Actos Bladder Cancer Lawyer
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- Parent Category: Lawsuit News Alerts
- Category: Side Effects Lawsuit
Actos Bladder Cancer Lawyer
Actos Bladder Cancer Side Effects
Bladder cancer risk in patients using diabetes drug Actos dominated drug injury headlines in the United States and Europe for the last half of 2011. The top-selling diabetes drug with 60 percent of market share and $4.8 billion earning in 2010 was the number one choice of diabetics since 2007 following detection of cardiovascular risks linked to GlaxoSmithKline’s Avandia and consequent side effect lawsuits. Takeda Pharmaceuticals, the manufacturer of Actos, continues to claim that the drug helps reduce progression to Type 2 diabetes by 72%.
The recent discovery of Actos bladder cancer side effects risk, however, has raised safety concerns associated with the drug, and patients using the drug have flooded US courts, to file Actos related bladder cancer lawsuits. A report in Bloomberg has estimated that the total number of Actos side effect lawsuits could reach 10,000. On December 30, 2011, the Federal Judicial Panel on Multi District Litigation selected the Louisiana Western District federal court in Lafayette for consolidation of all Actos bladder cancer lawsuits.
Actos Bladder Cancer Side Effects Complaints
Actos is a class of drug known as thiazolidinediones and known as pioglitazone. Attorneys working with doihavealawsuit.com have stated that
Actos can increase the risk of bladder cancer in diabetics using it for more than one year. The risk rises with the increase in duration and cumulative dose of the drug. Actos bladder cancer lawyers have indicated that this paticular risk was discovered by FDA as early as September 2010 when a safety assessment by manufacturer Takeda hinted at the possibility of such danger. On June 9, 2011, the French Agency for the Safety of Health Products instructed Takeda to recall Actos following the discovery of comparatively higher bladder cancer risk in diabetes patients who took the drug. Next day, Germany’s Federal Institute for Drugs and Medical Devices suspended the sale of the Actos nationwide pending the conclusion of investigations into Actos bladder side effects and tumor dangers. On June 15th, the FDA warned consumers and doctors about the potential bladder cancer risk linked to Actos. It formally updated labels and added black box warning to the drug on August 5, 2011, informing patients about the risk.
Do i Have A Lawsuit Attorneys Investigate
Actos Bladder Cancer lawyer filed a class action lawsuit filed in Louisiana in September 2011 claims that manufacturer Takeda was aware of Actos bladder cancer side effects after a cancer study in 2005 resulted in the discovery of drug induced tumors in rats. However, the safety information was withheld by Takeda.
Actos Bladder Cancer Research Studies
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US FDA Report on Actos Bladder Cancer Risk
The federal regulator added black box warnings to Actos for bladder cancer side effects in June 2011, though it stopped short of recalling the drug pending further investigation. The FDA came to know about the Actos bladder cancer risk in September 2010 after mid-term report of a study sponsored by Takeda pointed to such a possibility. The drug safety study planned over 10 years concluded that the use of Actos for more than 24 months puts diabetes patients at a statistically higher risk of bladder cancer. The FDA has been conducting a comprehensive safety review of the drug since then. Its order on label change is viewed as an endorsement of the findings linking Actos to enhanced bladder tumor risk.
In May 2011, a meta-analysis report also highlighted "disproportionate bladder cancer risk” in diabetics taking Actos for a long time. The survey based on half million complaints against different diabetes medications received by the FDA adverse event reporting system highlighted that one-fifth of diabetics with bladder cancer were using Actos.
European MedicalAgency Study on Actos Bladder Cancer Risk
The European Medical Agency has also found a relatively higher risk of bladder cancer in Actos users. It used a public health alert in July 2011 cautioning doctors against prescribing the drug to patients with potential bladder tumor risk following a four-month safety review of the drug. The report of the study carried by EMA’s Committee for Medicinal Products for Human Use between March and June 2011 called for mandatory monitoring of patients during the first three to six months of Actos use. It advised doctors to follow patient selection and exclusion process before prescribing the drug to reduce Actos bladder cancer risk. The EMA also called for a pan-European epidemiological study on the risk of the drug among different age groups.
France Report on Actos Bladder Cancer Risk
Actos bladder cancer risk came to limelight following the decision by French national drug regulator to disallow the marketing of the drug. A clinical study commissioned by the French National Health Insurance first publicly highlighted a close association between the drug and bladder tumor. It evaluated cancer risk in 155,000 diabetes patients prescribed Actos and other pioglitazone drugs between 2006 and 2009. A comparative analysis of the risk results with similar threat to 1.3 million diabetics using other drugs disclosed that Actos users were 22 percent more prone to bladder cancer than patients taking other medications. The report concluded that patients with cumulative pioglitazone dosage of 28,000 mg or above face significant cancer risk.
Other Actos Side Effects Lawsuit
Actos also carries black box warnings for cardiovascular, macular edema, and bone fractures. According to FDA adverse reporting system and various studies, the following are notable Actos side effects.
- In 2003, a study conducted by the Mayo Clinic highlighted congestive heart failure cases in diabetes patients using Actos. In 2007, reports in New England Journal of Medicine (May issue) and Lancet journal (September) also reported such findings. The FDA updated labels on Actos in August 2007 to highlight the risk of heart failure in users. The drug can increase the cardiovascular risk in patients with heart complication by 70 percent.
Actos Macular Edema Side Effects:
In 2009,the American Journal of Ophthalmology reported 1,000 cases of macular edema in diabetics using Actos. According to the American Diabetes Association, Actos users are three to six times more prone to macular edema and resulting vision distortion. Excessive fluid retention because of the drug side effects is primary cause of edema in users.
- Actos Fracture Side Effect: Accordingtoa report in July 2010 issue of Clinical Endocrinology & Metabolism journal, Actos users are at the risk of fractures in spine, arm, and leg. The drug inhibits osteocalcin, responsible for formation of bone building cells, which is likely to cause osteoporosis and fractures in postmenopausal women.
- Actos Common Side Effects: Actos has also been linked to hypoglycemia, anemia, reduced hemoglobin level, weight disorder, liver damage, and other side effects in diabetes patients.
Do I have A Lawsuit affiliated attorneys are reviewing and processing Actos Bladder Cancer lawsuit investigations on your behalf.
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