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GlaxoSmithKline Company Information

In 2001, Glaxo Welcome and SmithKline Beecham merged to form GlaxoSmithKline. Today, the manufacturer is divided into three major segments; pharmaceuticals, vaccines, and general health care. It has grown into one of the biggest vaccine producers in the world and proudly distributes 1.1 billion vaccinations to 173 countries. In recent years, one of its largest accomplishments was getting approval to produce the first lupus treatment in five decades.

The company stands by its motto of “enabling people to do more, feel better, and live longer.” However, as several of its products have been facing criticism for bringing dangerous risks to human health, the manufacturer has been under fire. Other marketing practice scandals have rocked the company as well.

Product Recalls from GlaxoSmithKline Company

Over the years, GSK has experienced a number of product recalls. Some of the latest involve Paxil, Alli, and its 2015 flu vaccine. On April 17, 2015, reports surfaced with information about a recall on the four-in-one flu vaccine because its effectiveness was found to decline over time. This meant many people who received the injection may not have been adequately protected from the flu virus.

One year ago, Paxil, GSK’s popular prescription antidepressant, was recalled as well. It was believed that its active ingredient was tainted. However, GSK ignored the potential problems until the FDA publicly issued a warning letter. Many questions were raised about the company’s integrity.

The company’s Alli weight loss pills were also recalled due to possible tampering. Many Alli vials were found on store shelves without labels and with fake tamper-resistant seals. Besides the bottles, pills were found in different shapes and colors.

Lawsuits Facing GlaxoSmithKline

Many lawsuits have been filed against GSK. Two of the most serious cases involve Paxil and Avandia. Paxil is used to treat depression, and Avandia is meant to help people with type 2 diabetes. From the time of FDA approval, Paxil has been shown to bring serious side effects. In 2004, the FDA noticed a heightened risk of developing suicidal tendencies in children or teens who took the medicine. One year later, further research revealed Paxil could cause pregnant women to give birth to babies with severe defects. Many consumers felt GSK did not adequately warn about these risks, so numerous lawsuits were filed.

Avandia is meant to treat type 2 diabetes, but it brings side effects that cause potentially fatal heart complications. The FDA uncovered Avandia may have been responsible for over 100,000 heart attacks. Clinical trials performed by the manufacturer showed taking this drug doubled the risks of cardiovascular problems in patients. However, its black-box warning label failed to include any mention of these side effects. In 2007, GSK was forced by the FDA to make changes in its labeling and highlight the possibilities of cardiovascular problems or death. Lawsuits against GSK’s Avandia allege the company knew about the dangers of this drug and ignored concerns of doctors. The manufacturer was responsible for warning the public about the raised cardiac risks but did nothing. It placed profits ahead of safety.

Verdicts Against GlaxoSmithKline Company

GSK agreed to pay $229 million to settle the initial lawsuits against its drug Avandia. However, no admission of guilt was given. Along with this settlement, it was reported that GSK set aside $6.4 billion in anticipation for more lawsuits. Besides claims against negative side effects, the manufacturer paid $3 billion and plead guilty to criminal charges for fraud. The verdict was based on implications that GSK marketed products for unapproved uses and failed to turn over safety data concerning Avandia. It was the largest fraud settlement in U.S. history.

Other verdicts hitting GSK in the pocket involve its drug Paxil. During one of the first court cases concerning this medicine, a GSK memo was released stating the company planned to “bury” negative results stemming from animal studies. In 1980, rat studies were performed and showed a link between Paxil and birth defects. No warning was issued to the public. By 1998, a large number of defects were reported. Clear GSK negligence was demonstrated, and juries sided with innocent victims. By 2012, this pharmaceutical giant paid more than $1 billion to settle over 800 claims.

Other GlaxoSmithKline Company Scandals

As GSK has marketed new items, certain safety concerns have surfaced about some of its products. In 2010, this company was found guilty of selling contaminated products made in one of its Puerto Rican plants. Paxil, Avandia, and certain baby oils were manufactured at this facility. Although it was responsible for over $5 billion in sales, it was closed in 2009.

In July 2012, another scandal hit the company. It faced charges of promoting drug uses not approved by the FDA. For example, GSK marketed Paxil to adolescents, but it was only approved for adult use. Wellbutrin, a drug approved to treat depression, was pushed as a prescription to overcome weight gain, sexual dysfunction, and ADHD. It was also uncovered that GSK bribed doctors to promote Avandia, a drug known to cause heart problems.

FDA Sanctions Against GlaxoSmithKline Company

After receiving numerous complaints of adverse side effects, the FDA announced it would restrict the use of Avandia. Only individuals who cannot control type 2 diabetes with other medications are allowed to use this drug. This action was deemed the best and safest way to protect the public.

During the 2014 recall of Paxil, the FDA posted a warning letter blasting a GSK plant in Ireland. An inspection uncovered the drug maker was releasing products that contained contaminants from a waste tank. Besides obvious unsanitary conditions, the FDA was concerned the flow of pharmaceutical waste into its products did not raise red flags with the quality control of GSK.

Besides paying large settlements in civil cases for many of its drugs, GlaxoSmithKline was forced into a five-year Corporate Integrity Agreement with the Inspector General. GSK was required to make massive changes to its business practices, including the way its sale force gets compensated. Instead of being awarded for reaching sales quotas, salesmen are currently paid on quality of service.

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