Gastrointestinal Medications Come Under FDA Scrutiny

Gastrointestinal disorders affect countless people around the world, and these problems can arise in several different ways.  Unfortunately, there is no real ‘cure’ for many of these disorders, but that hasn’t stopped companies all over the world from putting time, money and resources into the development of medications that will at least mitigate the problems associated with gastrointestinal conditions.

Key Ingredient

Although many different brand names have hit the market in recent years that are intended to help manage these problems, there appears to be one ingredient above others that is used in these products – metoclopramide.  Metoclopramide is a substance that helps to speed the movement of a patient’s stomach muscles, thereby shortening the time in which it takes for the stomach contents to empty into the intestines.  Unfortunately, it also appears that metoclopramide is the ingredient that’s been linked to the development of serious problems in those who have used these substances.

Problems Arise

Recent reports have come about that highlight a potential link between patients who use these products and the development of a condition known as tardive dyskinesia.  This condition is one that features the following common symptoms, according to a public health warning recently issued by the FDA:

  • Involuntary/ repetitive movements of the extremities
  • Lip smacking, pursing and puckering
  • Grimacing
  • Tongue protrusion
  • Rapid eye movements or blinking
  • Impaired movement of the fingers.

Unfortunately, these symptoms are rarely reversible and there is no accepted treatment for them at this time.

The FDA’s Actions

When a substance draws unwanted attention in cases such as this one, the FDA has a few remedies available.  At this point, two have been executed.  The first is the requirement of a ‘black box warning’ that’s to be affixed to all products containing metoclopramide that must detail the risk described above.  The second remedy is the requirement that a risk evaluation and mitigation strategy, or REMS, be done.  The REMS is designed to weigh the risks vs. the reward of using this product and to provide additional warning to users of these products.

The Brand Names

The FDA listed several brand names of metoclopramide-containing products, and they include:

  • Reglan Tablets
  • Reglan Oral Disintegrating Tablets
  • Reglan Injection
  • Metoclopramide Oral Solution

Your Next Step

If you or anyone you love has been harmed as a result of using any of these products or any others containing metoclopramide, you need to contact a defective products attorney as soon as possible to schedule a free initial consultation. 


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