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GSK Posts Q4 Loss after Avandia Settlement

(London, UK – February 10, 2011)

GSK Posts Q4 Loss after Avandia Settlement

(Courtesy Photo)

GlaxoSmithKline (GSK) posted Thursday a net loss of 690 million pounds ($1.12 billion) after taking a 2.2 billion pound charge for the Avandia settlements.

GSK is the world’s third leading pharmaceutical company with over 90,000 employees all around the world. It has a portfolio of products for major diseases like asthma, cancer, virus control, infections, mental health, diabetes and digestive conditions.

On Thursday, the company posted a net loss for the three months-ending on December 31, 2010, compared with a profit of 1.63 billion pounds from the previous year. Its revenue, on the other hand, fell as much as 13 percent to 7.19 billion pounds. As a result, the company announced that it will reinstate its share buyback program.

Analysts said that the decline in profits for the pharmaceutical company was brought by the various lawsuits filed against its popular drugs like Avandia and Paxil.   On January 31, GSK took 2.2 billion pounds from its reserve to settle claims relating to Avandia and past U.S. litigation over the sales practices of the product. Avandia is an oral anti-diabetic agent which acts primarily by increasing insulin sensitivity.

This drug was marketed by GSK as a stand-alone, which improves glycemic control while reducing circulating insulin levels. In 2007, the U.S. Food and Drug Administration (FDA) began an investigation of the drug, which according to several meta-analyses is associated with an increased risk of myocardial ischemic attacks. Later that year, the federal department added a black box warning on the drug, stating therein its contraindications to patients with symptomatic heart failure.

In 2008, GSK was ordered to withdraw due to the Avandia side effects, alongside the accusations that the company allegedly concealed the drug’s health risks at the time when they were trying to win FDA approval. Those who used Avandia and later developed heart problems were advised to contact an Avandia attorney to help them file an Avandia lawsuit against GSK, and provide legal assistance on how to claim compensation for medical costs and other losses.

FDA Updates Info Guide on Avandia Side Effects

(February 10, 2011)

FDA Updates Info Guide on Avandia Side Effects

(Courtesy Photo)

U.S. Food and Drug Administration (FDA) announced Thursday that updated information of Avandia side effects has been added to physician labeling and patient Medication Guide.

The FDA, a federal agency of the United States, is responsible for protecting and promoting public health through the regulation and supervision of food safety, medications, and several other products. They first announced the new restrictions for prescribing and use of Avandia on September 23, 2010, after several studies showed the drug increased risk of heart failure and other cardiovascular complications.

Avandia, genetically known as rosiglitazone, is an oral anti-diabetic agent marketed by GlaxoSmithKline, the world’s third largest pharmaceutical company based in London, UK. This anti-diabetic drug, which acts primarily by increasing insulin sensitivity, improves glycemic control while reducing circulating insulin levels. It was initially approved by the FDA on May 25, 1999.

In 2001, FDA questioned GSK for downplaying the potential possibilities of heart failure associated with its manufactured anti-diabetic drug. The risks were confirmed by the pharmaceutical company in 2005, saying that there may be a number of health risks attributed to the drug. In 2007, a meta-analysis of 42 clinical studies showed that the drug is associated with an increased risk of myocardial ischemic attack, including angina and myocardial infarction.

In May 2007, the FDA ordered a full withdrawal of Avandia from the market, saying the drug increases the risk of heart attacks by 43 percent and the risk of cardiovascular death by 60 percent. As of last year, GSK reached settlement agreements amounting to $520 million to settle more than 10,000 suits against it. Early this year, the pharmaceutical company agreed to pay $3.5 billion to settle an Avandia lawsuit filed by a patient who died of a heart attack after taking the anti-diabetic drug. A company representative said that the settlement means other Avandia lawsuits have been resolved.

GlaxoSmithKline Whistleblower: False-Claims Lawsuit Involving Popular Drugs Including Avandia and Paxil

Three months ago, pharmaceutical maker GlaxoSmithKline agreed to pay $750 million to resolve a U.S. government false-claims lawsuit over charges that the company knowingly manufactured and sold adulterated drugs. The affected medications involved in the suit included the heavily prescribed antidepressant, Paxil and Avandia, a medication taken for type II diabetes.

This week, the whistleblower responsible for bringing to light the disturbing problems at a Glaxo plant, that resulted in the false-claims lawsuit, spoke out for the first time on 60 minutes. In her interview, the former Glaxo global quality assurance manager, Cheryl Eckard, made public the unconcealed disregard shown by the company for the safety and quality of the products they manufacture.

Cheryl Eckard first learned of issues when she was sent to evaluate a Glaxo factory in Cidra, Puerto Rico and noted numerous production problems causing some drugs to become tainted, mislabeled, or incorrectly dosed. Eckard told 60 Minutes reporter Scott Pelley “All the systems were in disrepair, the facility was in poor condition, the equipment was in disrepair, the processes were broken. It was the worst thing I had run across in my career.”

Eckard alleges that after eight months of reporting these issues with no company response, she produced a chart for Glaxo executives showing nine problem areas at the Cidra plant. The chart included allegations that production issues at the plant were causing powerful drugs to be mixed together in the same bottles.

According to Eckard, her claims continued to be dismissed; and after a pharmacist reported a mix-up involving incorrectly labeled Paxil prescribed to an 8-year-old boy, the drug company filed a report with the FDA saying it was extremely unlikely that the drug mix-up occurred at Cidra. Cheryl Eckard was let go shortly after her letter to company executives detailing problems at Cidra. After Eckard was fired, she brought her complaints to the FDA.

In 2005, Cidra was raided and Federal investigators said that the conditions of the Glaxo factory were far from meeting public health standards. Cidra was shut down in 2009 and is no longer owned by GlaxoSmithKline.

Under the federal False Claims Act, whistleblowers like Eckard may be entitled to receive a portion of any money that the government recovers from the offenders. In order to receive a portion of the recovered money, the whistleblower must be the first to bring the case to the government’s attention, and must not publicize the claim until the DOJ decides to prosecute the claim. Cheryl Eckard received a record $96 million from the settlement.

Glaxo to Face a $3.4 B Settlement on Avandia Lawsuit

Reports said Monday that GlaxoSmithKline is bound to face a multi-district litigation amounting to an estimated $3.4 billion against its anti-diabetes drug, Avandia.

According to the reports, a number of pending litigations against Avandia, an oral anti-diabetic agent which acts primarily by increasing insulin sensitivity, are filed in different states of America. Federal courts’ records show that more than 50,000 complaints were reported against the adverse effect of Avandia.

In 2010, Glaxo already settled an approximated 10,000 Avandia cases with an average settlement of $460 million. On Monday, another lawsuit was heard in the US District Court for the Eastern District of Pennslyvania. The lawsuit involves a claim filed by the relatives of James Buford, a diabetic patient who had been taking Avandia for 15 months, after the latter died of heart attack.

The incident proves a meta-analysis of 42 clinical studies, saying that daily intake of the anti-diabetes drug can relatively increase the risk of myocardial ischemic attack such as angina pectoris and myocardial infarction. Buford’s lawyer argued that approximately three weeks after Buford started taking Avandia, the patient suffered symptoms that suggested a mild heart attack. Earlier this month, Glaxo announced that it was reserving $ 3.4 billion to cover the contingency loss brought by the Avandia lawsuits.

Meanwhile, a second trial against Avandia is scheduled to begin on March 28 this year, which involves a patient who allegedly used the drug and suffered congestive heart failure from Avandia. Experts said that Avandia has caused 60,000 and 200,000 heart attacks and deaths due to cardiovascular problems in the United States from 1999 to 2006. Glaxo is currently under investigation by the US Department of Justice and several other state lawyers for potential fraud.

China to monitor the anti-diabetes drug Avandia

Chinese health officials announced that they will closely monitor any issues and concerns about the anti-diabetes drug Avandia.

After the rise of relative concerns about the use of the drug in the U.S. and Europe, Shanghai’s Food and Drug Administration officials said that they will watch over the drug and will look for any problems that the drug may cause to the Chinese people. Furthermore, they claimed that the Chinese government is currently making communication and collaborating with other local health facilities to tackle the issue.

Shanghai officials asked GlaxoSmithKline who manufactured the drug to gather any information regarding the adverse effects of the drug within the country. Furthermore, they asked them to report any cases of severe reaction and deaths with the use of the drug.

In the U.S., federal regulatory agency issued additional warning for the anti-diabetic drug Avandia. Earlier than that, the Europe’s regulatory agency banned the drug for selling and usage in their countries. This happened after some studies suggested that the drug might cause increased risk of heart attacks and deaths.

Dr. Jia Weiping, director of the Shanghai Diabetes Institute, said that because of these sequence of events, the Chinese health agency raised concerns about the drug, which seems to be a popular drug to treat diabetes. The State Food and Drug Administration of China will be conducting meeting today to talk about the issues regarding the drug, she said.

However, Jia said that people should not panic about the issues surrounding Avandia. She claimed that the dosage of the drug present in their country is lower than those present in drugs that are available in the Europe and the U.S. Furthermore, she explained that the doctors in their country only use the drug after carefully examining the medical history of the patients, unlike in the western countries where doctors prescribed the drug.

Currently, there were no reported cases of serious adverse effect with the use of the drug, said the Chinese official.