"The FDA issued a black box warning for Reglan [on February 26, 2009] that warns about the risks associated with a neurological disorder called tardive dyskinesia," Drake says. "The old label was inadequate. It downplayed the risks associated with tardive dyskinesia. It said one in 500 people may develop this neurological disorder. However, it's actually more prevalent than that. Potentially one in five patients could be affected by this."
Tardive dyskinesia is a neurological disorder characterized by facial tics and involuntary muscle movements, including grimacing, lip smacking, lip pursing, tongue protrusions, rapid eye blinking and movements of the arms, legs and torso.
Although Reglan is frequently prescribed for the treatment of gastroesophageal reflux disease (GERD), it is also prescribed off-label to help pregnant women with morning sickness and to increase milk supply in women who are breast-feeding. The new warning is not clear about how these women may be affected by Reglan side effects.
"There was a study done that seemed to indicate no risk of birth defects associated with Reglan," Drake says. "But the study did not go into the risks of tardive dyskinesia on the mother or the baby. The same is true of women who are breastfeeding. The label says that the drug passes through breast milk, but it has not been proven safe for the baby when the mother is given Reglan to increase her milk supply."
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Patients who have taken generic or brand name Reglan for an extended period and believe they have developed tardive dyskinesia should contact their doctor to discuss their options.
"If people were prescribed Reglan, they should talk to their doctors immediately, especially if they were taking it for a long time," Drake says. "The longer they took Reglan, the more prevalent the symptoms. Tardive dyskinesia can be mistaken for Parkinson's disease, even by medical professionals. Patients who think they were misdiagnosed should talk to their doctor and speak with an attorney."