Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether the Government has considered introducing a (a) support and (b) compensation scheme for people with lifelong disabilities as a result of exposure to Debendox during pregnancy.

Debendox was originally available as a triple combination of doxylamine succinate, an antihistamine, pyridoxine hydrochloride, a form of vitamin B6, and dicyclomine hydrochloride, an antispasmodic. The product was later reformulated to remove dicyclomine hydrochloride following a review which concluded that dicyclomine did not contribute to the effectiveness of the other two ingredients. In the early 1980s, the medicine was available as a dual combination product, as doxylamine succinate and pyridoxine hydrochloride.

Since July 2018, the dual combination of doxylamine succinate 10 milligram and pyridoxine hydrochloride 10 milligram has been authorised as Xonvea, a safe and effective treatment for nausea and vomiting due to pregnancy in women who do not respond to conservative management, like changes in diet or other non-medicine treatments. As described in the product information for Xonvea, a large amount of data on pregnant women, including two meta-analyses with over 168,000 patients and 18,000 exposures to the doxylamine/pyridoxine combination during first trimester, indicates no malformative nor feto/neonatal toxicity due to doxylamine succinate and pyridoxine hydrochloride.

As with all medicines, the Medicines and Healthcare products Regulatory Agency will keep this issue under review and will carefully evaluate any new evidence which becomes available linking use of Debendox or Xonvea with adverse outcomes in pregnancy.

The Department has not made any recent assessments of the number of people exposed to Debendox and is not considering support or compensation.