Actos Bladder Cancer Side Effects Lawsuit
Actos Bladder Cancer Lawsuit
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
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 face22 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 Congestive Heart Failure
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 Fracture Risk
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.
Actos Side Effects
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.
Actos cardiovascular side effects, including angioneurotic edema leading to breathing difficulty in patients using the drug along with insulin. Fluid retention due to the drug also results in congestive heart failure in users.
Actos endocrine side effects, including hypoglycemia and weight disorder.
Actos hematologic side effects, including anemia and decrease in hemoglobin level leading to disturbance in oxygen transportation.
Actos hepatic side effects, including liver damage and jaundice.
Actos ocular side effects, including central vision distortion, macular edema, impaired visual acuity, and blindness.
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.