As with all medicines, the Medicines and Healthcare products Regulatory Agency (MHRA) and the Government’s independent expert advisory body the Commission on Human Medicines (CHM) keep the safety of osteoporosis drugs under continual review including their effects on the jaw and on bone health. The MHRA, together with the CHM, ensures that the product information for osteoporosis medicines contains up to date information and issues updated advice as appropriate.

Warnings about the risks of osteonecrosis of the jaw (severe bone damage in the jaw) and atypical fractures of the femur (unusual fracture of the thigh bone) are included in the product information (Summary of Product Characteristics for healthcare professionals and Patient Information Leaflet for patients) for all medicines containing bisphosphonates or denosumab which are used in the treatment of osteoporosis. New information and advice on these risks have been communicated to healthcare professionals in the MHRAsafety bulletin in 2006, 2007, 2009, 2011, 2013 and 2014 as new information has become available. A patient reminder card on the risk of osteonecrosis of the jaw is currently being introduced for patients treated with denosumab and bisphosphonates given by injection and healthcare professionals have been informed of this new measure via the MHRA bulletin.

Information about the recognised risks of osteonecrosis of the jaw and atypical fractures of the femur with bisphosphonates and denosumab is also included in the 2014 ‘Osteoporosis - Clinical Guideline for prevention and treatment’ developed by the National Osteoporosis Guideline Group which includes the Royal College of Physicians.

Prescribing information is available from 1991; annual figures are provided from 1991 to 2014 for antidepressant prescription items dispensed and the net ingredient cost (NIC).

Source: Prescription Cost Analysis (PCA) system data provided by the Health and Social Care Information Centre

Note: The values for NIC have fluctuated over the years; reasons for this will include: the number of antidepressants available on the market, shifts in prescribing practice following national policy and guidance, and the expiry of patents for some medicines and increased use of lower priced generic alternatives. Price changes for generic medicines have strongly influenced the overall costs in recent years.

Medicines should only be prescribed when necessary and in all cases the benefit should be considered in relation to the risk involved. The options should be discussed carefully with the patient.

The National Institute for Health and Care Excellence (NICE) has published a range of clinical guidelines, relevant to the prescribing of anti-depressant medication.

Advice on the prescribing of anti-depressants is available in the BNF, which is made available free of charge to National Health Service prescribers. Best practice guidance may also be produced by the Royal College of Psychiatrists.

In addition, the Medicines and Healthcare products Regulatory Agency (MHRA) ensures that the product information available to all doctors and patients contains authoritative and up to date essential information on how to prescribe antidepressants and on the benefits and risks of treatment, including the risk of withdrawal. In addition the MHRA issues updated advice as appropriate and communications to healthcare professionals via the letters to healthcare professionals, the MHRA website and also Drug Safety Update.

A total of 2,624 spontaneous suspected serious adverse reaction reports (ADRs) with human papilloma virus (HPV) vaccines have been reported to the Medicines and Healthcare products Regulatory Agency (MHRA) via the Yellow Card Scheme up to 7 July 2015.

To date more than eight million doses of HPV vaccine have been given in the United Kingdom since 2008, with close to 90% eligible teenagers vaccinated. The vast majority of suspected side effects reported so far relate to those we would expect with most types of vaccine; these are most commonly dizziness, headache, nausea, sore arms, vomiting, general malaise, tiredness, fever, and rashes. These tend to be mild and transient. Many serious reports relate to immediate fainting, which is not necessarily a side effect of the vaccine but a response that any type of needle insertion can provoke in some people.

The following table provides a breakdown of UK suspected spontaneous ADRs received via the Yellow card Scheme in association with all vaccines on the immunisation schedule. The table provides the total number of reports, the total number of serious reports and the number of serious reports followed up.

UK suspected spontaneous ADRs received via the Yellow card Scheme in association with all vaccines on the immunisation schedule.

* Percentage provided to the nearest whole number

It should be noted that a Yellow Card report is not proof of a side effect occurring, but a suspicion by the reporter that the vaccine may have been the cause. Yellow Card data cannot be used as a reliable indicator of the frequency of suspected ADRs to vaccines or medicines. The level of ADR reporting may fluctuate between given years due to a variety of reasons such as a medicine being new (reporting rates are generally higher when a product is first introduced), stimulated interest/publicity and variations in exposure to the medicine. Comparisons of ADR reporting rates would be an invalid estimate of relative vaccine safety.

Every reporter to the Yellow Card scheme receives an acknowledgement which asks that any new information relating to the case be reported. Follow up procedures for Yellow Card reports are in place and are designed to ensure that relevant information is sought if this is missing from reports of serious reactions which could potentially be new signals. While in an ideal world full details would be obtained for every report, given there are over 750,000 reports on the database with around 30,000 new reports each year, it will never be possible to ensure all reports on the database are complete. There are a number of difficulties with achieving satisfactory follow up. Time pressure on potential reporters has been identified as one of the reasons for under-reporting adverse reactions through the Yellow Card Scheme. This issue also applies to requests for follow up information and therefore there is a need to be selective and focussed about the reports for which follow up information is requested.

The HPV vaccine has a very good safety record, and surveillance shows it has contributed to a significant decrease in rates of infection with the two main cancer-causing human papillomaviruses. The UK programme is eventually expected to prevent hundreds of deaths from cervical cancer every year.

All licensed medicines and vaccines, including Gardasil and Cervarix, are subject to post-marketing surveillance (also known as pharmacovigilance). Gardasil and Cervarix are authorised via the centralised procedure with the European Commission as Licensing Authority. The post-marketing surveillance for centrally authorised products is underpinned by European Legislation (Regulation (EU) No 1027/2012) which puts requirements on national competent authorities in member states, the European Medicines Agency and marketing authorisation holders to collect data on safety of medicines and vaccines, assess any new issues, take action to minimise risks and monitor the effectiveness of any action taken.

Gardasil and Cervarix have been subject to post-marketing surveillance since the time of marketing. Gardasil and Cervarix have a very good safety record, and surveillance shows they have contributed to a significant decrease in rates of infection with the two main cancer-causing human papillomaviruses. The United Kingdom programme is eventually expected to prevent hundreds of deaths from cervical cancer every year.

As of 7 July 2015, adverse events with an unknown outcome make up 22% of the total number of serious suspected adverse events reported in association with Cervarix.

The Black Triangle Scheme for intensive monitoring of medicines ran for many years in the United Kingdom but was replaced by the European equivalent in 2012.

Cervarix was first authorised in September 2007. For the first two years of the Cervarix immunisation programme in the UK, to complement the Black Triangle Scheme, the Medicines and Healthcare products Regulatory Agency (MHRA) put in place an ‘enhanced’ safety monitoring strategy involving a multi-disciplinary team of scientists. Cumulative safety summaries were published on the MHRA website each week for the public to see.

The Black Triangle Scheme, when it was in place, intensively monitored new medicines to ensure that any new safety hazards were identified promptly. The Commission on Human Medicines and the MHRA encouraged the reporting of all suspected reactions to newer drugs and vaccines, which were denoted by an inverted black triangle symbol.

Every reporter to the Yellow Card scheme receives an acknowledgement which asks that any new information relating to the case be reported. Follow up procedures for Yellow Card reports are in place and are designed to ensure that relevant information is sought if this is missing from reports of serious reactions which could potentially be new signals. While in an ideal world full details would be obtained for every report, given there are over 750,000 reports on the database with around 30,000 new reports each year, it will never be possible to ensure all reports on the database are complete. There are a number of difficulties with achieving satisfactory follow up. Time pressure on potential reporters has been identified as one of the reasons for under-reporting adverse reactions through the Yellow Card Scheme. This issue also applies to requests for follow up information and therefore there is a need to be selective and focussed about the reports for which follow up information is requested.

My Answer of 16 June (HL229) confirmed a total of 2,598 serious suspected adverse reaction reports with human papilloma virus (HPV) vaccines had been reported via the Yellow Card Scheme up to 3 June 2015.

In relation to the additional serious suspected adverse reaction reports received since 3 June 2015, this number is in line with the average number of such reports received per month since the start of the United Kingdom HPV vaccination program.

The safety of all vaccines, including HPV, remains under continual review and appropriate action will be taken if any important new risks are confirmed.

Lariam (mefloquine), is an extremely effective antimalarial and is one of a number of antimalarials for travellers currently recommended by the Advisory Committee on Malaria Prevention (ACMP), an expert advisory committee of Public Health England (PHE) established in 1998 to formulate evidence-based guidelines on malaria prevention in the United Kingdom.

The use of mefloquine, for travellers, including military personnel, to high risk areas should be based on an individual risk assessment that takes into consideration the destination of travel, planned activities while travelling and the individual’s current health and medical history.

The ACMP regularly reviews data on safety and efficacy of all antimalarials. Whenever new evidence about antimalarials appears the ACMP considers this as part of its continuous process of developing advice.

The ACMP will be meeting in summer 2015 to finalise the 2015 revision of the ACMP guidelines. This meeting will review current evidence on the use of mefloquine, including data provided by Roche, and recommendations made by other countries including the United States with regard to the use of mefloquine for malaria prevention.

Between 1 April 2007 and 31 December 2014, 16,473 UK Regular Armed Forces personnel were prescribed mefloquine (commercial name Lariam). Up to 31 March 2015, 1,066 (6 per cent) were assessed as having a mental health disorder at their initial assessment at an MOD Department for Community Mental Health (DCMH) or on admission to an MOD in-patient provider. It is not possible from centrally-held data to identify whether an assessment is associated with a patient having taken mefloquine.

Former Service men and women are treated by the NHS and their status as a veteran is not always recorded on their NHS medical records. It is therefore not possible to say how many former Service personnel have required psychiatric treatment after taking mefloquine.

Between 1 April 2007 and 31 December 2014, 536 UK Armed Forces personnel were prescribed mefloquine prior to or whilst on deployment to Afghanistan. Up to 31 March 2015, 43 (8 per cent) were assessed as having a mental health disorder at their initial assessment at an MOD DCMH or on admission to an MOD in-patient provider.

Between 1 April 2007 and 31 December 2014, 16,473 UK Regular Armed Forces personnel were prescribed mefloquine (commercial name Lariam). Up to 31 March 2015, 1,066 (6 per cent) were assessed as having a mental health disorder at their initial assessment at an MOD Department for Community Mental Health (DCMH) or on admission to an MOD in-patient provider. It is not possible from centrally-held data to identify whether an assessment is associated with a patient having taken mefloquine.

Former Service men and women are treated by the NHS and their status as a veteran is not always recorded on their NHS medical records. It is therefore not possible to say how many former Service personnel have required psychiatric treatment after taking mefloquine.

Between 1 April 2007 and 31 December 2014, 536 UK Armed Forces personnel were prescribed mefloquine prior to or whilst on deployment to Afghanistan. Up to 31 March 2015, 43 (8 per cent) were assessed as having a mental health disorder at their initial assessment at an MOD DCMH or on admission to an MOD in-patient provider.

There are no plans to change existing advice on the use of paracetamol during pregnancy for women carrying male foetuses. Pregnant women are advised to only take medication, including paracetamol, if absolutely necessary, in the lowest effective dose and for the shortest period of time. If a painful condition persists for more than one to two days, women should consult their midwife or doctor for advice.

Q5

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Teresa Pearce (Erith and Thamesmead) (Lab):

Historically, 500 babies per year are damaged in the womb by sodium valproate, a drug prescribed for epilepsy. Although GPs are now more aware of the risks, the national archives show that the risks were well known by drug companies and Government as far back as 1973, yet mothers were kept in the dark. Will the Prime Minister urge his Health Secretary to meet me and a delegation of mothers who are affected by this issue to discuss their case?