An estimated 35 million women have taken Diclegis over a span of more than 40 years. Recently, the Food and Drug Administration cracked down on the morning sickness pill.
In a recent publication of PLOS One, it was noted by researchers that an older version of the drug existed in the 1950s. For the current study, data was reviewed by researchers and found that there is little evidence of the medicine's effectiveness in treating nausea.
According to Dr. Navindra Persaud, a researcher at St. Michael's Hospital and the University of Toronto and the co-author of the study, the medicine is the first-line treatment for nausea and vomiting during pregnancy.
Dr. Persaud went on to state that they had now more information pertaining to the study done in the 1970s and questions whether the morning sickness pill should have been approved and whether it is effective.
According to the research, the trial in 1970 was designed to see if the drug was effective during the first trimester of pregnancy.
Dr. Persaud and Dr. Rujun Zhang from the University of Toronto studied 36,000 pages of the original study from the Food and Drug Administration that includes the original study report, protocol and summary results. Also, included in the research were documents from Health Canada as reported in Fox News.
The original clinical trial was held at Merrell-National Laboratories, which is now defunct. In the trial, 2,308 patients at 14 clinics in the U.S. participated. They were all in the first 12 weeks of pregnancy, the women complained of nausea or vomiting.
The study of the drug during the trial declared it as an effective medicine, although no details were provided documenting the trial's success and the fact that the study was never finished.
Ron Vaillancourt, spokesman for Duchesnay, the distributor of the drug in Canada and the United States through Duchesnay USA, states that they have full confidence in the drug's safety and effectiveness.
Villaincourt states that pyridoxine and doxylamine is the most studied drug combination in pregnancy and cites 16 cohort studies and numerous other studies that supports its use as reported in an article by The Virginian-Pilot.
According to Dr. Persaud, he no longer prescribes the medication and has called on Health Canada, the FDA and other medical groups to conduct their own reviews on the drug.
