BEACON TRANSCRIPT – Many pregnant women struggle with morning sickness and an apparent solution may be offered by a special drug, the only medication of this type approved by the Food and Drug Administration. However, a recent study found that there is no vital information regarding this drug.
Almost 75 percent of pregnant women suffer from morning sickness during the first months of the pregnancy. But at the same time, 1 percent of them experience a severe form called hyperemesis gravidarum. In these cases, doctors prescribe vitamins and sometimes medication. The only medicine for this approved by the FDA is Diclegis, a Canadian drug, but new studies now question the efficacy of the drug.
The first morning sickness medicine, Bendectin, was designed in the 1950s. It contained a combination of pyridoxine and doxylamine. Twenty years later, there appeared a number of lawsuits which claimed the morning sickness drugs was causing birth defects. After thirteen years, the drug was withdrawn from the market and the company suffered massive losses and huge legal costs.
However, an associate scientist and physician at St. Michael’s Hospital in Toronto, Dr. Nav Persaud, claims that the company selling Diclegis, Duchesnay, put the same mixture of active ingredients in the drug after Bendectin was withdrawn from market and only changed its name. Then, the FDA approved the drug in 2013.
Dr. Persaud makes a worthy claim by asserting that vital information regarding the harmful side effects of the drug is missing, but the FDA stand by their decision and, together with many other health specialists, they deem that the morning sickness drug is efficient.
The team of researchers managed to obtain information on the drug from the FDA but, from about 36,000 pages only 7,000 were related to the drug. Also, roughly 200 pages of a 359 pages long Health Canada document had been revised.
One last compelling argument is made up by the fact that nearly 31 percent of the women involved in a research on Bendectin did not complete the trial until the end. This is important, since vital information could have been extracted from the missing data. Moreover, the final results of the study were not even present.
Morning sickness drugs may seem like a blessing for women suffering from acute symptoms, but they may also put the mother and the baby’s health in danger.
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