› $150,000,000 verdict in personal injury case
Prokinetic drugs, such as Reglan (metoclopramide) are those that increase the movement of ingested material through the gastrointestingal tract. They are usually prescribed to treat diabetic gastroparesis, heartburn and nausea and vomiting in chemotherapy patients. Unfortunately, some prokinetic drugs may produce a number of serious side effects.
A Canadian study of pregnant Israeli women who took the heartburn medicine Reglan (metoclopramide) to treat morning sickness has shown the drug does not increase the rate of birth defects in the babies born to those women, compared with babies born to women who did not take the medication.
While researchers are calling this encouraging news to pregnant women, the U.S. Food and Drug Administration (FDA) says more studies must be conducted before the agency will grant approval for the drug to be used in the treatment of morning sickness. After all, the drug carries a black box warning to consumers and health care providers of a serious, debilitating and often irreversible movement disorder called Tardive Dyskinesia. Other problems, it appears, may occur when the medication is taken on a long-term basis, even for pregnant women.
The Food and Drug Administration (FDA) has accepted the complete response from Salix Pharmaceuticals for its orally disintegrating tablet (ORT) form of metoclopramide called Metozolv, and says it has granted a Prescription Drug User Fee Act (PDUFA), which authorizes the FDA to collect fees from companies that produce certain human drug and biological products, for September 11, 2009. Salix is seeking approval for its drug in the treatment of short-term therapy (4-12 weeks) for adults with symptomatic, documented gastroesophageal refulx (GERD or heartburn) who fail to respond to conventional therapy, and for the relief of symptoms associated with acute and recurrent diabetic gastroparesis (delayed emptying of the stomach).
Are little Jessica’s sudden head jerks a side effect of the heartburn drug Reglan? It’s a question posed along with a video of the toddler by Fiestagrill on YouTube.
Reglan, also known as metoclopramide, is generally prescribed to treat diabetic gastroparesis in adults and gastroesophafeal reflux in adults and children. Recent clinical studies have shown that it is safe for the treatment of morning sickness in women who are pregnant. However, a recent FDA warning has made people like Fiestagrill question whether the medication is causing serious injury to babies as well as children.
Questcor Pharmaceuticals Inc. has just released the study results of its Phase II clinical trial on a metoclopramide nasal spray for the treatment of diabetic gastroparesis, a condition in which contents remain in the stomach for a longer period of time than normal. Left untreated, gastroparesis can lead to fluctuations in blood glucose, general malnutrition, intestinal obstruction and bacterial infection.
