News Tagged ‘black box warning

Metozolv label has new tardive dyskinesia warning

metozolv package e1291905637855 150x150 Metozolv label has new tardive dyskinesia warningThe new chewable heartburn medication , an orally disintegrating version of Reglan (metoclopramide), has added a warning to its label alerting users of a risk of the serious movement disorder Tardive Dyskinesia with long-term use of the drug. The change to the drug’s safety label was approved by the Food and Drug Administration (FDA) and announced this month.

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Heartburn drugs before pregnancy may increase risk for birth defects

Women who use heartburn medication during pregnancy should not be overly concerned about the drugs causing birth defects, but using the drugs before they become pregnant may cause problems for the unborn child, according to a new study from Denmark published in the New England Journal of Medicine.

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Restless leg syndrome turns out to be movement disorder caused by Reglan

PHOENIX, ARIZONA – Ron, a musician and artist, was having trouble sleeping. His legs would move involuntarily back and forth under the sheets. At first, both Ron and his doctors thought he suffered from restless leg syndrome. But after a battery of tests conducted by neurologists, and a review of his medical history and medications, doctors determined that Ron suffered from a Parkinson’s-like condition known as Tardive Dyskinesia. They say it was caused by the heartburn medication Reglan.

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Reglan as morning sickness treatment still carries risks for mom

A study into the safety of the anti- drug metoclopramide, also known as the brand name Reglan, on pregnant women indicates that the drug is safe in mothers and their unborn children, according to a first-time study of the drug’s affects on expectant mothers. The drug is not indicated for pregnant women but the drug has an off-label indication for the treatment of .

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Woman blames Reglan for causing her young child permanent disability

Metoclopramide2 150x150 Woman blames Reglan for causing her young child permanent disabilityDawn Harris says she was never made aware that long-term use of the acid reflux drug Reglan (metoclopramide) could cause her young child to suffer a serious, permanent and disabling neurological injury that results in involuntary movements of the face, arms and torso. The Louisiana mother has filed suit against the makers of the drug, claiming the medication caused her child to develop Tardive Dyskinesia.

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Reglan users blame depression, suicidal thoughts on heartburn drug

The prescription drug Reglan, also known by the generic metoclopramide, is taken by more than 2 million people to treat the symptoms of gastrointestinal problems such as severe heartburn, gastroesophageal reflux disease (GERD) and gastroparesis. Many people have become aware of the drug’s serious side effects, including the debilitating neurological disorder known as Tardive Dyskinesia in which the muscles move involuntarily. Reglan’s safety label now includes an FDA black box warning for the risk of the disorder. But another serious condition is being blamed on the medication – suicidal ideation.

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Long-term use of heartburn drug can cause serious movement disorder

Thousands of people who suffer from gastrointestinal problems such as severe heartburn, acid reflux and gastroparesis, are treated with the prescription drug Reglan, known by the generic metoclopramide. These drugs were originally prescribed for daily use for as long as two years in some patients. What patients may not realize is that long-term use of the drug is no longer recommended – and, in fact, falls under an FDA black box warning – as it can cause a serious and sometimes permanent neurological disorder known as Tardive Dyskinesia.

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Teenager finally finds relief from gastroparesis

Doctors said Gentrie Hansen’s uncontrollable bouts of and vomiting were caused by bulimia, the eating disorder in which victims force themselves to throw up food they eat to keep from gaining weight. But 14-year-old Gentrie knew better. “The worst part of my whole sickness was people telling you ‘you have an eating disorder’ and you know something else is wrong and you really want your food,” she told the Today show.

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Time is running out for victims of Reglan to file lawsuits

Time is running out for people who suspect they have experienced serious side effects from the heartburn drug Reglan (metoclopramide) to file a lawsuit seeking compensation for damages. The Food and Drug Administration (FDA) issued a black box warning on the drug on February 26, 2009. Most states have a two-year statute of limitations on personal injury and wrongful death lawsuits, which in the case of Reglan would begin when the black box warning was issued. The statute of limitations in other states ranges from one to six years.

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Doctor: woman’s ‘essential tremors’ caused by heartburn drug Reglan

Things were bad enough for Melissa.* She suffers from a gastrointestinal disorder that has compromised her lifestyle. But nothing prepared her for the problems she would have from the medication used to treat her condition. “I was just diagnosed with essential tremors from Reglan (metoclopramide),” she posted on the Inspire community billboard. “Great … another thing to deal with.”

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