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Is Zofran’s Warning Label Sufficient?

Warning on ZofranNowadays we are constantly being bombarded with commercials and radio advertisements that detail the horrors experienced by people who had taken medication without being informed of the potential side effects or who had been prescribed medication that was rushed to market without adequate research or clinical trials to support safe use. Zofran was marketed for decades as a treatment for nausea but the product labeling failed to warn of the possible effects that the medication could have on unborn children. Why was Zofran’s manufacturer allowed to market this drug without providing the relevant warnings and who should be responsible for making sure that all medications on the market come with accurate and unabridged warnings to ensure the safety of everyone who consumes them?

GlaxoSmithKline Knew More than it Led On

Zofran was created in the 1980s and its original purpose was treatment solely for patients who had undergone intense cancer treatments or were recovering from surgery. It was proven to alleviate the symptoms of vomiting and severe nausea in those to whom it was prescribed and received approval by the FDA in 1991. It did not receive approval for use by pregnant women or for the treatment of morning sickness, however, and GlaxoSmithKline never sought approval for this form of use either. Instead, the company knowingly circumvented the FDA by encouraging doctors to prescribe it off label.

The primary reason that GlaxoSmithKline chose not to seek FDA approval to market Zofran as a medication for the treatment of morning sickness is that its own research suggested that there was a potential that the medication could cause serious harm to the development of unborn children. The market of pregnant mothers experiencing severe nausea and vomited represented the opportunity for immense profit, however, and GlaxoSmithKline made the choice to conceal the information and place profits above the lives of the victims impacted and the families who would need to care for them.

How Drug Labeling is Overseen and Regulated

The Food and Drug Administration keeps records of complaints and known adverse events that are associated with medications and is able to take action for the benefit of our health when evidence suggests that a product is unsafe. It is a legal requirement that all drug manufacturers label their medications with warnings relevant to any severe or potentially fatal side effect. If such a warning is omitted and the FDA discovers a link between a medication and an adverse event or reaction, action may be taken depending on the severity of the infraction and the potential dangers to the health of patients taking the medication.

Pharmaceutical companies are not only encouraged to constantly update their drug warning information, but they are required to in the event a strong link to serious health concerns is established. If the manufacturer of a drug fails to provide adequate warnings, the FDA may step in and require such warnings. Many lawsuits involving pharmaceuticals are centered on whether sufficient warnings were present on labels and in most cases, the medications remain on the market with revised labels that inform patients of the current known side effects and risks.

Is Zofran’s Warning Label Sufficient

The short answer to this is a simple— no. It simply does not matter that Zofran was prescribed off label because if the medication is known to cause birth defects, the information must be presented to doctors prescribing the medication and to patients taking it so that medical professionals can make educated decisions and the patients have full disclosure. Incentives were even provided to doctors to write prescriptions for Zofran in the form of kickbacks, suggesting an even more insidious degradation of medical ethics in favor of profits on part of GlaxoSmithKline.

It is hard to believe that any doctor would prescribe a medication in good conscience with the knowledge that it could cause serious harm to an unborn child. Therefore, the erroneous assertions given to the medical community by GlaxoSmithKline that the medication was safe tarnished the reputations of numerous medical professionals and caused great suffering to an untold number of children who must now cope with medical conditions that they may never fully recover from.

If you were prescribed Zofran during your pregnancy and your child was born with congenital birth defects– such as cleft palate, developmental problems, neurological disorders or other injuries, contact the Rosenfeld Injury Lawyers LLC today to learn more about your rights and legal options. We will be happy to arrange a free consultation in order to collect all of the information needed to launch a deeply thorough investigation into your child’s injuries so that we can let you know whether you have a strong case and how best to pursue it. In addition, we will be glad to assist you in obtaining the best medical care available for your child so that he or she receives the treatment that he or she is entitled to while ensuring that you will be able to afford it.

Our attorneys only get paid when you do and if we fail to secure compensation on your behalf, our time and services will be without charge.