FDA Warns of Serious Side Effects For Reglan

On February 26, 2009 the Food and Drug Administration announced that manufacturers of metoclopramide, a drug used to treat gastrointestinal disorders, must add a black boxed warning about the risk of long-term or high-dose use. Reglan has recently been linked to tardive dyskinesia, a condition which may include involuntary and repetitive movements of the body, even after the drugs is no longer taken.  In June of 2009, it was ruled that Reglan lawsuits would not be consolidated into a Multidistrict litigation (MDL).

The various manufacturers of generic metoclopramide, which is still more commonly known by its brand name “Reglan”, have recently come under increasing fire as a result of their failure to warn that using the gastrointestinal drug for more than 12 weeks substantially increases the risk that users will suffer from tardive dyskinesia. It is important for a medical professional to adequately explain the increased risk of tardive dyskinesia induced by Reglan. It is also crucial that Reglan is only used for short-term relief of gastrointestinal problems when other treatments have failed, since the risk of developing serious Reglan side effects appears to increase with prolonged use. A medical professional’s failure to follow these precautions may constitute medical malpractice.

  The side effects associated with tardive dyskinesia, unfortunately, are typically permanent in patients, and depending on the level of damage incurred from Reglan use, may only subside slightly during the remainder of their lifetime.  High-risk groups include young individuals less than twenty years of age, as well pregnant women.  Additionally, persons suffering from depression should not take this drug, as there is an increased chance of suicide.  The patients typically exhibiting detriments from Reglan endured long-term treatment with the drug at higher dosages.  According to FDA research, patients taking the drug longer than three months developed tardive dyskinesia symptoms in over twenty percent of the cases reviewed. Victims suffering from severe Reglan side effects should consult a Reglan lawyer to ensure proper representation.