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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.
Lindsey C. Whitener was seven weeks pregnant with her second child when her physician prescribed Reglan (metoclopramide) to ease her nausea and vomiting from morning sickness. She took it for four weeks. A few months later, Whitener began having problems with her pregnancy and gave birth to her son prematurely at 36 weeks gestation. Her son, Lucas, was born with extensive physical disabilities and medical problems and spent the first six months of his life in the hospital. Doctors said they did not know the cause of Lucas’ birth defects.
Metoclopramide, known in the U.S. by the brand names Reglan and Metozolv, is a commonly prescribed medication used in the treatment of serious gastrointestional disorders, such as GERD and gastroparesis. Earlier this year, a study suggested that the medication may also help women suffering from morning sickness, in particular a severe form marked by serious vomiting called hyperemesis gravidarum. The study, which involved more than 80,000 births to Israeli women, found that women who took the medication while pregnant did not raise the risk of harming their unborn child.
A Canadian study of pregnant Israeli women who took the heartburn medicine Reglan (metoclopramide) to treat morning sickness has shown the drug does not increase the rate of birth defects in the babies born to those women, compared with babies born to women who did not take the medication.
While researchers are calling this encouraging news to pregnant women, the U.S. Food and Drug Administration (FDA) says more studies must be conducted before the agency will grant approval for the drug to be used in the treatment of morning sickness. After all, the drug carries a black box warning to consumers and health care providers of a serious, debilitating and often irreversible movement disorder called Tardive Dyskinesia. Other problems, it appears, may occur when the medication is taken on a long-term basis, even for pregnant women.
A medication commonly prescribed to treat heartburn and slow gastric emptying in people with diabetes is showing promising results in treating the symptoms of morning sickness in women in early pregnancy without risk of harming the unborn child, according to the Associated Press. However, the medication may carry risks for mothers if used long-term.
