Nexium History and Background
AstraZeneca, a large, multinational pharmaceutical company, develops and distributes Nexium. Nexium was first approved in 2001 as an alternative method to treat heartburn. Unfortunately, this drug has also caused adverse side effects. If you or a loved one suffered harmful side-effects after taking Nexium, you might be entitled to compensation. Reach out to a lawyer who is knowledgeable about the Nexium history and background today. An experienced Nexium attorney could fight for you.
Nexium Approval Process
Before it was allowed on store shelves, Nexium needed FDA approval. Clinical researchers review the results from a clinical trial and note any adverse events and other issues that may have arisen, like if someone got sick, had a headache, or some other side-effect.
Clinical researchers are supposed to notate that so that all the information and data could be submitted to the FDA. The FDA then determines if the benefits outweigh the risks of a certain drug and if they are going to approve it or not. For drugs like this, there is no independent lab testing. The company that is seeking its approval is paying for funding, finding the study participants that actually take the drug, and collecting the data that is submitted to the FDA.
Nexium has been approved for heartburn or gastroenterology disease. It could also be used to treat erosive esophagitis, which is associated with GERD.
What Led to the Popularity of Nexium?
Several factors led to the popularity of Nexium and other similar drugs. The main reason is that the American diet is so poor. Instead of cleaning up their diet, some people would rather take a drug so they can continue eating what they want and not have to deal with the heartburn.
Another component is that heartburn is extremely common, regardless of what a person is eating or doing. Approximately 25 million adults experience heartburn on a daily basis. Heartburn is the most common symptom of GERD, and when people experience discomfort, they want to take a medication that is going to help them feel better.
Official FDA Warnings about Nexium
Warnings have been issued by the FDA regarding side effects and potential dangers of Nexium. As part of the approval process, oftentimes the company is required to submit adverse event reports and other information about a product’s side effect. For example, if a patient is taking Nexium for heartburn and they noticed that it is causing some different side effects, like headaches, fatigue, or nausea, the patient could go on the FDA’s website and fill out an adverse event report.
Most of the time when the FDA gets involved, they are responding to a number of adverse reports for the same symptom. For Nexium, there were many adverse event reports, mainly from doctors finding that patients who had been on Nexium or Prilosec were having long-term kidney damage, but had no other risk factors for that. For more information about the history and background of Nexium, consult with a knowledgeable lawyer.
How an Attorney Could Help
A lawyer could help hold the manufacturers of Nexium responsible for injuries that occurred prior to any FDA warnings. An experienced attorney could file suit against the various drug manufacturers, and, through the course of discovery, find out what the company knew, when they knew it, and whether they concealed any of the information it was a dangerous product. Call a lawyer today who understands the history and background of Nexium.