Metoclopramide is a damaging drug that many doctors use to treat gastroesophageal reflux disease (GERD), a chronic form of heartburn. Some doctors also prescribe Reglan for nausea and vomiting.
Reglan was developed by Wyeth, the successor in interest to A. H. Robbins which first obtained FDA approval for the drug. Schwarz Pharma purchased from Wyeth the rights and liabilities associated with Reglan. Under FDA regulations Wyeth and Schwarz are the reference listed drug companies and the new drug application holders for Reglan.
Laws across the U.S. encourage prescriptions to be filled using generic products. The manufacturers of generic drugs routinely republish the package insert for the name brand prescription and both Wyeth and Schwarz were aware of this common practice, yet neither warned physicians, the general public or generic manufacturers of studies which showed that long term use of Reglan was harmful.
Reglan helps the stomach empty its contentsinto the intestines more quickly, and that sometimes reduces the symptoms of GERD. And while GERD may be a health problem, Reglan is an example of a cure that’s much worse than the original problem.
Reglan has recently received a Black Box warning from the FDA. The Black Box is the last step before a complete ban, and it means that doctors should prescribe the drug with the label very cautiously because it has a history of causing serious personal injury and wrongful deaths.
For many people who take Reglan, the Black Box has come too late and the drug has turned life into a personal injury nightmare of unending and unwanted movement. Numerous studies have conclusively linked Reglan with Tardive Dyskinesia, a debilitating condition
•a debilitating condition that causes
•loss of muscle control
•rapid eye blinking
involuntary movement of arms, fingers and legs
loss of abdominal muscle tone and control
Older individuals, especially women, suffer the most casesof Tardive Dyskinesia. One report found that drug-induced Tardive Dyskinesia has developed in 73,000 older adults, but it can strike anyone, including infants, who uses neuroleptics.
Tardive Dyskinesia is a condition that never happens by chance. It is an entirely iatrogenicdisease, meaning that it is “caused by doctors”. The most common culprit in cases of Tardive Dyskinesia is a group of drugs called neuroleptics, which are also used heavily in psychiatry.
Reglan is one of those neuroleptics, and researchers have been aware of their dangers for more than 25 years. In 1984, a Swedish doctor named Lars Martensson raised questions about their safety and wrote a paper that asked Should Neuroleptic Drugs Be Banned? In the paper he presented many observations which he had drawn from his own extensive research on Reglan and other neuroleptics. Three of the most important were:
• Brain damage from neuroleptics is serious and certain.
• Temporary use of neuroleptic drugs is a trap.
• After a few years patients in drug-free programs are better by all criteria.
A report in the Archives of Internal Medicinein 1989 concluded that “To prevent persistent and disabling movement disorders, long-term use of metoclopramide should be avoided, and patients should be carefully observed for potential neurologic reactions.”
A report entitled Metoclopramide, an Increasingly Recognized Cause of Tardive Dyskinesia, from the Parkinson’s Disease and Movement Disorders Clinic at Baylor College of Medicine in Houston, cited studies done there between 1981 and 2006. One crucial finding was that between 2000 and 2006, metoclopramide accounted for 34.5% of all cases of Tardive Dyskinesia. Haloperidol, the second worst offender, caused 24.4% of the cases.
In 2001, Dr. Peter Breggin, a highly respected psychiatrist in Ithaca, New York, testified against drugs such as Reglan in trial settled in favor of a plaintiff who had contracted Tardive Dyskensia.
And Tardive Dyskinesia, while the major personal injury caused by Reglan, the list of side effects is long and includes both body and mind.
Dr. Martensson, Dr. Breggin, and many others have spoken about the personal injuries that Reglan causes since the 1980s, but only in 2009 did the FDA given the drug its Black Box label. When we realize just how closely connected the FDA and the drug companies are, it’s surprising that any drugs ever get the Black Box.
If Reglan has has caused personal injury to you or a loved one, contact me immediately to find out if legal action against Baxter Healthcare or against Wyeth, which developed Reglan, can compensate you for your suffering.
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