“In some cases, pharmacists have refused to sell doxylamine to women with nausea and vomiting in pregnancy because of the product information, considering the use of doxylamine … to be off-label and thus not indicated or safe,”
“The current RASML requires that the labels of doxylamine-containing medicines indicated for short term use in insomnia include either ‘Not recommended for use by pregnant or breastfeeding women’ or ‘If pregnant or breastfeeding, consult a doctor or pharmacist before use’.
“The TGA is aware that this pregnancy warning statement is inconsistent with the pregnancy classification of doxylamine (Category A in the TGA’s ‘Prescribing medicines in pregnancy database’) and that this creates confusion and concern for pregnant women who are advised to take doxylamine for nausea and vomiting.
“For this reason, the TGA is currently conducting a public consultation seeking comments on the proposal to remove the pregnancy warning from RASML. The consultation commenced on 6 April 2021 and closes on 18 May 2021. Further information about this consultation can be found on the TGA website.”
Researchers found that taking anticholinergic medications for 3 years or more increased the risk for dementia and Alzheimer’s disease. Researchers also found an escalation of risk based upon the cumulative amount of anticholinergic medication taken over time.