Reglan - FDA Issues Black Box Warning
Reglan is a drug thats been used by people who have had gastrointestinal problems. Its been available via prescription, and its manufactured by Baxter Pharmaceuticals. The reason that Reglan has been in the news lately is because its alleged link to side effects has prompted the US Food and Drug Administration (FDA) to get involved with the regulation of this issue. At this point, Reglan remains on the market, but there have been steps taken to increase the warnings associated with it and an ongoing study meant to measure its risks versus its benefits.
Why is Reglan Used?
Reglan is used by people who tend to have two specific gastrointestinal problems more than others. These problems are:
- Gastroesophageal reflux that leads to heartburn Heartburn is an ongoing problem that leads most who suffer from it to use medications. Reglan has typically been the choice of those who have used other medications unsuccessfully.
- Diabetic gastroparesis Diabetics tend to suffer from the retardation of the process by which the gastrointestinal contents are emptied into the stomach. Reglan has tended to help with this process and mitigated the common symptoms which include nausea, vomiting and loss of appetite.
In a scientific sense, Reglan works by speeding up the contractions of the muscles contained in the upper gastrointestinal tract. This in turn leads to its contents being emptied into the intestines at a faster rate and thereby eliminating the symptoms associated with the two conditions described above.
Like all prescription drugs, Reglan had to obtain approval from the FDA before it could be marketed and sold in the United States. Reglan received that approval from the FDA in 1999, and the main ingredient in Reglan, metoclopramide, was approved by the FDA in 1985.
Side Effects of Reglan
Reglan has generated reports of side effects in the past that could be described as serious, but none were prevalent enough to prompt the FDA to get involved with regulating the drug. The side effect that did lead to the FDAs involvement is a rare condition known as Tardive Dyskinesia (TD). TD is a disorder thats permanent in nature, as there is no cure at this time. It features a series of rapid, uncontrollable movements of the following areas of the patients body:
- Abdominal region
The movements that result from the contraction of TD can be so rapid in nature that they can render daily tasks and processes that most take for granted all but impossible. For instance, if TD strikes the legs, the patient could have trouble walking. If it strikes the tongue, the patient may have a hard time communicating.
In relation to Reglan, one of the few tangible discoveries that has been made in regards to its relation to TD is that patients who have used Reglan for more than a period of between four and eight weeks have a much higher tendency to be at risk for the development of this disease. This conclusion is based on the data available from those who took Reglan and contracted TD.
There are medications in existence that can help to mitigate the symptoms of TD somewhat, but thats the best case scenario for anyone who contracts this disease. Additionally, TD is so unknown at this time that the medical science community has yet to discover the initial way in which TD manifests itself inside the body.
Prior to this recent issue, Reglan had been linked to several other side effects. Some of them could be and were serious, but none of them were prevalent enough in those who used the drug to warrant action by the FDA or any other governing body. These side effects included:
- Exacerbation of high blood pressure
- Neuroleptic Malignant Syndrome (NMS)
- Exacerbation of Parkinsons Disease
Like almost any drug, there were warnings regarding the mixing of Reglan with other types of medications. These medications included:
- Parkinsons Disease medications
- Sleep medications
- Monoamine oxidase inhibitors (MAOIs)
- Diabetes medications
- Seizure medications
What is a REMS study, and why is Reglan involved in one?
REMS is an acronym that stands for risk evaluation and mitigation strategy. A REMS is ordered by the FDA when its necessary to measure whether or not a drugs benefits outweigh its risks.
What is a Black Box warning?
A black box warning is another remedy used by the FDA, and is the second most severe remedy available short of a recall. Basically, it states that every container of a product that must include such a warning must clearly indicate on the label the risks involved with using said product.
What should I do if Ive been harmed by Reglan?
If you or someone you love has been harmed by Reglan, you need to evaluate your legal options. Contact the defective drugs lawyers at Phillips Law Group today to schedule a free initial consultation.