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Key Dates in the Efforts to Prove that Actos Causes Bladder CancerArticle Summary: To fully understand the Actos claims that Powers Taylor LLP is handling against Takeda and Eli Lilly, one must appreciate the time-line of plaintiffs' efforts to prove that Actos causes bladder cancer.

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To fully understand the Actos claims that Powers Taylor LLP is handling against Takeda and Eli Lilly, one must appreciate the time-line of plaintiffs' efforts to prove that Actos causes bladder cancer.
July 15, 1999. Actos was initially introduced to consumers in the United States in July 1999. Takeda, the Japanese company that manufactured the drug, enlisted the assistance of Eli Lilly & Company, an established U.S. pharmaceutical company, as its marketing partner in the [url=http://www.shujufenxishi.com/?p=1#comment-21141]What Is A Real Estate Relocation Company[/url] United States.
2005. Takeda initiates a ten-year study to determine potential side effects of the drug, by comparing the rate of illnesses and ailments [url=http://www.ieluxury.fr/louboutin-pas-cher/]boutique louboutin paris[/url] among Actos users to the rate of those same illnesses and ailments among non-users who are otherwise similar to the Actos users.
April 2009. Takeda and Eli Lilly announce that their partnership for marketing Actos was coming to an end, with Takeda buying back [url=http://www.elpas.fr/category/doudoune-moncler-france/]doudoune moncler france[/url] the rights to market the drug in the US and other countries previously served by Eli Lilly.
On September [url=http://www.cdille.fr/category/louboutin-pas-cher-femme/]louboutin pas cher femme[/url] 17, 2010, the FDA issued a notification to doctors and their diabetic patients, in which the FDA announced its [url=http://www.jeremyparendt.com/Barbour-Paris.php]barbour france paris[/url] was reviewing the initialdata from a 10-year epidemiological study on Actos. Epidemiological studies [url=http://www.gerardodambrosio.it/scarpe-hogan-outlet/‎]scarpe hogan outlet[/url] gather information from two or more distinct groups, and then compare the rates of certain diseases or ailments between the two groups. In this Actos study, one group consisted of diabetic patients who took Actos, and the other group was made up of diabetic patients who controlled their diabetes by other means. Although the 10-year study was only halfway complete, the FDA wanted to examine preliminary data because the agency felt that animal studies suggested that there was a chance that Actos caused bladder cancer.
When Takeda sent the results from the first five years of the Actos study to the FDA, Takeda took the position that there was no problem with Actos. However, the FDA did further analysis of the raw data in the [url=http://www.usjfan.com/cgi-local/bbs/shop/bbs110.cgi?start=30%22]moncler sito ufficiale In Wha[/url] study, andthe government agency became concerned that for patients who took the drug for more than a year, or who took the drug for higher than average doses, the 5-year study suggested a link between Actos and bladder cancer, because the frequency of bladder cancer went up in the sub-groups that took the drug longer. The [url=http://www.cdille.fr/category/louboutin-soldes/]louboutin soldes[/url] FDA wanted to collect more information on the long-term Actos users to see if the relationship between length-of-use and higher bladder cancer rates held true for the sixth [url=http://www.jewelmer.fr/category/jordan-basket/]air jordan basket[/url] through tenth years of thestudy.
In the September 17, 2010 notice, the FDA also asked doctors to send in reports if any of their diabetes patients on Actos were also diagnosed with bladder cancer.
By June 15, 2011, less than 9 months after [url=http://www.aparteprato.it/category/piumini-moncler-outlet/]piumini moncler outlet[/url] the original Actos - bladder cancer notice from the FDA, the agency upgraded the urgency of their Actos warning. In this bulletin, the FDA announced that new information about the link between Actos and bladder cancer would be added to the Warnings and Precautions section of the drugs label. These drug labels must accompany every package of the drug, so it is one of the FDA's most effective ways to ensure that the general public learns about the [url=http://www.skoda-witzke.de/hollister-deutschland/]hollister online shop[/url] bladder cancer hazard before they take the drug. Interestingly, this upgrade [url=http://www.ieluxury.fr/louboutin-pas-cher/]louboutin boutique[/url] in the warning from the FDA was based on the same information that was available back in September 2010, much of which [url=http://www.leherodeslapins.fr/hollister-france-magasin/]Hollister France Magasin[/url] had been available toTakeda long before that date.
The new information that was required on the label stated that the use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer.
In support of this more stringent warning, the FDA cited two authorities. First, the FDA cited the five-year interim study, which according [url=http://www.ieluxury.fr/louboutin-pas-cher/]louboutin femme pas cher[/url] to the FDA's analysis did not show that there was an "overall increased risk ofbladder cancer" among Actos users. (This "overall" finding simply meantthat enough short-term and low-dose users of Actos had been included in the study by Takeda to dilute the statistical findings among users who took the drug for more than a year.) However, the FDA [url=http://www.ieluxury.fr/louboutin-pas-cher/]louboutin homme pas cher[/url] now concluded that the five-year results showed an increased risk of bladder cancer among the diabetics who took the largest quantities of the drug. This type of "dose-response" relationship is a classic indicator of a causalrelationship between a toxic substance and the onset of cancer.
Second, the FDA cited a epidemiological study that had been conducted in France. The French study felt like the data conclusively proved the link between Actos and bladder cancer. Based [url=http://www.jb-pr.co.uk]Hollister UK[/url] on that study, the FDA's counterparts in France had suspended all sales of Actos in France, and the counterpart in Germany recommended that German doctors phase out the use ofActos [url=http://blog.veralana.com/2013/11/22/last-leaves/#comment-54503]The Different Kinds Of Internet Affiliate Marketing[/url] by not prescribing the drug to new patients.
The FDA told doctors not to prescribe Actos to any patient that had bladder cancer (either now or in the past). The FDA further assured the doctors and the public that it would continue to monitor the ongoing epidemiological study being conducted by Takeda.
August 4, 2011, the FDA announced its approval of the updated drug labelsfor Actos (and other pioglitazone-containing medicines). These updated labels had been revised by Takeda in response to the new requirements forwarnings that had been announced almost two-months earlier.
As this timeline shows, Takeda most likely had information about apotential Actos - bladder cancer link for years before the public received a new warning in August 2011. The company had begun a study on the issueat least 5 years before September 2010. Plaintiffs in these suits continueto question why this link with a deadly form of cancer was not studied prior to the introduction of the drug to the US market. If you or a family member took Actos and later developed bladder cancer, then contact the Actos lawyers at Powers Taylor LLP for a free case evaluation.
August 23, 2011. Lawsuits filed naming Takeda and Eli Lilly, claiming Actos caused bladder cancer.
You can view the actual FDA alerts on Actos at the following location:
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