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

The U.S. Food and Drug Administration (FDA) said it plans on stepping up its prosecutions of pharmaceutical and food industry executives as part of its work to revamp the agency’s criminal division said the Wall Street Journal. It seems the division has been derided by Congress and was recently condemned in a government report, added the Journal.

The FDA recently wrote to Senator Chuck Grassley (Republican-Iowa), saying that an internal committee recommended that the agency and its Office of Criminal Investigations (OCI) “increase the appropriate use of misdemeanor prosecutions, which allows responsible corporate officials to be held accountable and is a valuable enforcement tool,” quoted the Journal. According to the FDA, it has authority to “prosecute corporate executives for criminal actions” under a provision entitled “strict liability.” Although not enacted to a great extent in recent years, the FDA spokesman said that the government is not required to prove intent to defraud in order to convict. More FDA to Increase Use of Criminal Prosecutions

Merck & Co. has made a final $4.1 billion payment to its Vioxx settlement fund. According to an Associated Press report, final payouts to former Vioxx users or their survivors should be made by the end of June.

Vioxx was approved for use in 1999, and quickly became a bestseller for Merck, with annual sales of $2.5 billion; however, the painkiller was pulled off the market in 2004 after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003. The withdrawal prompted thousands of product liability lawsuits that claimed Merck didn’t properly warn doctors and patients of the drug’s risks.
More Vioxx Settlement Almost Wrapped Up

A federal appeals court has ruled that a Paxil suicide lawsuit is not preempted. As such, the lawsuit, which was filed by the parents of Tricia Mason, will move forward. Mason was only 23 when she took her own life just two days after taking Paxil.

In its unanimous ruling, the 7th Circuit cited the “clear evidence” standard set last year by the U.S. Supreme Court in Wyeth vs. Levine. In that case, the High Court decided to let stand a Vermont Supreme Court ruling that upheld a jury verdict against Wyeth over deficient labeling related to the IV push injection of Phenergan. In that case, the Court held that there could only be preemption if the manufacturer presented “clear evidence” that the Food & Drug Administration (FDA) would have rejected the proposed additional warning. More Paxil Suicide Lawsuit Not Preempted, Appeals Court Rules

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

We have long been writing about a series of problems with K-V Pharmaceutical Company. In December, K-V Pharmaceutical said that the U.S. Food and Drug Administration (FDA) accepted its work plan to address the issues. Now, KV Pharmaceutical said it will be closing down its ETHEX generic drug unit, wrote The Associated Press (AP). The drug maker will also plead guilty to criminal charges that allege ETHEX neglected to appropriately advise regulators about significant manufacturing problems that posed dangers to consumers, wrote the AP.

Last March, we wrote that the U.S. Food and Drug Administration (FDA) announced that a Consent Decree of permanent injunction was filed enjoining KV Pharmaceutical Company, its subsidiaries ETHEX Corporation and Ther-Rx Corporation, and its principal officers, from making and distributing adulterated and unapproved drugs. That move followed an extensive series of incidents regarding KV Pharmaceuticals and its subsidiaries. More KV Pleads Guilty, Agrees to Close ETHEX Generic Drug Plant

New Jersey has become the latest venue where Yaz and Yasmin lawsuits have been consolidated as a mass tort. The consolidation was ordered on February 18 by New Jersey’s Administrative Office of the Courts. The Yaz and Yasmin lawsuits have been assigned to Judge Brian R. Martinotti in Bergen County Superior Court.

Yaz and Yasmin are both made with a type of progestin called drospirenone, making them different from many other oral contraceptives. Drospirenone can elevate the body’s potassium levels, which can lead to a condition called hyperkalemia in certain patients. Hyperkalemia may result in potentially serious heart and health problems. Adverse Events reported to the Food & Drug Administration (FDA) involving Yaz and Yasmin include heart arrhythmias, electrolyte imbalance, hyponatremis, hyperkalemia, hyperkalemic arrhythmias, atrial fibrillation, tachycardia, bradycardia, myocardial infarction, stroke, transient ischemic attack, blood clots, embolisms, and sudden death. More More Yaz, Yasmin Lawsuits Consolidated

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