New Orleans, LAIt has been almost a year since the public became aware of the link between Reglan and tardive dyskinesia. Many say they had no idea about the risks of permanent Reglan side effects. Now some parents are coming forward with concerns about the effect of Reglan on their children.
In February 2009 the US Food and Drug Administration issued a warning about the risk of serious side effects associated with Reglan. The FDA was specifically concerned with tardive dyskinesia, a movement disorder characterized by repetitive, uncontrollable movements, including grimacing, lip smacking, tongue protrusion and random facial movements. Tardive dyskinesia can also cause repetitive movements of the limbs and torso.
"Recently published analyses suggest that metoclopramide (Reglan) is the most common cause of drug-induced movement disorders," stated the FDA in a 2/26/09 news release. "Another analysis of study data by the FDA showed that about 20 percent of patients in that study who took metoclopramide took it for longer than three months."
Many patients were surprised to learn that they took Reglan for much longer than recommended. Some report having taken the medication for years.
Those who are especially susceptible to negative effects of Reglan include the elderly and people who took the drug for longer than three months, the FDA notes. However, the news release made no mention of children and infants.
Kathy P. wrote to LawyersandSettlements that both her son and her niece have taken Reglan for years—her niece has been taking Reglan for almost eight years. Kathy says that both children display symptoms of tardive dyskinesia, including a protruding tongue, uncontrollable body movements, blinking and constant lip licking.
There is no known treatment for tardive dyskinesia. Some patients who discontinued use of the medication say they have not experienced a lessening of their symptoms. With no treatment for tardive dyskinesia, it is possible that infants and children who develop the disorder could have it for the rest of their lives.
Lawsuits have been filed against the makers of brand-name and generic Reglan alleging that patients were not properly warned about the risk of tardive dyskinesia. These patients now suffer from the rare disorder because patients and doctors were unaware that Reglan should not be prescribed for longer than three months.
The FDA news release announced that Reglan would carry a black box warning alerting patients and doctors to the risk of tardive dyskinesia.
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