Actos, a pioglitazone-based drug, is widely used by Type 2 diabetes patients. With above-60 market share, the diabetes pill was among the top 10 most selling drugs in the United States in 2008 and 2009, despite the fact that it carries black box warnings for heart failure, edema, and fractures in the bone. However, the disclosures about Actos bladder cancer risks in June last year have resulted in the recall of the drug in France and Germany. The FDA has issued the strongest possible warnings and updated labels for Actos bladder cancer risk while the European Medical Agency has called for strict monitoring of patients prescribed the drug.
On December 30, 2011, the US Judicial Panel on Multidistrict Litigation centralized all Actos bladder cancer lawsuits filed in federal courts across the country for coordinated and consolidated pretrial proceedings at the Louisiana Western District federal court. Hundreds of lawsuits, claiming Actos caused plaintiffs to suffer from bladder cancer side effects, have been filed in various states since the FDA health alert in June 2011 warned Actos users of increased bladder tumor risk. An Actos class action lawsuit filed in Louisiana on September 16, 2011 seeks medical and financial compensation from manufacturer Takeda for all Actos users who suffered from bladder cancer since 1999. The number of lawsuits is expected to go beyond 10,000 in the coming months, as consumer groups and lawyers are running campaigns to educate Actos users with bladder cancer about their right to file drug injury lawsuits.
Actos bladder cancer risk was first reported in September 17, 2010. A drug safeActos Bladder Cancer Lawyer communication issued by the FDA disclosed that the regulator was reviewing the findings of an ongoing epidemiological study that suggested association between Actos and increased risk of bladder tumors in both animals and humans. The FDA admitted to have received 31 bladder cancer complaints from patients prescribed Actos through its Adverse Event Reporting System between 2004 and 2009. It advised Actos users and healthcare professionals to report incidences of blood in the urine, increase in urination frequency, and pain during urination, which are key bladder cancer symptoms, to FDA’s MedWatch without further delay. Subsequent reports and findings have suggested that the intake of the drug for more than 12 months or in higher dosages leads to 42 percent increase in bladder cancer risk.
Manufacturer Takeda Pharmaceutical was aware of bladder cancer risks associated with the drug prior to its approval in 1999. Researchers found drug-induced cancer in male rats receiving Actos during a two-year carcinogenicity study. Results of a three-year PROspective Pioglitazone Clinical Trial in Macro Vascular Events published in Lancet journal in 2005 also reported similar findings.
In 2002, manufacturer Takeda commissioned a 10-year study on safety concerns related to Actos. According to reports based on the first five-year findings, the drug use can enhance bladder cancer risk in a patient by 40 percent. It linked the increase in risk to the highest dosages and long duration of use.
As soon as the interim Takeda findings are out, the FDA issued a drug safety communication informing users of Actos bladder cancer risk and ordered for comprehensive review of the drug in September 2010. On June 15, 2011, it announced that people using Actos for more than a year face greater bladder cancer risk. Within two months, it updated the black box warning on the drug and revised its label to include information linking Actos to bladder tumors.
A research report prepared by the American Diabetes Association in early 2011 also confirmed presence of bladder cancer risks in Actos users. Published in Diabetes Care, the study focused on Actos side effects complaints reported to FDA Adverse Event Reporting System between 2004 and 2009. It called for more research on the link between Actos and bladder tumor. Another meta-analysis of half million adverse health problem complaints received by the FDA reported in May 2011 also highlighted “disproportionate bladder cancer risk” in Actos users.
A study by Kaiser Permanente Northern California has also revealed that diabetes patients taking Actos for more than a year or with higher doses are 40 percent more prone to develop bladder cancer compared to users of other diabetes drugs. The survey took into account 190,000 Type 2 diabetes patients above 40 years of age.
A French study published in June 2010 caused worldwide action by national regulators against Actos bladder cancer risk. The research funded by the French National Health Insurance made a comparative bladder cancer analysis of Actos and non-Actos diabetes patients. It examined tumor risk in 155,000 Actos users and compared it with similar risk in 1.3 million non-Actos diabetes patients. The report concluded that cancer risk in Actos patients was 22 percent higher than patients using other diabetes drugs. It also reported that patients with cumulated Actos dose exceeding 28,000 mg face greater bladder tumor risk.
A four-month study carried on by the European Medical Agency between March and June 2011 also confirmed association between pioglitazone and bladder cancer in users. A health alert issued by the EMA in July 2011 favored continuous monitoring of Actos users, particularly during first six months. The Committee for Medicinal Products for Human Use advised healthcare professionals to screen patients for cancer risk before prescribing Actos.
Other Actos side effects
According to a report in Bloomberg, Takeda Pharmaceuticals may face more than 10,000 Actos side effect lawsuit over allegations linking the drug to bladder cancer and a host of adverse reactions in users. Actos has been the top-selling diabetes drug since 2007 after GlaxoSmithKline’s Avandia, another popular diabetes drug, lost ground following a spate of lawsuit linking it to cardiovascular and other fatal side effects. However, a mid-term FDA study report published in September 2010 disclosed that diabetes patients taking the drug face greater threat of suffering from bladder cancer.
In June 2011, the federal regulator warned about the risk of bladder cancer in patients using Actos for more than 12 months. The FDA has been monitoring the safety concerns related to the drug since last September. The disclosures prompted immediate withdrawal of the drug in France and Germany while a four-month study by the European Medical Agency also confirmed the potential cancer risk associated with Actos.
A large number of research reports have shown that Actos, known by its generic name pioglitazone, has a number of side effects that outweigh its benefits in the long run.
Actos Bladder Cancer Lawsuit Attorney
On June 15, 2011, a public health alert by the FDA highlighted a link between bladder cancer in diabetes patients and Actos side effects. It warned about higher risk of cancer in patients using the drug regularly for more than 12 months. The regulator was aware of Actos cancer side effects as early as September 2010 after the mid-term report of its 10-year long commissioned safety study came out. The FDA has warned healthcare professionals against prescribing Actos to patients with prior record of bladder cancer.
A study commissioned by the French National Health Insurance Fund has also found heightened bladder cancer risk in 155,000 diabetes patients in France treated with Actos from 2006 to 2009. According to the report, the Actos users with cumulative dosage exceeding 28,000 mg face
22 percent higher cancer risk. The European Medical Agency also conducted a study between March and June 2011 and expressed similar apprehensions and called for screening and six-month monitoring of diabetes patients using Actos.
Actos side effects can cause severe cardiovascular problems similar to Avandia, according to a report in Circulation, the mouthpiece of the American Heart Association. The report also claimed that the drug increases congestive heart failure risk in patients with heart problems and kidney dysfunction. A Mayo Clinic study in 2003 highlighted six cases of Type 2 diabetes patients taking Actos were hospitalized following pulmonary edema, fluid retention, and congestive heart failure caused by the drug side effects. A report in May 2007 issue of the New England Journal of Medicine also expressed similar apprehensions.
The FDA notified a Congressional hearing in June 2007 about the need for adding black box warning on cardiovascular problems. The updated label changes, published two months later, warned about fluid retention and other such conditions caused by the drug that can lead to heart failure. According to a Lancet journal report published in September 2007, Actos increases heart failure risk in diabetics with prior history of heart diseases by more than 70 percent.
Actos side effects can cause osteoporosis and fractures in postmenopausal women users. A study published in the Journal of Clinical Endocrinology & Metabolism in July 2010 reported that the drug could increase spine, arm, and leg fractures in women diabetics by 1.5 times. The study covering around 3,500 patients also linked fracture risk to the duration and amount of Actos dosage. A trial conducted by Wake Forest University doctors in 2009 found that Actos and other TZDs inhibit osteocalcin activity in the body, which weakens bones. A group of researchers from California and result of a Swiss bone fracture study made similar claims in 2008. In 2007, the FDA and manufacturer Takeda issued public health alerts warning consumers about the risk of fractures.
Actos Macular Edema
Macular edema is an important Actos side effect that can lead to vision loss in Type 2 diabetes patients, according to the American Diabetes Association. A presentation at ADA’s San Diego annual meet highlighted that users could face the risk of macular edema and vision distortion by three to six times. The study conducted by researchers at the University of Nottingham took into account about 100,000 diabetic patients and found that the Actos group has more people with diabetic macular edema than other medicine groups. The American Ophthalmology Academy annual meet in 2003 also blamed Actos and similar glitazone-class drugs for rising macular edema and vision loss cases among working-age Americans with diabetes. In April 2009, a study in the American Journal of Ophthalmology highlighted 1,000 edema cases among 17,000 Type 2 diabetics using Actos.
The FDA has added black box warnings on Actos for cardiovascular, edema, and possible fractures. The following are some of the important Actos side effects on various body systems.
Within the first few months of the FDA blood cancer warning, hundreds of Actos side effect lawsuit have been filed across the United States against manufacturer Takeda and distributor Eli Lilly for hiding information on safety concerns. While 16 lawsuit await proceedings in the Louisiana west federal court, more than 50 cases have been filed in Illinois. The number is increasing, and it is expected to touch 10,000 lawsuit very soon. An Actos class action lawsuit has been filed in Louisiana east federal court accusing Takeda and Eli Lilly of canceling information on Actos side effects leading to blood cancer risk for financial gains.