Liability for Avandia lawsuits could total as much as $6 billion, according to a UBS analyst. GlaxoSmithKline, the maker of Avandia, faces more than 13,000 U.S. lawsuits over the controversial diabetes drug.

Avandia has been the subject of safety concerns for several years. In November 2007, a black box warning – the Food & Drug Administration (FDA’s) strongest safety warning – detailing Avandia’s association with myocardial ischemia was added to the drug’s labeling. The black box was added after the Cleveland Clinic published a meta- analysis of 42 clinical trails that showed patients taking Avandia had a 43-percent higher risk of having a heart attack. More Avandia Lawsuits Could Cost Glaxo as Much as $6 Billion

Avandia’s cardiovascular problems have long been the subject of concern and controversy. Now, reports FiercePharma, an adverse event (AE) report for last year’s third quarter indicated that GlaxoSmithKline’s Avandia (generic: rosiglitazone) was number one on the list. The Institute for Safe Medication Practices issued the report.

The diabetes drug Avandia, was reported 1,218 times; 1,000 were serious or ended in death, said FiercePharma. Seroquel (generic: quetiapine), AstraZeneca’s antipsychotic medication, followed with 977 reports, according to FiercePharma. Lioresal (generic: baclofen), made by Novartis had 796 adverse event reports; fentanyl, a pain medication, 688; and Enbrel (generic: etanercept), manufactured by Amgen and Pfizer for rheumatoid arthritis and psoriasis, was cited 495 times. The report includes information from an array of sources and the Institute follows adverse event reports for some 2,000 medications, said FiercePharma. More Avandia, Seroquel Have Most Adverse Event Report

An Avandia lawsuit has been filed by California’s Santa Clara County, charging GlaxoSmithKline with false advertising, and seeking billions in compensation for Californians who took the controversial diabetes drug. According to the MercuryNews.com, the lawsuit was spurred by a recent Senate report on Avandia that accused Glaxo of withholding information about the drug’s heart risks.

Avandia’s cardiovascular problems have been the subject of concern since May 2007, when a meta- analysis of 42 clinical trails published by the Cleveland Clinic showed that patients taking the drug had a 43-percent higher risk of having a heart attack. In November 2007, a black box warning – the Food & Drug Administration (FDA’s) strongest safety warning – detailing Avandia’s association with myocardial ischemia was added to the drug’s labeling. More California Avandia Lawsuit Seeks Billions in Compensation

GlaxoSmithKline is defending its controversial diabetes drug, Avandia, following the release of a Senate Finance Committee report that charged the drug maker downplayed the drug’s heart risks. According to The Associated Press, in a 30-page “white paper”, Glaxo claims the Senate report “mischaracterizes and distorts” the company’s record.

Avandia’s cardiovascular problems have been the subject of concern since May 2007, when a meta- analysis of 42 clinical trails published by the Cleveland Clinic showed that patients taking the drug had a 43-percent higher risk of having a heart attack. In November 2007, a black box warning – the Food & Drug Administration (FDA’s) strongest safety warning – detailing Avandia’s association with myocardial ischemia was added to the drug’s labeling. More GlaxoSmithKline Goes to Bat For Avandia

Authors of Avandia papers who had financial ties to the drug industry were more likely to write favorably of the controversial diabetes drug, and report that it did not increase the risk of heart attacks, says a new study. According to a report on TheHeart.org, the Avandia study was presented as a poster by Dr Mohammed Hassan Murad of the Mayo Clinic at the American College of Preventive Medicine’s (ACPM) annual meeting.

Murad and colleagues performed a review of 202 articles that addressed the possible association between the risk of heart attacks and use of Avandia in diabetes patients. Two reviewers who were blinded to the authors’ financial relationships evaluated each article and classified it as being favorable (supporting the argument that the drug does not increase the risk of heart attack), neutral, or unfavorable (questioning Avandia’s safety), TheHeart.org said. Of the articles reviewed, 107 (53%) included a conflict-of-interest statement and 90 (45%) had a conflicting financial relationship. More Avandia Papers Influenced by Financial Relationships, New Study Says

The latest Avandia controversy has put the Food & Drug Administration (FDA) in a rather unfavorable light. According to The Wall Street Journal, the Senate Finance Committee’s Avandia report that we detailed over the weekend is putting pressure on the agency to reform its drug safety program.

As we reported over the weekend, the Senate report found that in July 2007 the FDA’s own scientists estimated that Avandia was responsible for more than 80,000 heart attacks. The report maintains that some of those could have been avoided if GlaxoSmithKline had considered Avandia’s cardiovascular risks in 1999 when they were first raised. Instead, the report says Glaxo tried to undermine criticism of the drug. More Avandia Debacle Puts FDA on the Spot

Newly released Avandia reports link the controversial diabetes drug to tens of thousands of heart attacks. What’s more, some Food & Drug Administration (FDA) drug reviewers have concluded that Avandia should be removed from the market. Meanwhile, a Senate Finance Committee report released yesterday says GlaxoSmithKline knew for years about Avandia’s heart attack risks, but took steps to keep the public in the dark.

Avandia’s cardiovascular problems have been the subject of concern since May 2007, when an analysis of 42 clinical trails published by the Cleveland Clinic showed that patients taking the drug had a 43-percent higher risk of having a heart attack. In November 2007, a black box warning – the FDA’s strongest safety warning – detailing Avandia’s association with myocardial ischemia was added to the drug’s labeling. Since the May 2007 study highlighting Avandia’s heart risks was released, thousands of people injured by the drug have filed lawsuits against Glaxo. More Avandia Linked to Thousands of Heart Attacks, FDA Reviewers Urge it be Removed from The Market

Thiazolidinediones, a class of diabetes drugs which include Avandia and Actos, may put women at a higher risk of bone fractures, according to a new study. The study, which was conducted by the Center for Health Services Research at Henry Ford Hospital and published in the February issue of the Journal of Clinical Endocrinology & Metabolism, is one of the one of the largest to examine the longitudinal relationship between drugs like Actos and Avandia and fractures.

To determine the relationship between thiazolidinedione use and fracture risk in patients with type 2 diabetes, researchers conducted a retrospective study from Jan. 2, 2000 to May 31, 2007 of 19,070 Henry Ford patients. Among the study group, 9,620 were women and 9,450 were men. During the study period, 4,511 patients had at least one prescription fill for a thiazolidinedione. The researchers used electronically maintained medical claims data to identify non-traumatic bone fractures. More Avandia, Actos Up Fracture Risk for Women, Study Finds

A federal judge overseeing the Avandia multidistrict litigation has ordered GlaxoSmithKline to produce dozens of documents in a lawsuit over Avandia’s heart side effects. In doing so, the judge rejected Glaxo’s claim that the documents were subject to attorney-client or work product privilege.

Avandia’s cardiovascular problems have been the subject of concern since May 2007, when an analysis of 42 clinical trails published by the Cleveland Clinic showed that patients taking the drug had a 43-percent higher risk of having a heart attack. That summer, GlaxoSmithKline, the maker of Avandia and the Food & Drug Administration (FDA) came under fire for an apparent failure to warn the public about the cardiac risks associated with Avandia. More Glaxo Documents in Avandia Lawsuit Must Be Produced

The diabetes drug Avandia has been linked to so many health problems that some have questioned whether or not it should be on the market at all.

In November 2007, a warning detailing Avandia’s association with myocardial ischemia was added to the drug’s boxed warning. The warning followed an analysis of 42 clinical trails published by the Cleveland Clinic in May 2007 that found patients taking Avandia had a 43-percent higher risk of having a heart attack. That summer, GlaxoSmithKline and the Food & Drug Administration (FDA) came under fire for an apparent failure to warn the public about the cardiac risks associated with Avandia. More Avandia Linked to Heart Attacks, Liver Failure, Other Health Woes