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Sort by date 131 pages found matching Glaxo- FDA Medical Reviewer Slams RECORD Trial Conclusions, Casting Further Doubt on Avandia
Jul-9-10 Washington, DC The US Food and Drug Administration (FDA) today stated through a posting on the official FDA website that GlaxoSmithKline (Glaxo), the manufacturer of Avandia , may have misinterpreted crucial details of a study that it said had vindicated Avandia and found the Type 2 diabetes drug to be safe. A medical reviewer with the FDA said that,... - Avandia Maker Cited by the FDA
Apr-15-08 Washington, DC In what appears to be an epidemic amongst drug manufacturers, the US Food and Drug Administration (FDA) has taken Avandia maker GlaxoSmithKline to task for withholding information about the drug long suspected of harboring a higher risk of heart attack than patients on other diabetes drugs. A stern warning letter was forwarded to Glax... - What will be the Heir to Avandia's Troubled Throne?
Nov-14-07 Washington, DC: While Avandia has proven to be a drag on public relations, and the bottom line for GlaxoSmithKline (GSK), the troubled diabetic drug's propensity for causing heart attack and weight gain is not causing the British drug manufacturer any undue hardship. In fact, third-quarter (Q3) results released November 6th by Chief Financial Office... - Avandia Drug Maker Accused of Bullying Critics
Aug-9-07 Washington, DC An FDA Committee recently heard testimony from several scientists that suggests that early critics of the diabetes drug Avandia were intimidated by drug maker GlaxoSmithKline. Congressional investigators are examining what they call "very serious" claims that Glaxo "silenced one or more medical professionals who attempted to speak out... - Part 1: Avandia and the FDA: The Bottom Line
Jun-19-07 Washington, DC The FDA has come under vocal criticism in the last three weeks over its handling of Avandia , the widely-prescribed GlaxoSmithKline diabetes drug. The FDA's supporters and its critics are still offering their views of what happened, what should have happened, and what should happen in the future. As regular readers will know, Avandia wa... - Paxil Birth Defect Trial Tossed Out of Court
Dec-1-10 Summerville, SC It was a heartbreaking end to a Paxil birth defects trial in Philadelphia, after a judge ended the proceedings at about the midway point, finding for GlaxoSmithKline (Glaxo), the defendant. The lawsuit, the first Paxil trial to be undertaken since Glaxo agreed in July to settle 800 cases by paying out more than $1 billion, attempted to... - Avandia Decline Not Affecting GlaxoSmithKline
May-3-09 Philadelphia, PA While profits may have been down in the first quarter when compared to a year ago, Avandia manufacturer GlaxoSmithKline (Glaxo) appears to be doing well. And while the risk for heart attack and other Avandia side effects continues for Type 2 diabetes patients—and critics continue to lobby for an Avandia recall—Glaxo's own health appe... - Avandia Researcher Under Fire
Jun-8-07 Cleveland, OH Over the past few days reports have surfaced about the risk of heart attacks associated with diabetes drug Avandia. Since the findings of a study that showed an increased risk of heart attack in patients taking Avandia were published, reports have surfaced that both the Food and Drug Administration (FDA) and GlaxoSmithKline, the drug's manu... - Avandia Maker Tried to Silence Doctor who had Concerns
Jun-5-07 Washington, DC: A noted diabetes specialist who first raised the red flag on the diabetic drug Avandia in 2000, claims that the drug manufacturer attempted to gag his criticism and quash his findings, to the point where a colleague refused to write prescriptions for Avandia because GlaxoSmithKline was giving his friend such a hard time. Worse, alleged... - Pharmaceutical Sales Overtime Debate Will Go On
Apr-21-11 Portland, OR Long after the last appeal has been filed and the final arguments made, debate will continue to rage over whether or not individuals performing in pharmaceutical sales are entitled to overtime pay. Pharmaceutical reps promote the products of their employers—which are then prescribed to patients by doctors and dispensed through pharma... - Former Glaxo Executive Indicted
Nov-10-10 Durham, NC A long-promised crackdown on pharmaceutical executives accused of potential wrongdoing is gaining momentum with the indictment yesterday of a former vice president and legal counsel of GlaxoSmithKline (Glaxo). While the pharmaceutical giant is headquartered in the UK, its US operations are based in North Carolina. The New York Times reporte... - Paxil Off-Label Use to Be Focus of Heart Defects Trial
Apr-18-10 Washington, DC Paxil manufacturer GlaxoSmithKline (Glaxo) faces hundreds of Paxil lawsuits alleging that the antidepressant causes birth defects. Next up at the plate is Delaney Novak, a little girl born on April 4, 2002 with heart defects. In June, her parents Laura and Derek will contend that misconduct on the part of Glaxo over safety warnings for P... - Avandia Heart Attack: Questions Still Remain
Sep-30-08 Washington, DC The Avandia debate continues to provide a basis for confusion in the face of conflicting information. GlaxoSmithKline (Glaxo), the makers of Avandia, continues to claim that studies conclude there is no risk of heart attack . However, questions remain. Why does Avandia carry a black box warning? And why was there never an Avandia recall ?... - The FDA Guerillas of Wonky DrugWonks - Part I
Aug-12-08 Former Bush Administration officials have formed a pharmaceutical industry guerilla group called the Center for Medicine in the Public Interest (CMPI), described on its website as "a non-partisan, non-profit educational charity," and a "new vital force in health care policy." However, for all intents and purposes, the mission of CMPI front group is to pr... - Part 2: Avandia, the FDA and the consumer: first lawsuit filed
Jun-25-07 Beaumont, TX: It is now one month since GlaxoSmithKline's popular diabetes drug Avandia was reported to carry with it a higher risk of heart attack—and just two days ago, on June 19, what is likely the first lawsuit blaming Glaxo for contributing to just such a heart attack, was filed. Larry Alan Stanford, 60, of Beaumont, Texas, suffered a hear... - GlaxoSmithKline Sued Over Paxil Birth Defects
Jul-29-06 A lawsuit was filed against GlaxoSmithKline on July 28, 2006, in Philadelphia on behalf of Adrian Vasquez, who was born on April 19, 2004, with birth defects as a result of his mother having been prescribed Paxil during pregnancy. Paxil belongs to the class of antidepressant drugs known as selective serotonin re-uptake inhibitors (SSRIs). At birth, Ad... - Zantac Medication Cancer Legal News & Lawsuit Information
Zantac (ranitidine hydrochloride) is being investigated after 150 Zantac tablets were found to contain a carcinogenic chemical up to 3,000 times greater than the FDA’s daily intake limit. The chemical found in the popular heartburn drug is N-nitrosodimethylamine (“NDMA”). Numerous studies have shown a link between the NDMA in Zantac and can... - Coming Out from the Shadow of Paxil Birth Defects
Dec-13-11 Washington, DC Anyone sitting on the fence over whether or not to go after GlaxoSmithKline (Glaxo) over Paxil side effects need only contemplate the reported $3 billion that Glaxo has agreed in principal to pay, in order to settle charges of off-label marketing and fraud. Combine that figure with the reported $1 billion Glaxo is believed to have pai... - Was GlaxoSmithKline Worried About Avandia Risks?
Sep-23-09 Seattle, WA For patients who take Avandia, learning about the risk of Avandia side effects may have come as a complete surprise before the strengthened warnings were added in 2007. However, reports have surfaced that GlaxoSmithKline, maker of Avandia, may have known about the risks before studies were released questioning the drug's safety. An arti... - SSRI Antidepressants causing suicidal behavior
With recommendations from the Psychopharmacologic Drugs Advisory Committee and the Pediatric Drugs Advisory Committee, the Food and Drug Administration (FDA) announced a Public Health Advisory directing antidepressant manufacturers to expand their warning label on October 15, 2004. While the FDA's recommended "Black Box" warning label is extens...