Actos® Bladder Cancer
Oral diabetes medication Actos® (generic name pioglitazone) is made by Takeda Pharmaceutical Company and co-marketed in the United States by Eli Lilly Pharmaceuticals. Actos® and related drugs are used to control type-2 diabetes in patients whose condition is not adequately controlled by diet and exercise alone.Actos® belongs to a class of drugs called Thiazolidinedione drugs, which help to treat Type-2 diabetes by lowering blood glucose levels and increasing the body's sensitivity to insulin. This drug may be prescribed alone (as Actos®) or in combination with other active ingredients such as metformin (sold as Actoplus met) or glimepiride (sold as duetact). A patient's drug regiment may also include insulin or other medications in addition to those containing pioglitazone.
Actos® Bladder Cancer - Black Box Warning
Currently there is no Actos® black box warning.(Aug. 22, 2010) Howevere there has been an intense debate over the safety of Type-2 diabetes drugs in general, the FDA has asked the makers of Actos® to issue a black box warning. A black box warning is the strongest FDA-requested label change that can be added to a drug. Check with the FDA for the most current information about the status of a black box warning for Actos®.
Additionally the FDA is currently analyzing the clinical data and studies of Actos® to determine whether further regulatory action, such as an Actos® recall, is warranted. Actos Bladder Cancer was never warned of to the Actoc diabetic users
Actos® Increases Bladder Cancer Risk
FDA recently issued a drug safety communication warning patients and health professionals that use of pioglitazone (Actos?Takeda) for more than 1 year may be associated with an increased risk of bladder cancer. A French study, conducted by the nation's health insurance agency, examined cancer rates and found an increasing risk in bladder cancer.
A 2007 study with over 200,000 Medicare patients pointed to Avandia's (generic: rosiglitazone) increased heart attack risks, "cardiovascular disease, stroke, and death by 30-to-40 percent," versus other, older diabetes medications, said the LA Times. That study indicated that the risk was not seen with Actos® (generic: pioglitazone). The study prompted stronger U.S. Food and Drug Administration (FDA) label warnings, with even stronger warnings following more reports of increased risks with Avandia, said the LA Times; an FDA panel found the benefits of Avandia outweighed its risks and that it should remain on the market, but that no more patients be enrolled in a prospective study comparing the two drugs directly.
The team, led by Debra Wertz an outcomes research manager at HealthCore Inc., a Wellpoint Inc. research subsidiary?analyzed 28,938 patient records for people who took either medication from 2001 to 2005, obtaining company data, said the LA Times. Death information was derived from the National Death Index, which is managed by the National Center for Health Statistics. The research appears in the journal Circulation: Cardiovascular Quality and Outcomes.
When accounting age gender, and prior heart disease, about four percent per group either suffered a heart attack or heart failure or died, said the LA Times. The figures break down to 96 Avandia, versus 121 Actos® patients suffering a heart attack and 265 Avandia and 243 Actos® patients suffering from heart failure, said the LA Times; 217 in each group died.
Actos® Bladder Cancer Lawsuit
If you or a family member took Actos® (pioglitazone) and have developed bladder cancer, we encourage you to contact a pharmaceutical lawyer at our firm immediately. An experienced pharmaceutical products liability lawyer at the Willis Law Firm can discuss with your your legal right in potential lawsuit for Actos Bladder Cancer injuries against the makers of the drug.
We will contact you within 4-12 hours for a free confidential Actos® Bladder cancer case review. Contact our law firm immediately so that we may explain the rights and options available to you and your family.