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Actos Heart Attack Lawsuit | Actos Lawsuits

Actos Heart Attack Injury Lawsuits. If you or someone you love have used the diabetes drug Actos, and suffered an Actos heart attack, this popular type 2 diabetes drug could be to blame. Recent research has linked Actos and other type 2 diabetes drugs known as thiazolidinediones with the side effects of heart attacks, strokes […]

Actos Heart Attack Actos Heart Attack Injury Lawsuits. If you or someone you love have used the diabetes drug Actos, and suffered an Actos heart attack, this popular type 2 diabetes drug could be to blame. Recent research has linked Actos and other type 2 diabetes drugs known as thiazolidinediones with the side effects of heart attacks, strokes and other cardiovascular problems. If you or a loved one suffered an Actos heart attack or other heart problem while taking Actos due to its side effects, you may be able to file an Actos heart attack lawsuit to obtain compensation for your medical bills, lost wages, pain and suffering, and other damages.

The Actos side effect lawyers at Parker Waichman LLP are offering FREE Actos lawsuit evaluations to victims of Actos heart attacks and other Actos cardiovascular problems. To learn more about filing an Actos heart attack lawsuit, and to protect your legal rights, please contact the Actos side effect lawyers at Parker Waichman LLP today.

Actos Heart Attack Risks

Actos was brought to market by Takeda Pharmaceuticals in 1999. By 2010, it was Takeda’s top-selling product, racking up sales of $4.78 billion in the U.S. alone. Actos was one of three type 2 diabetes drugs known as thiazolidinediones which were designed to increase the cell’s sensitivity to insulin. The two other thiazolidinediones that were brought to market have been the subject of controversies because of their dangerous side effects. The thiazolidinedione Rezulin was recalled in March 2000 because of its serious liver side effects, and after being implicated in nearly 400 deaths. Avandia, another thiazolidinedione, has had its sales severely restricted because of its association with heart attacks, strokes and other cardiovascular problems.

In 2002, the package label for Actos was updated to include a warning regarding the risk of Actos heart side effects “In insulin combination studies, a small number of patients with a history of previously existing cardiac disease developed congestive heart failure when treated with ACTOS in combination with insulin,” the warning stated.

In a study released August 24, 2010, Actos was found to have the same dangerous heart side effects as Avandia. The study conducted by HealthCore Inc., analyzed the medical records of 28,938 people from 2001 to 2005 who took either Avandia or Actos. The data showed that about 4 percent of each group died from heart failure or a heart attack. According to the study, 121 patients taking Actos suffered a heart attack, while 96 patients had a heart attack while taking Avandia. Heart failure was noted in 243 patients taking Actos compared with 265 who were taking Avandia. A total of 18 patients on Actos suffered both a heart attack and heart failure, while 24 taking Avandia suffered from both conditions. Finally, an equal number of Actos and Avandia patients – 217 – died from a heart attack or heart failure while using the drugs.

The link between Actos and heart failure is strong enough that in 2007 the U.S. Food & Drug Administration (FDA) strengthened the warnings on the Actos label concerning congestive heart failure. Information regarding Actos’s association was heart failure was placed in a “Black Box” warning, the FDA’s most serious safety alert.

Actos Bladder Cancer Side Effects and Actos Bladder Cancer Lawsuits

Actos has also been associated with a higher risk of bladder cancer among long-term users. In June 2011, the FDA issued a safety communication stating that use of Actos for more than one year may be associated with an increased risk of bladder cancer. The June safety communication was a follow-up to one the agency issued in September 2010 after preliminary data from a study conducted by Kaiser Permanente demonstrated that the risk of bladder cancer rises with increasing dose and duration of Actos use, reaching statistical significance after 24 months. Bladder cancer concerns also caused regulators in France and Germany to suspend sales of Actos in those countries in June 2011. Takeda officially recalled Actos from the French market the following month.

Actos and Liver Cancer

The Actos lawyers at Parker Waichman LLP are investigating other cancers that might be associated with Actos use, including liver cancer. If you or someone you love developed liver cancer while taking Actos, our Actos side effect lawyers would like to hear from you. Parker Waichman is offering free lawsuit evaluations to any type 2 diabetic who has taken Actos and been diagnosed with liver cancer.

Actos and Prostate Cancer

The Actos lawyers at Parker Waichman LLP are also investigating any possible links between Actos and prostate cancer. If you are a man who took Actos to treat type 2 diabetes, and developed prostate cancer, we urge you to contact our Actos lawyers today for a free lawsuit evaluation.

Actos and Kidney Cancer

The Actos lawyers at Parker Waichman have begun investigating any possible association between use of Actos and kidney cancer. Our Actos lawyers would like to speak with any type 2 diabetic who developed kidney cancer during or after treatment with Actos.

Actos Timeline

Jul. 15, 1999: The U.S. Food and Drug Administration (FDA) approves Actos to treat patients diagnosed with type 2 diabetes mellitus. The drug is launched by manufacturers Takeda Pharmaceutical and Eli Lilly & Co.

Oct. 13, 2000: The European Medicines Agency (EMA) approves Actos to treat type 2 diabetes mellitus

2006-2009: As part of a government funded study, data is collected from diabetic patients taking Actos in France

Aug. 14, 2007: FDA releases a safety alert concerning Actos and other similar drugs, to include a new “boxed” warning on their labels. The agency stated that the alert was meant “to emphasize that pioglitazone may cause or exacerbate heart failure, particularly in certain patient populations.” The blackbox warning was addressed to Takeda and GlaxoSmithKline, who manufactures Avandia

Apr. 2009: Takeda buys back the rights to Actos from Eli Lilly in seven countries including Canada, Sweden and Norway. In explaining the motive behind this strategic move, Takeda said it was an effort to increase “the enhancement of our presence in each region of the world to further establish Takeda as a world-class pharmaceutical company.” cites FiercePharma

Jan-Oct 2010: At outpatient retail pharmacies, an estimated 2.3 million patients fill a prescription for Actos or medication containing Actos, according to the FDA

Sept. 17, 2010: The FDA is conducting an ongoing safety review concerning the increased risk of bladder cancer associated with exposure to Actos. The agency states that it is analyzing data from an ongoing ten-year study looking at the relationship between the drug and bladder cancer. Although some findings in animal and human studies suggest a possible connection, the FDA does not make any definitive statement about the link between Actos and bladder cancer.

Jun. 2010: A Whistleblower suit is filed against Takeda Pharmaceutical Co. Under the False Claims Act, former medical reviewer Helen Ge, files a suit on the government’s behalf alleging that cases of congestive heart failure “were not properly identified or reported in the FDA’s safety database,”

Mar. 16, 2011: By request of the European Commission, the EMA’s Committee for Medicinal Products for Human Use CHMP starts a review of Actos, Glustin, Competact, Glubraca and Tandemact to analyze the use of these medications related to the risk of bladder cancer.

Jun. 9, 2011: The EMA issues a press release concerning findings from the French Medicines Agency, and its decision to suspend Actos from the market. The EMA does not make any definitive claims at this point, but states that ongoing reviews will continue.

Jun 10, 2011: Use of Actos is banned in France and Germany. The French Medicines Agency removed the drug from the market after analyzing the data collected from 2006 to 2009.

Jun. 15, 2011: FDA announces “that use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer.” Warning labels are to be updated subsequently. The agency warns healthcare professionals against prescribing Actos in patients who have bladder cancer or have a history of bladder cancer.

Jul. 2011: The EMA states that Actos should include the risk of bladder cancer on its warning label, according to Reuters.

Dec. 2011: Takeda may face over 10,000 lawsuits, according Bloomberg Businessweek

Mar 12, 2012: Jerrold Parker, co-founder of Parker Waichman LLP, is named to the Plantiffs’ Steering Committee, in the multidistrict litigation (MDL) No. 2299.

References:

  • http://www.bloomberg.com/news/2012-03-07/takeda-hid-actos-linked-heart-failure-cases-whistle-blower-claims-in-suit.html
  • http://www.taf.org/whyfca.htm
  • http://www.fda.gov/Drugs/DrugSafety/ucm259150.htm
  • http://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm109136.htm
  • http://www.fiercepharma.com/story/takeda-buys-back-lillys-actos-rights/2009-04-09
  • http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000285/human_med_000624.jsp&mid=WC0b01ac058001d124

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