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GlaxoSmithKline Settles for $41 Million in Paxil Manufacturing Case

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New York, NYGlaxoSmithKline has reportedly decided to settle allegations over manufacturing processes for drugs such as Paxil and will pay $41 million to various states across the US, reports Reuters.

According to the news source, the drug company will pay portions of the settlement to 37 states across the country as well as Washington, DC. The settlement reportedly stems from accusations over questionable manufacturing processes at the company's former Puerto Rico factory.

In a statement, the drugmaker said that while it did not admit to any wrongdoing or liability, it decided to settle the case in order to avoid further litigation.

"The company chose to settle the matter, which it initially disclosed in its 2010 fourth-quarter results and its 2010 annual report, to avoid the expense and uncertainty of protracted litigation and trial," read the statement.

The attorneys general making the allegations against GlaxoSmithKline claimed that the drug company committed deceptive practices when it distributed some lots of certain medications, which were scrutinized for sub-par manufacturing techniques from 2001 to 2004, according to the news provider.

The drugs were reportedly produced at the Cidra, Puerto Rico factory, which ceased operations in 2009.

Among the medications included in the legal action taken by the Justice Department were antinausea drug Kytril, diabetes drug Avandamet, antibiotic Bactroban and Paxil CR, an antidepressant.

According to the National Center for Biotechnology Information (NCBI), Paxil is prescribed in order to treat conditions such as depression, panic disorder and social anxiety disorder. The tablet, which is taken by mouth, is typically consumed once per day.

In addition to typical side effects such as headache, dizziness, stomach pain and heartburn, Paxil has also been associated with birth defects such as persistent pulmonary hypertension of the newborn (PPHN).

This condition is a "cardiopulmonary disorder characterized by systemic arterial hypoxemia secondary to elevated pulmonary vascular resistance with resultant shunting of pulmonary blood flow to the systemic circulation," according to the University of Washington's Academic Medical Center.

The US Food and Drug Administration has previously warned that antidepressants like Paxil—when taken by pregnant women after 20 weeks' gestation—can cause a six-fold increase in the number of babies born with the condition.

Additionally, the FDA says that combining drugs like Paxil with triptan medications can potentially lead to the development of life-threatening serotonin syndrome.


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