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Doctors Still Able To Prescribe Zofran For Morning Sickness

Even with hundreds of lawsuits pending around the country, Zofran's approved use for anti-nausea allows doctors to prescribe the drug off-label for morning sickness if they so choose.

Wednesday, December 2, 2015 - Even with more than 100 lawsuits currently pending in multidistrict litigation with hundreds more likely on the way related to GlaxoSmithKline's (GSK) anti-nausea drug Zofran and its alleged connections to birth defects, doctors nationwide are still able to prescribe the drug to pregnant women off-label. This gets to the crux of the issue with many of the lawsuits, which is that many doctors that have been prescribing the drug off-label to pregnant mothers have done so with the encouragement of GSK even though it never passed the proper standards with the FDA to be able to be employed for that purpose.

Zofran can still be prescribed for its original purpose, which was to help with nausea issues stemming from procedures such as chemotherapy and following surgeries. This also allows doctors, however, to prescribe that legal drug for uses it was not approved for, such as treating morning sickness in women. These off-label marketing techniques have been employed by GSK in the past, and unfortunately are a large profit-driving force for pharmaceutical manufacturers as they can sell more medications if they are able to convince doctors of their potential benefits outside of FDA approval.

GSK has been the focus of off-label marketing claims in the past, paying $3 billion in 2012 to settle a series of charges and lawsuits brought by the U.S. Department of Justice over a number of infractions in addition to the off-label allegations. The practice is used by pharmaceutical companies to help drum up profits for a drug that might not pass the necessary checkpoints to be approved by the FDA to treat a desired symptom. Plaintiffs are claiming that GSK was aware of the possibility of Zofran not making through the testing process because of the drug's link to birth defects and instead chose to market the drug to treat morning sickness to doctors off-label.

The medication is one of the strongest options for anti-nausea treatments, and for this quality was targeted for use to treat morning sickness symptoms. Unfortunately, more Zofran research is pointing to the existence of a link between the drug and an increased risk of birth defects. The dual use of the drug is where the FDA usually comes in, with testing standards marking the difference between what is safe to prescribe and what either is not safe or requires further study. Off-label marketing bypasses this process.

The variance in the severity of birth defects is found throughout the Zofran birth defect lawsuits, as additional claims of kidney, lung and brain defects have also been alleged in addition to the instances detailed above. All plaintiffs in the lawsuits have claimed that drug manufacturer GlaxoSmithKline intentionally marketed Zofran off-label to physicians with the intention of having it prescribed to women suffering from morning sickness symptoms. There have been a number of Zofran birth defect research studies detailing links between the drug and birth defects, and these have been presented by attorneys for Zofran claimants in the early stages of litigation that have been underway for months.

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Onder, Shelton, O'Leary & Peterson, LLC is a St. Louis personal injury law firm handling serious injury and death claims across the country. Its mission is the pursuit of justice, no matter how complex the case or strenuous the effort. Onder, Shelton, O'Leary & Peterson has represented clients throughout the United States in pharmaceutical and medical device litigation such as Pradaxa, Lexapro and Yasmin/Yaz, where the firm's attorneys held significant leadership roles in the litigation, as well as Actos, DePuy, Risperdal and others, and other law firms throughout the nation often seek its experience and expertise on complex litigation.