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Attorney Concerned about Reglan Side Effects in Infants

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Los Angeles, CAFor adults who have suffered Reglan side effects, including tardive dyskinesia, the prospect of suffering from involuntary movement for the rest of their lives can be daunting. For children, the outlook is even more troubling—simply because not much is known about the risk of Reglan side effects in infants, says Roger Drake, an attorney with Baum, Hedlund, Aristei & Goldman.

"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."

Drake says no studies have been conducted to examine the risk of tardive dyskinesia in babies whose mothers take Reglan, even though the drug manufacturers know that Reglan is used in such circumstances.

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."

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READER COMMENTS

Posted by

on
I was given Reglan IV while inpatient in the hospital for hyperemesis. I took it orally at home for the same reason prescribed by my OBGYN. I had horrible headaches when given Reglan IV and headaches not as bad when taken orally. My daughter was born premature. I don't know what all medications she was given during that time through all of those tubes. She was later diagnosed with ADHD. I have read too many stories of women given Reglan while pregnant and their babies being born premature and their children being diagnosed with ADHD for it to be coincidence. Is there more information or has there been lawsuits for this? I hate that my child may be suffering through ADHD because of me being given Reglan for nausea and vomiting. Why did doctors stop giving phenergan for hyperemesis? That's what I was given in my earlier pregnancies and it worked quite well(unlike Reglan )and didn't harm my children.

Posted by

on
My Grandaughter took reglan for over a year,since she was born.She is now a little over 4 years of age and cannot talk can this be from the drug reglan,she has been tested for several test and hearing is fine, and doctors cannot find anything wrong, she goes to pre-kindergarten and is very smart understands and follows directions trys to talk but just can not none of her words are clear

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