intravenous pyelogram - IVP, 6) Urinalysis, and 7) Urine cytology.
There are several types of treatment for bladder cancer. The selection of treatment for bladder cancer will vary depending on the patient, health care provider, and stage of bladder cancer. In Stages 0 and I, surgery is usually performed to remove the tumor without removing the rest of the bladder. Also, chemotherapy or immunotherapy can be applied directly into the bladder. People with stage 0 or I bladder cancer can be treated with transurethral resection of the bladder (TURB). This surgical procedure is performed under general or spinal anesthesia. A cutting instrument is inserted through the urethra to remove the bladder tumor.
In Stages II and III treatment, chemotherapy can be used to shrink the tumor before surgery, then surgery can be performed to remove the entire bladder (radical cystectomy) or surgery can be performed to remove only part of the bladder, followed by radiation and chemotherapy. For bladder cancer patients that cannot have surgery or choose not to have surgery, a combination of chemotherapy and radiation can be used.
Many people with stage II or III bladder cancer may need to have their bladder removed (radical cystectomy). Partial bladder removal may be performed in some patients. Removal of part of the bladder is usually followed by radiation therapy and chemotherapy to help decrease the chances of the cancer returning. Patients who have the entire bladder removed will receive chemotherapy after surgery to decrease the risk of the cancer coming back.
Radical cystectomy in men usually involves removing the bladder, prostate, and seminal vesicles. In women, the urethra, uterus, and the front wall of the vagina are removed along with the bladder. Often, the pelvic lymph nodes are also removed during the surgery to be examined in the laboratory.
A urinary diversion surgery (a surgical procedure to create an alternate method for urine storage) is usually done with radical cystectomy. Two common types of urinary diversion are an ileal conduit and a continent urinary reservoir. An ileal conduit is a small urine reservoir that is surgically created from a small segment of bowel. The ureters that drain urine from the kidneys are attached to one end of the bowel segment. The other end is brought out through an opening in the skin (a stoma). The stoma allows the patient to drain the collected urine out of the reservoir. People who have had an ileal conduit need to wear a urine collection appliance outside their body at all times. A continent urinary reservoir is an alternate method of storing urine. A segment of colon is removed. It is used to create an internal pouch to store urine.
This surgery is becoming more common in patients undergoing cystectomy. A segment of bowel is folded over to make a pouch (a neobladder, which means "new bladder"). Then it is attached to the place in the urethra where the urine normally empties from the bladder. This procedure allows patients to maintain some normal urinary control. However, there are complications (including urine leakage at night). Urination is usually not the same as it was before surgery.
Unfortunately, for most patients with stage IV tumors, the bladder cancer cannot be cured and surgery will not appropriate. In these stage IV bladder cancer patients, chemotherapy is often considered.
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Texas Dangerous Drug Attorney Jason Coomer commonly works with other lawyers throughout Texas, the United States, and the World including Houston Actos Bladder Cancer Lawyers, San Antonio Bladder Cancer Lawyers, Dallas Actos Lawyers, New York Actos Lawyer, Chicago Actors Lawers, and other Texas Actos Bladder Cancer Lawyers. By sharing information and working together, his law firm and other firms throughout World are able to provide better representation for there clients.
If you have suffered a bladder cancer or
have lost a person that you love from a bladder cancer or
heart problems and you or your loved one was taking Actos,
please feel free to e-mail Texas Actos Bladder Cancer Lawyer
Jason Coomer with your name & contact information or
use our online form for a free case evaluation.