Experts have called on the TGA to clarify information about doxylamine, saying pharmacists often deny the drug to pregnant women trying to manage morning sickness
Dr Debra Kennedy, director of the MotherSafe service at the Royal Hospital for Women, which provides advice on medicines safety in pregnancy and breastfeeding, and obstetrics and medicines safety pharmacist Ron Batagol have written to the Medical Journal of Australia to outline their concerns about the labelling of doxylamine.
The medicine, in combination with pyridoxine, is a first-line treatment for nausea and vomiting in pregnancy (NVP), and has been listed as a Category A medicine by the TGA: “Drugs which have been taken by a large number of pregnant women… without any proven increase in the frequency of malformations”.
The pair point out in the letter that “many single-ingredient non-prescription doxylamine products continue to carry misleading product and consumer information”.
“While correctly assigning Category A, they then contradictorily include warnings such as ‘do not use during pregnancy’ and/or ‘studies to prove it is safe for the developing baby have not been done’.
“There is no validity or justification to such statements, which are inconsistent with both available data and the Category A status.”
The pair state in the letter that of the 20,000 calls to MotherSafe each year from health workers and women around NSW, many are from women who have been given “conflicting advice about using doxylamine in pregnancy from pharmacists and other health care professionals.”
“In some cases, pharmacists have refused to sell doxylamine to women with NVP because of the product information, considering the use of doxylamine for NVP to be off-label and thus not indicated or safe.”
Dr Kennedy later told AusDoc’s Kemal Atlay that “notoriously risk-averse” pharmacists frequently refuse to supply the medicine to pregnant women.
“We sometimes tell patients to lie to their pharmacist and say their partner needs the medication for sleep.”
Ron Batagol told the AJP that doxylamine in combination with pyridoxine has been used to combat NVP for around 50 years.
“It’s a very old drug,” he said. “I happened to be working with an epidemiologist in 1985, and we published the world’s first meta-analysis of this medicine, because there were concerns about it being teratogenic. We showed it wasn’t teratogenic.
“It’s now been reapproved by the US Food and Drug Administration in 2014; and in Australia it’s been classified by the TGA as Category A, and has been used by large numbers of women without any evidence of abnormalities.”
But the conflicting labelling advice has led pharmacists and other health professionals, including GPs and obstetricians, to say “we’re not sure if it’s safe,” he said.
“But it’s listed by the College of Obstetricians and Gynaecologists as a first-line treatment. It’s well recognised as a first line treatment.”
The two co-authors wrote in the MJA letter that despite contacting the TGA to have the matter clarified for health professionals and patients, they are “yet to see any progress”.
They also note that the issue highlights “Australia’s confusing pregnancy risk classification” and the need for the TGA to use a more consistent, evidence-based labelling and information protocol than the current alphabetical system.
Ron Batagol encouraged pharmacists to become up to date with the categorisation of doxylamine.
“It’s a real issue,” he said, warning that if untreated, morning sickness can be distressing, and make the management of a healthy pregnancy more difficult “because they may not be getting relief, and may be dehydrated”.