› $150,000,000 verdict in personal injury case
The new chewable heartburn medication Metozolv, 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.
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.
A study into the safety of the anti-nausea 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 morning sickness.
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.
Doctors said Gentrie Hansen’s uncontrollable bouts of nausea 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.
Diabetics who suffer from nausea, vomiting, bloating, or abdominal discomfort after eating may be eligible to participate in a study for an investigational medication to reduce the symptoms associated with delayed stomach emptying, also known as gastroparesis, a condition many diabetics experience.
Wendy from Oklahoma sought advice from fellow gastroparesis sufferers on Inspire.com’s group forum after her doctor recommended she take Reglan (metoclopramide) to treat symptoms of her condition. Gastropareses causes pain and nausea from slow emptying of the stomach contents. Wendy was concerned, she said, because “I read (Reglan) was the leading prescription cause for tardive dyskinesia,” a debilitating involuntary movement disorder similar to Parkinson’s.
An estimated 250,000 to 400,000 people in the United States have Tardive Dyskinesia, a disfiguring and debilitating involuntary movement disorder involving symptoms such as lip smacking, tongue thrusting and protruding, eye blinking and bulging, head jerking, facial grimacing, and puckering and pulsing of the lips. The muscle spasms can become painful and embarrassing and often are permanent. But what is most disturbing is that in many cases, the condition could have been prevented.
You can’t turn on the TV these days without hearing that the heartburn medication Reglan, also known by the generic name metoclopramide, has been linked to the serious involuntary movement disorder, Tardive Dyskinesia. But the drug also carries another serious warning – it can cause depression and suicidal thoughts.
Tranzyme Pharama says its new treatment for diabetic gastroparesis, a disabling disorder in which the stomach takes too long to empty its contents, has shown positive results in phase II clinical trials among diabetic patients with the digestive disorder. The pharmaceutical company was granted “fast-track status” by the Food and Drug Administration (FDA) for TZP-102, a designation that is typically reserved for drugs that treat serious and unmet medical needs. The designation is designed to speed up the review and approval process.
