The Department recognises the importance of access to medication to treat nausea and vomiting in pregnancy, and hyperemesis gravidarum. The National Institute for Health and Care Excellence (NICE) guideline on antenatal care includes guidance on the advantages and disadvantages of the range of pharmacological treatments for nausea and vomiting in pregnancy to support shared decision making.

Whilst no specific assessment has been made, the Department recognises that there is currently regional variation in the availability of certain medicines like Xonvea between integrated care boards (ICBs). ICBs are responsible for developing local formularies setting out the use of medicines for their local populations, informed by national guidance on clinical effectiveness. This can lead to variation with different local areas taking different decisions to reflect the needs of their local population.

This is why we are progressing the Single National Formulary (SNF), as announced in our 10-Year Health Plan which set out a commitment to move towards a SNF for medicines within the next two years. Over time, an SNF is expected to replace local formulary processes and will be designed to help address inequity and variation in the use of approved medicines; helping to ensure every patient has equitable access to medicines, and that the same medicines are available to patients in an equitable way, in all parts of the country. Work is already underway to deliver the SNF through a phased approach. NHS England will work collaboratively with key stakeholders including NICE and industry throughout the implementation.

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.

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.

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.

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.

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.

Personal Independence Payment (PIP) provides a contribution towards the extra costs that may arise from a long-term disability or health condition.

Entitlement to PIP focuses on the functional impacts of a person’s health condition or disability on their daily life. It is assessed on the basis of needs arising and not on the condition itself, so is available to individuals when they meet the PIP qualifying criteria.

PIP is non-contributory, non-means-tested and can be worth up to £9,747.40 a year, tax free. Receiving a qualifying rate of PIP can act as a ‘passport’ to extra money or higher amounts of other means-tested benefits, such as Universal Credit, Employment and Support Allowance, and Housing Benefit. It can also provide access to council tax reductions and a Disabled Person's Railcard.

Individuals can choose how to use the benefit, in the light of their individual needs and preferences.

Personal Independence Payment (PIP) provides a contribution towards the extra costs that may arise from a long-term disability or health condition.

Entitlement to PIP focuses on the functional impacts of a person’s health condition or disability on their daily life. It is assessed on the basis of needs arising and not on the condition itself, so is available to individuals when they meet the PIP qualifying criteria.

PIP is non-contributory, non-means-tested and can be worth up to £9,747.40 a year, tax free. Receiving a qualifying rate of PIP can act as a ‘passport’ to extra money or higher amounts of other means-tested benefits, such as Universal Credit, Employment and Support Allowance, and Housing Benefit. It can also provide access to council tax reductions and a Disabled Person's Railcard.

Individuals can choose how to use the benefit, in the light of their individual needs and preferences.

The Department, through the National Institute for Health and Care Research, is not currently funding research into the potential impact of exposure to Debendox during pregnancy.