Do Reglan Risks outweigh Benefits for Morning Sickness?
June 11th, 2009. By admin
There were 113,612 singleton births during the study period. A total of 81,703 of the infants (71.9%) were born to women registered in Clalit Health Services; 3458 of them (4.2%) were exposed to metoclopramide during the first trimester of pregnancy. Exposure to metoclopramide, as compared with no exposure to the drug, was not associated with significantly increased risks of major congenital malformations (5.3% and 4.9%, respectively).
Given that Reglan—which is typically prescribed for acid reflux (GERD)—was given a black box warning by the FDA earlier in the year for its connection to Tardive Dyskinesia (characterized by involuntary, repetitive movements of the extremities, lip smacking, grimacing, tongue protrusion, rapid eye movements or blinking, puckering, pursing of the lips, or impaired movement of the fingers), it’s hard to imagine taking such a drug while pregnant.
So it will be interesting to see what, if anything, the FDA will do based on the results of this latest study. For now, Reglan remains classified by the FDA as a Pregnancy Category B drug-meaning they don’t have enough information to determine if it does cause problems.
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