A glowing review from a very famous mother convinced many a US mum-to-be to ask their doctor for the Diclegis morning sickness pill, but the findings of a new study have put a question mark over the drug’s safety.
In August, Kim Kardashian told her 44 million Instagram followers: ‘OMG. Have you guys heard about this? As you know my #morningsickness has been pretty bad.
‘So I talked to my doctor. He prescribed me #Diclegis. I felt a lot better and most importantly, there was no increased risk to the baby.’
The star, who is mum to North (3) and baby Saint (1), found herself in hot water almost immediately, with many of her fans pointing out that she had failed to mention any of the potential side effects of Diclegis, also known as Diclectin.
According to the manufacturers, the most common side effect experienced by women who use the prescription drug is drowsiness.
They also warn: “Diclegis should be used with caution in women who have certain medical conditions, such as asthma, or eye, stomach or bladder problems.”
Kardashian later updated her post to point out that the FDA had ordered Duchesnay Inc., makers of Diclegis, to include the risks in any promotion of the drug, which she duly did.
Now however, new research calls the efficacy of the drug into question. Apparently, the 1970 study used by the FDA to approve Diclegis may have been flawed.
A paper published this week in the journal PLOS One suggests some issues with the original study into the combination of the two ingredients doxylamine and pyridoxine, known as the Bendectin Study.
Researchers discovered that out of the 2,359 patients who initially enrolled in the trial, 31 per cent never completed it, meaning some important data is missing.
For now, the FDA has reiterated that it believes Diclegis to be safe and effective for the treatment of nausea and vomiting in pregnant women who do not respond to conservative management.
“The FDA’s determination remains unchanged,” according to a statement emailed by FDA spokeswoman Sarah Peddicord.
