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Reglan - Side Effect Lawsuit Information

Reglan Introduction to Market

Millions of people in the United States suffer from gastrointestinal problems, and as a result of this reality, companies from all over the world have poured resources into the research and development of medications designed to treat the symptoms of the different gastrointestinal maladies.

One of the leading products that was brought to market in the United States in recent years that helped patients deal with gastrointestinal tract issues is known as Reglan, which is manufactured by Baxter Pharmaceuticals. Reglan sold very well for a time, but unfortunately it’s encountered serious problems of late. Below is a brief overview of the issues surrounding Reglan.

Reglan's Intended Use

Reglan was originally approved by the FDA in 1999 for sale in the United States, and since then it’s primarily been used to treat to gastrointestinal problems:

  • Diabetic gastroparesis – This is a condition where the patient with diabetes is unable to empty materials into the intestines quickly enough, leading to nausea, vomiting and loss of appetite.
  • Gastroesophageal reflux that leads to heartburn – A problematic reflux reaction is commonly known only as heartburn, and Reglan was most prominently used with patients who had tried other medications without success.
    • Arms
    • Legs
    • Trunk
    • Mouth
    • Tongue
    • Face

Harmful Side Effects Arise with Reglan Side Effects

For several years, Reglan seemed to enjoy a high level of success, as there were side effects reported in some patients, but they were few in number and did not prompt the FDA to get involved. However, recent reports have led to the FDA’s involvement, and that’s because of a troubling link between Reglan and a rare but serious side effect known as Tarvide Dyskinesia (TD). TD is a disease that attacks the central nervous system and leads to increasingly rapid and involuntary movements of different parts of the body, including:

As the rapidity of these movements increase, otherwise simple daily tasks such as eating and walking become nearly impossible. The worst aspect of this disease is that not only are scientists unsure of how it starts in the body, but at this time there is no cure, meaning that the patient must suffer through a lifetime of increasing struggles.

The FDA’s Reaction to Reglan

The FDA received these reports and acted swiftly and on two levels. The first remedy the FDA executed on Baxter Pharmaceuticals was to order a ‘Black Box’ warning on all labels of Reglan going forward. A black box label is the requirement of a clear and distinct warning on every container of a drug or product that warns consumers of the specific risks involved with using it. Secondly, the FDA ordered a ‘REMS’ study, which stands for risk evaluation and mitigation strategy. This basically means that a study must be performed that measures whether or not the risks of allowing Reglan to remain on the market outweigh the benefits. These represent the two most severe sanctions available to the FDA short of a recall.

You Need an Injury Oklahoma Reglan Attorney

If you or someone you love has been injured due to using Reglan, you need to take action. Privett Law today to schedule a free initial consultation.