Key Dates in the Efforts to Prove that Actos Causes Bladder Cancer

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Key Dates in the Efforts to Prove that Actos Causes Bladder Cancer Powered By Docstoc
					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 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
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 the rights to market the
drug in the US and other countries previously served by Eli Lilly.
On September 17, 2010, the FDA issued a notification to doctors and their
diabetic patients, in which the FDA announced its was reviewing the
initialdata from a 10-year epidemiological study on Actos.
Epidemiological studies 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 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 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 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 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 bladder cancer hazard
before they take the drug. Interestingly, this upgrade in the warning
from the FDA was based on the same information that was available back in
September 2010, much of which 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 to the
FDA's analysis did not show that there was an -œoverall increased risk
ofbladder cancer-• among Actos users. (This -œoverall-• 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 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
-œdose-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 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 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
sforHumanMedicalProd. For more information visit

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