Reglan is a drug that’s used primarily to help people deal with gastrointestinal problems, and it’s manufactured by Baxter Pharmaceuticals. Reglan is only available via prescription, and the drug has been under scrutiny lately from such entities as the US Food and Drug Administration (FDA), and it’s currently under review in terms of whether or not its benefits outweigh its risks when deciding whether or not it will remain on the market in the United States.
Reglan is used primarily to treat and help with two common gastrointestinal problems:
- Heartburn that is caused by gastroesophageal reflux – Reglan is especially prevalent in those who have tried other medications without success.
- Diabetic gastroparesis – This is a condition where people with diabetes deal with a slow process whereby the stomach’s contents empty into the intestines. It is associated with symptoms of nausea, vomiting and a lack of an appetite.
Reglan works by speeding up the rate at which the muscles in the upper digestive tract contract, thereby creating a process where its contents move into the intestinal tract at a faster rate.
The FDA approval process for Reglan can actually be traced back to 1985, when metoclopramide, the main active ingredient in Reglan, was approved by the FDA for medications as an active substance. Reglan was individually approved by the FDA for sale in the United States in 1999, and as is the case with any drug’s approval, it was obtained based on the results of studies performed in controlled environments.
The side effects that have been linked to Reglan are the reason that the drug and Baxter Pharmaceuticals are in their current position, as there were reports generated that prompted the FDA to take immediate action. However, there were some side effects associated with Reglan in the past that were not seen as common enough to warrant governmental involvement, and they included:
- Worsening of high blood pressure
- Neuroleptic Malignant Syndrome (NMS)
- Worsening of Parkinson’s Disease
The side effect that reached a level of prevalence that prompted the government to act was a rare condition known as Tardive Dyskinesia (TD). TD is a condition that is largely unknown at this point. Specifically, this means that scientists are still debating theories as to how it originally forms in the body and advances, and at this time there is no cure available for TD.
Symptoms of TD include a series of rapid, sometimes continuous movements of the following areas of the body:
- Mouth and face
These movements can become so severe and rapid in nature that basic daily functions of life become difficult if not impossible. For instance, if the legs are affected by TD to a severe enough degree, patients can lose the ability to walk on a regular basis. There are medications available that will mitigate the symptoms, but anyone who contracts TD faces a lifetime of stress, struggle and extreme difficulties.
Of the limited discoveries made in relation to Reglan, one that stands out is that those who take these medications for any period of time longer than a few weeks tend to greatly increase the risks involved with the side effects associated with Reglan.
While there was no definitive action by the FDA in relation to Reglan until recently, there were reports of some side effects with the drug. However, this is common among a majority of medications that hit the market. These side effects included:
- Exacerbation of Parkinson’s Disease
- Neuroleptic Malignant Syndrome (NMS)
- Exacerbation of high blood pressure
While some of these side effects were dangerous, they were not prevalent enough to warrant official action.
Reglan is a specialized drug, which means that there have been instances of contraindications in the past. Some of these types of medications include:
- Sleep medications
- Monoamine oxidase inhibitors (MAOIs)
- Parkinson’s Disease medications
- Diabetes medications
- Seizure medications
What prompted action by the FDA against Reglan?
The FDA acts on a reactionary basis after a drug is approved. This means that if enough reports are generated that detail a link between a medication and serious side effects, the FDA will study the issue and act accordingly.
Why did the FDA require a ‘REMS’ study?
A REMS study is a study that is meant to define if a medication’s risks are worth keeping it on the market based on the benefits it provides. A REMS can lead ultimately to a recall, but that is not always the case.
Can I file a lawsuit if I have suffered damages from taking Reglan?
Possibly. While all medications have certain, anticipated side effects, a drug manufacturer has a duty to inform physicians adequately regarding the known risks associated with its drugs. If a manufacturer fails to do so, it can be held responsible to patients who are injured as the result of inadequate warnings, under a legal theory known as “product liability.” Depending upon the particular circumstances of your case, damages may include recovery for any of the following:
- Past and future medical expenses
- Past and future pain and suffering
- Lost wages
- Loss of future earning capacity
- Emotional distress
If you or a loved one has experienced any health problems while taking Reglan, you should contact your doctor immediately. You may also wish to contact an experienced Reglan lawyer to discuss your legal options. As all legal claims are subject to time limits, however, you may risk forfeiture of your right to financial compensation if you delay.