Morning sickness pill scientific backing called into question
pharmafile | January 5, 2017 | News story | Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing | Diclectin, Diclegis, Duchesnay, FDA, kim kardashian, morning sickness
Many women suffer from morning sickness during the early stages of pregnancy and some suffer from hyperemesis gravidarum, acute morning sickness; for those women suffering from these symptoms, there has been medication on offer to relieve symptoms. The drug is known by its brand names Diclegis and Diclectin, and in Canada it is used in half of pregnancies that result in life births.
The basis for the drug’s approval, however, has now been called into question by researchers in Canada. Nav Persaud, a family physician and researcher at St. Michael’s Hospital, is the main author behind the analysis of the drug’s medical background, including a clinical trial conducted 40 years ago forming the backbone upon which the drug was approved. Dr Persaud, and co-author Dr. Rujun Zhang, found serious questions in the clinical trial.
The trial was conducted by Merrell-National Laboratories, a now defunct company, and involved 2,308 patients across 14 clinics in the United States who were suffering from vomiting or nausea. The ‘Bendictin Antinauseant 8-way’ trial, when investigated, appeared to suffer from numerous issues, including: a larger proportion of participants did not complete the one-week trial, outcome data for 37% of participants taking the placebo was not available, 30% of participants were not followed up with, criteria for reporting patient improvement and outcomes were unclear and some data had to be excluded because the FDA questioned its integrity. In an interview, Persaud referred to these issues as “unusual and striking problems.”
Diclegis is a combination of doxylamine and pyridoxine, which has a long and somewhat potted past. It was originally sold under the name Bendectin and was on the market for over 50 years until a spate of lawsuits alleging that the drug caused birth defects. The drug was eventually pulled from the market in 1983 because of falling sales and the legal costs. The drug was picked up again Duchesnay and gained FDA approval, with the highest safety rating, in 2013.
The issues arises because the FDA based its approval partly upon the 40 year-old study, which has now has serious questions raised regarding its integrity. It would be the second time that the drug has raised eyebrows, after it was previously promoted by Kim Kardashian on Instagram (covered in our feature upon Social Media use by pharma) against FDA recommendations after not including any potential risks in taking the medication.
Ben Hargreaves
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