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Reglan:
Side Effects And Problems Of Reglan

Reglan Drug:
Reglan - FDA Issues A Black Box Warning

Reglan Lawsuits:
Reglan Lawsuits And Injury Claims

Reglan Lawsuits

If you or a loved one has been injured by taking the drug Reglan, the time is right to contact one of Macey & Searns experienced attorneys to find out how you can file a mass tort lawsuit and receive the monetary compensation that you deserve. Please continue reading to learn more about Reglan and the life-altering side effects associated with this drug.

FDA Issues ‘Black Box Warning’ to Reglan

On February, 26, 2009, the U.S. Food and Drug Administration (FDA) announced that Baxter Healthcare Corporation, the maker of Reglan, must add a ‘black box warning’ to their drug labels warning of the risk of the drug’s long-term and/or high-dose use. This ‘black box warning’ is the FDA’s strongest warning apparatus and sends up a flag to both potential and current patients as well as physicians. Reglan, generic name metoclopramide, is marketed by Baxter under Reglan Tablets, Reglan Oral Disintegrating Tablets, Reglan Injection and Metoclopramide Oral Solution. Other manufacturers of the generic drug, which also must add the ‘black box warning’, are Wyeth, Pliva, Schwarz Pharma and Teva Pharmaceuticals.

While there have been many serious side effects associated with Reglan and its generic equivalent, metoclopramide, perhaps the most widespread and devastating is tardive dyskinesia. This devastating syndrome presents with involuntary and repetitive movements of the body, including rapid eye movements and blinking, puckering and pursing of the lips, grimacing, lip smacking, tongue protrusion and impaired movement of the fingers. These symptoms usually continue even after Reglan has been discontinued, although symptoms may somewhat lessen. The elderly population is especially at risk for developing this demoralizing and socially disabling syndrome.

Other serious side effects include depression, hypertension (high blood pressure), Parkinson’s disease, dystonia (a neurological movement disorder in which sustained muscle contractions cause twisting and repetitive movements or abnormal postures, more often seen in children and young adults, persistent vomiting, fatigue, renal insufficiency and elevated prolactin levels that should limit use in patients previously diagnosed with breast cancer. Metroclopramide is counterindicated during the first trimester of pregnancies and should only be used in extreme cases in lactating patients.

Lawsuits Against the Manufacturers of Reglan

Lawsuits against Baxter Healthcare Corporation and the makers of the generic drug metoclopramide, stem from the maker’s failure to warn users and doctors about the risk of serious side effects. These suits allege that manufacturers grossly underestimated the risk of tardive dyskinesia when taking Reglan for more than four to twelve weeks. Some sources state that manufacturers of Reglan said that the incidence of tardive dyskinesia when using the drug was only about 0.2%, when the actual rate may be up to 100 times higher.

Some Reglan lawsuits claim that manufacturers failed to investigate the accuracy of Reglan’s label after safety had become an issue, that they did not monitor relevant scientific information related to the drug, that they failed to conduct post-market safety surveillance and that they were aware that the potential risks of Reglan far outweigh the benefits.

Manufacturers of metoclopramide are being required to implement a risk evaluation and mitigation (REM) strategy to ensure that potential and current users of the drug are receiving proper information regarding the tardive dyskinesia problems.

Reglan Usage

Although metoclopramide is only approved for the short-term use (four to twelve weeks) for the treatment of GERD (gastroesophogeal reflux disease), diabetes gastroparesis and delayed gastric emptying and severe nausea and vomiting associated with chemotherapy, perhaps as many as 30% of prescriptions are written for over the twelve-week approved duration, with some up to one year.

According to one physician in the Chicago-area, some patients are persistent in asking for prescriptions for Reglan because they get relief for their gastrointestinal problems not afforded by other medications. When advised as to the possible severe side effects, some patients state that they are getting such positive results from Reglan, they will risk any side effects. This doctor had actually lost patients when he refused to prescribe the medicine for more than the approved dosage period.

If you or a family member has been negatively affected by Reglan, contact us now by filling out the form on this page. Our experienced attorneys will help you get the compensation that YOU deserve.