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Valproate use in pregnancy
Evidence shows that 1 in 10 babies (10%) exposed to valproate in pregnancy are born with a congenital malformation (birth defect) – for the general population, the risk is about 2–3%.

MHRA update valproate Pregnancy Prevention information

The Medicines and Healthcare products Regulatory Agency (MHRA) have published updates for valproate medicines and serious harms in pregnancy. The updates include a new Annual Risk Acknowledgement Form and clinical guidance from professional bodies to support compliance with the Pregnancy Prevention Programme.

Ongoing patient survey data suggest that more effort is needed by clinicians to achieve full and timely compliance with the valproate Pregnancy Prevention Programme and meet the goal to rapidly reduce and eventually eliminate the harms of valproate in pregnancy in view of its serious effect in causing birth defects.

The MHRA have updated the Annual Risk Acknowledgement Form, which should be used during annual specialist review of all women and girls of childbearing potential on valproate medicines (irrespective of indication). Specialists should comply with guidance given on the form if they consider the patient is not at risk of pregnancy, including the need for regular review in case her risk status changes.

You can follow developments with valproate by using our Medicines Tracker service which provides users with updates about the medicines they are interested in, including updates to Patient Leaflets, information from medicine regulators and clinical trial information. To track information about this medicine please click on this article and follow the 'About this medicine' link then select 'Follow medicine'.

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EMA restrict use of multiple sclerosis medicine Lemtrada

The European Medicines Agency (EMA) has started a review of Genzyme's multiple sclerosis medicine alemtuzumab, brand name Lemtrada, following new reports of immune-mediated conditions (caused by the body’s defence system not working properly) and problems with the heart and blood vessels with the medicine, including fatal cases.

As a temporary measure while the review is ongoing, Lemtrada should only be started in adults with relapsing-remitting multiple sclerosis that is highly active despite treatment with at least two disease modifying therapies (a type of multiple sclerosis medicine) or where other disease-modifying therapies cannot be used. Patients being treated with Lemtrada who are benefitting from it may continue treatment in consultation with their doctor.

Information for Patients
New cases of side effects have been reported with Lemtrada, including some affecting the heart, blood vessels, lungs and liver.

You should get medical help immediately if you experience symptoms of:
  • acute (sudden) heart problems (usually within 1–3 days of receiving the medicine): such as trouble breathing and chest pain
  • bleeding in lungs: such as trouble breathing and coughing up blood
  • stroke and tears in blood vessels supplying the brain: such as drooping of the face, sudden severe headache, weakness on one side, difficulty with speech or neck pain
  • liver problems: such as yellow skin or eyes, dark urine, and bleeding or bruising more easily than normal
  • an inflammatory condition known as haemophagocytic lymphohistiocytosis: with symptoms of fever, swollen glands, bruising and skin rash

If you have any of these symptoms, contact your doctor who will examine you and may consider stopping Lemtrada and switching you to an alternative treatment.

An in-depth review of Lemtrada is ongoing and further information will be provided as soon as it is available.

While the review is ongoing, Lemtrada will only be prescribed to new patients if other medicines have not worked or are not suitable.

Speak with your doctor if you have questions or concerns about your treatment.

You can follow developments with this medicine using our Medicines Tracker service which provides users with updates about the medicines they are interested in, including updates to Patient Leaflets, information from medicine regulators and clinical trial information. To track information about this medicine please click on this article and follow the 'About this medicine' link then select 'Follow medicine'.

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Xeljanz▼ (tofacitinib) in treating rheumatoid arthritis - safety update

The European Medicines Agency (EMA) is advising healthcare professionals and patients not to exceed the recommended dose of Xeljanz (tofacitinib) when treating rheumatoid arthritis. The advice follows early results from an ongoing study in patients with rheumatoid arthritis which showed an increased risk of blood clots in the lungs and death when the normal dose of 5 mg twice daily was doubled.

In the EU, 5 mg twice daily is the authorised dose for rheumatoid arthritis and psoriatic arthritis. The higher dose of 10 mg twice daily is approved for the initial treatment of patients with ulcerative colitis.

The EMA is assessing the early results and will consider if any regulatory action is needed. In the meantime, patients with rheumatoid arthritis who are receiving Xeljanz at 10 mg twice daily in the study will have their dose reduced to 5 mg twice daily for the remaining duration of the study.

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Keep Me Informed - Conditions and medicines added in March 2019

The following conditions have been added to Keep Me Informed since March 1st 2019.
  • Cholecystitis
  • Liver disease
  • Vaccination
  • Polyneuropathy
  • Amyloidosis
  • Smith-Magenis syndrome
  • Autism
For information about medicines added, NICE guidelines, and patient safety information, please see the full article.

You can follow any of these conditions using Keep Me Informed, which provides users with updates about the conditions they are interested in, including updates to NICE guidelines, patient leaflets, risk management materials, information from medicine regulators and clinical trial information. To track information about these conditions please use the 'Select conditions' button.

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NICE encourages use of greener asthma inhalers

The National Institute for Health and Care Excellence (NICE) is encouraging asthma patients on using greener asthma inhalers.

NICE highlight a new patient decision aid indicating which inhalers have a higher carbon footprint than others.

The aid will help people with asthma, alongside health professionals, to identify which inhalers could meet their needs and control their symptoms.

Where several inhalers could be viable options, patients can opt for the more environmentally friendly option, which may help to cut the health service’s carbon footprint.

The new aid, partially funded by the Sustainable Development Unit, also says that all used inhalers should be returned to local pharmacies for environmentally safe disposal or recycling.

Feature
The National Institute for Health and Care Excellence (NICE) says everyone should be able to choose the inhaler they find easiest to use. NICE also says that everyone should have the way they use their inhaler checked regularly. If needed, people should be given advice on how to improve their technique

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NICE publish updated medicines safety priorities for Asthma

The National Institute for Health and Care Excellence (NICE) have updated the medicines safety priorities for asthma.

The update covers:
  • National review of asthma deaths
  • Self-management and reviews
  • Decreasing maintenance therapy
  • Practice examples and shared learning
Whilst not specific guidance, the therapeutic topic of asthma summarises the evidence base on asthma: medicines safety priorities.


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Lokelma - new product for treating hyperkalaemia

AstraZeneca have launched their treatment for hyperkalaemia (high levels of potassium in the blood). The medicine contains the ingredient sodium zirconium cyclosilicate (brand name Lokelma).

Lokelma captures potassium in the blood in exchange for hydrogen and sodium atoms. The exchange with potassium ions occurs throughout the gastrointestinal tract with onset in the upper part of the gastrointestinal tract. The trapped potassium ions are excreted from the body via the faeces, thereby reducing any excess and resolving hyperkalaemia.

Lokelma is licensed for the treatment of hyperkalaemia in adult patients.


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Listening to the myeloma patient voice is difficult – but it still needs to be done

In an article published by Pharmaphorum written by Amanda Burrell, she speaks to Simon Ridley, director of research at Myeloma UK, on the role of the patient in influencing the healthcare community.

The shift towards including the 'patient voice' is evident in many conditions and by many organisations such as the NHS, NICE and the pharmaceutical industry.

Engaging with patients provides these groups with a view that can be factored into many facets of care, including the identification of important issues that affect patients' lives over and above the standard care models.

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NICE guidance - Lung cancer: diagnosis and management

The National Institute for Health and Care Excellence (NICE) have published an updated their guideline on the diagnosis and management of lung cancer.

The guideline aims to improve outcomes for patients by ensuring that the most effective tests and treatments are used, and that people have access to suitable palliative care and follow-up.

The guidelines are intended to inform:
  • People with lung cancer and their families and carers
  • Healthcare professionals
  • Commissioners and providers
NICE have reviewed the evidence and made new recommendations on:
  • intrathoracic lymph node assessment
  • brain imaging for people with non-small-cell lung cancer
  • radical radiotherapy (including stereotactic ablative radiotherapy [SABR]) for people with non-small-cell lung cancer
  • chemoradiotherapy and surgery for people with stage IIIA-N2 non-small-cell lung cancer
  • thoracic radiotherapy and prophylactic cranial irradiation for people with small-cell lung cancer
This guideline (NG122) updates and replaces NICE guideline CG121 (April 2011).

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NHS online tool for predicting breast cancer

The NHS have published a 'Predict' tool that helps show how breast cancer treatments after surgery might improve survival rates.

Once details about the patient and their cancer have been entered, the tool will show how different treatments would be expected to improve survival rates up to 15 years after diagnosis. This is based on data from similar women in the past. It is important to note that these treatments have side effects which should also be considered when deciding on a treatment.

The tool is designed to be used by the patient and their doctor.

For more information see full article.

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Keep Me Informed - inclusion of rare disease classification

We have introduced the category of 'Rare diseases and conditions' to Keep Me Informed.

Please go to the full article to read an introduction from Cystic Fibrosis patient and European Health Parliament Member, Thomas Smith.

We have classified over 100 rare conditions in addition, where appropriate, to their collective description (such as cancer, respiratory disease).

According to Rare Diseases UK a rare disease is defined by the European Union as one that affects fewer than 1 in 2,000 of the general population. There are between 6,000 and 8,000 known rare diseases and around five new rare diseases are described in medical literature each week. Some 6% of the population are affected by a rare disease.

In the USA a condition that affects under 200,000 people, is considered a rare condition.

We have introduced links to the National Organization for Rare Disease (NORD) database that provides information on over 1200 rare conditions.

Our future plans include working with patient organisations to provide resources for patients, not only for their condition, but also for other conditions they may experience.

For further information on rare conditions, see the main article.

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NHS publish online tool that helps men choose best prostate cancer treatment

The NHS have published an online tool to help men with prostate cancer

The researchers who developed the tool were from the University of Cambridge, the National Cancer Registration and Analysis Service in the UK, and from the Singapore General Hospital in Singapore.

The tool can show the potential effects of treatments such as surgery or radiotherapy, compared with "wait and see" approaches.

The tool is specifically for use in men with prostate cancer that's localised and not spread outside of the prostate gland.

For more information see full article (click on this email).

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Addition to medicines database - Kuvan for phenylketonuria

We are currently updating our medicines database to support the Medicines Tracker function.

We have updated the medicine containing the ingredient sapropterin, brand name Kuvan.

Kuvan is a medicine that is used to treat high blood levels of phenylalanine in adults and children of all ages with the genetic disorders phenylketonuria (PKU) or tetrahydrobiopterin (BH4) deficiency.

Patients with these disorders cannot process the amino acid phenylalanine from dietary protein, and as a result the amino acid builds up in the blood to abnormally high levels, causing problems in the nervous system.

Because the number of patients with conditions leading to high phenylalanine levels is low, the conditions are considered ‘rare’, and Kuvan was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 8 June 2004.

Kuvan contains the active substance sapropterin dihydrochloride.

Because the number of patients with conditions leading to high phenylalanine levels is low, the conditions are considered ‘rare’, and Kuvan was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 8 June 2004.

This medicine can only be obtained with a prescription.

For more information see full article.

You can follow this medicine using our Medicines Tracker service which provides users with updates about the medicines they are interested in, including updates to Patient Leaflets, information from medicine regulators and clinical trial information. To track information about this medicine please click on this article and follow the 'About this medicine' link then select 'Follow medicine'.

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Keep Me Informed - Medicines Tracker update

Following the release of the latest version of the Keep Me Informed browser, including our new Medicine Tracker, we are pleased to advise you that medicines can now be searched for using the ingredient name(s).

This will present the brand name and the ingredient names.

We are working on the following improvements:
  • finalising our clinical coding efforts to ensure that Keep Me Informed can be integrated into into other applications such as GP and pharmacy systems, organisations and NHS information services
  • provide personal health record functionality such as interaction checking and side effect reporting
  • launch our Patient Safety Programme to ensure all patients can access important new information about their medicines
  • create a patient reported outcome process
  • expand our content sources (including clinical trial information)
  • make Keep Me Informed available in other countries
We want to thank all our users for their support and wish you seasons greetings and a happy New Year.

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Hypertension in adults: diagnosis and management

NICE has published its draft updated guideline on the diagnosis and treatment of high blood pressure (hypertension) for public consultation.

In the biggest change to NICE’s previous guidance published in 2011, the level of a person’s cardiovascular disease risk at which treatment for high blood pressure can be started has been reduced.

The draft guideline recommends that blood pressure lowering drugs should be offered to people aged under 80 with a diagnosis of stage 1 hypertension who have a 10% or greater risk of developing cardiovascular disease within the next 10 years.

It is estimated that around 450,000 men and 270,000 women would fall into this category. However, it is likely that the impact of the new recommendations will in fact be lower as some estimates suggest half of people in this category are already receiving treatment.

The draft guideline also considered new studies suggesting people with blood pressure below the level at which high blood pressure is usually diagnosed (140/90mmHg) might also benefit from medication. It also looked at what the effect would be of lowering the blood pressure target for people on treatment. However, some of these studies, which formed a key part of the evidence reviewed in other recent international hypertension guidelines, were difficult to interpret because they included people who had other conditions that would also raise their cardiovascular disease risk, such as chronic kidney disease. Therefore, these studies could not be directly used to inform the recommendations in this draft guidance.

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NICE approve tisagenlecleucel (Kymriah▼) for use in treating lymphoma under Cancer Drug Fund

The National Institute for Health and Care Excellence (NICE) has approved the use of Novartis' lymphoma treatment tisagenlecleucel, brand name Kymriah.

Kymriah is recommended for use within the Cancer Drugs Fund as an option for treating relapsed or refractory diffuse large B-cell lymphoma in adults after 2 or more systemic therapies and only if the conditions in the managed access agreement are followed.

Managed access schemes are agreements between the manufacturer and the NHS, usually specifying a set of conditions under which reimbursement for the medicine will be made.

NICE state that:

'More evidence on tisagenlecleucel is being collected, until June 2023. After this NICE will decide whether or not to recommend it for use on the NHS and update the guidance. It will be available through the Cancer Drugs Fund until then.

If you are not eligible for tisagenlecleucel therapy but are already having it, you should be able to continue until you and your doctor decide when best to stop.'

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Update on the substitution of medicines in the event of shortages

Following the governments January publication of a policy paper on obtaining medications in the event of no deal Brexit, we would like to alert Keep Me Informed users to the conditions and medicines where substitution of medicines should be approached with caution.

The government stated that around three-quarters of the medicines and over half the devices and one-use medical products (such as syringes) that the NHS uses, come into the UK via the EU.

'The government has analysed the supply chain, made plans to reduce the risk of disruption, and given instructions to pharmaceutical companies to ensure that they have adequate stocks to cope with any potential delays at the border.'

Anti epileptic treatments are one group where consistent use of the same prescribed medicine is required.

Other considerations are where medicines should be prescribed by brand name. For example, all biologicals should be prescribed by brand name.

This is due to a variety of factors such as:
  • bioavailability differences
  • modified-release characteristics
  • formulation difference of effect
  • patient familiarity
  • different licensed indications
The UK Medicines Information group published guidance in 2017. A link to this document is available in the main article (click on this headline to access).

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Public Health England launches 'Cervical Screening Saves Lives' campaign

Public Health England have launched on a new drive to encourage women to ensure they undertake cervical screening.

The PHE campaign is designed to boost the number of women taking screening tests after attendance levels reached a 20-year low.

PHE state that 1 in 4 women are not undertaking screening even though they are entitled to. The campaign will encourage women to respond to their cervical screening invitation letter, and if they missed their last screening, to book an appointment at their GP practice.

Around 2,600 women are diagnosed with cervical cancer in England each year, and around 690 women die from the disease, which is 2 deaths every day. It is estimated that if everyone attended screening regularly, 83% of cervical cancer cases could be prevented.

New research from PHE shows that nearly all women eligible for screening (90%) would be likely to take a test that could help prevent cancer - and of those who have attended screening, 9 in 10 (94%) would encourage others who are worried to attend their cervical screening. Despite this, screening is at a 20-year low, with 1 in 4 eligible women (those aged 25 to 64) in the UK not attending their test.

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Keep Me Informed - Conditions and medicines added in January and February 2019

The following conditions have been added to Keep Me Informed since January 1st 2019.
  • Measles
  • Mumps
  • Rubella
  • Primary immunodeficiency disorders (PID)
  • Batten's disease (Neuronal ceroid lipofuscinosis)
  • Chronic myelomonocytic leukemia (CMML)
  • Chronic fatigue syndrome (ME)
  • Pruritis
  • Priapism
  • Liposarcoma
  • Pre-eclampsia
  • Photosensitivity reactions including solar urticaria, chemical photosensitization and polymorphous light eruption
For information about medicines added, NICE guidelines, and patient safety warnings, please see the full article.

You can follow any of these conditions using Keep Me Informed, which provides users with updates about the conditions they are interested in, including updates to NICE guidelines, patient leaflets, risk management materials, information from medicine regulators and clinical trial information. To track information about these conditions please use the 'Select conditions' button.

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NICE guidance recommending abemaciclib (Verzenios▼, Lilly) in treating breast cancer

The National Institute for Health and Care Excellence (NICE) has published guidance for Lilly's breast cancer treatment abemaciclib (brand name Verzenios) with another medicine, an aromatase inhibitor, for previously untreated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer.

NICE state that 'Abemaciclib with an aromatase inhibitor is recommended as an option for treating breast cancer that is:
  • locally advanced or metastatic - the cancer is 'advanced' at the original site or has spread to other parts of the body
  • hormone receptor-positive - the cancer cells grow in response to the hormone oestrogen or progesterone
  • human epidermal growth factor receptor 2 (HER2)-negative - where the cancer cells lack the HER2 protein on their surface. HER2 helps control cell growth.
NICE have approved abemaciclib for treating breast cancer as first line endocrine-based therapy in adults.

Abemaciclib is recommended only if the manufacturer provides it according to the commercial arrangement.

Commercial arrangements are agreements between the manufacturer and the NHS, usually specifying a set of conditions under which reimbursement for the medicine will be made.

For more information see full article.

You can follow this medicine using our Medicines Tracker service which provides users with updates about the medicines they are interested in, including updates to Patient Leaflets, information from medicine regulators and clinical trial information. To track information about this medicine please click on this article and follow the 'About this medicine' link then select 'Follow medicine'.

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NICE publish draft guidelines recommending use of pertuzumab (Perjeta, Roche) in the early treatment breast cancer

The National Institute for Health and Care Excellence (NICE) has published final draft guidance for Roche's breast cancer treatment pertuzumab (brand name Perjeta) for treating early HER2-positive breast cancer in people whose disease has spread to their lymph nodes. .

NICE state that 'this positive recommendation is for people who have had surgery for their breast cancer and whose cancer has already spread to their lymph nodes. The estimated 2700 people in this subgroup have a higher risk of their cancer returning.

The evidence shows that adding pertuzumab to trastuzumab and chemotherapy after surgery increased the proportion of people whose disease didn’t spread. However, there is a lack of evidence on how long, if at all, adding pertuzumab might increase the overall length of time people live.'

Pertuzumab, with intravenous trastuzumab and chemotherapy, is recommended for the adjuvant treatment of human epidermal growth factor receptor 2 (HER2)-positive early stage breast cancer in adults, only if:
  • they have lymph-node-positive disease
  • the company provides it according to the commercial arrangement
Commercial arrangements are agreements between the manufacturer and the NHS, usually specifying a set of conditions under which reimbursement for the medicine will be made.

A final decision is expected to be published on 20th March 2019.

For more information see full article.

You can follow this medicine using our Medicines Tracker service which provides users with updates about the medicines they are interested in, including updates to Patient Leaflets, information from medicine regulators and clinical trial information. To track information about this medicine please click on this article and follow the 'About this medicine' link then select 'Follow medicine'.

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MHRA drug safety update for carbimazole

The Medicines and Healthcare products Regulatory Agency (MHRA) have issued a drug safety update for the hyperthyroidism treatment carbimazole. The update states that cases of acute pancreatitis have been reported very infrequently during treatment with carbimazole

Acute pancreatitis is a condition where the pancreas becomes inflamed (swollen) over a short period of time.

The pancreas is a small organ, located behind the stomach, that helps with digestion.

Symptoms of acute pancreatitis include:
  • suddenly getting severe pain in the centre of your tummy (abdomen)
  • feeling or being sick
  • diarrhoea
  • a high temperature of 38C or more (fever)
The MHRA advice is:
  • if acute pancreatitis occurs, stop carbimazole treatment immediately
  • do not use carbimazole in patients with a history of acute pancreatitis in association with previous treatment
  • re-exposure may result in life-threatening acute pancreatitis with a decreased time to onset
  • report suspected adverse drug reactions to the Yellow Card Scheme immediately
For more information see full article.

You can follow this medicine using our Medicines Tracker service which provides users with updates about the medicines they are interested in, including updates to Patient Leaflets, information from medicine regulators and clinical trial information. To track information about this medicine please click on this article and follow the 'About this medicine' link then select 'Follow medicine'.

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NICE publish draft guidance recommending use of brigatinib (brand name Alunbrig▼) for the treatment of lung cancer

The National Institute for Health and Care Excellence (NICE) has published final draft guidance for Takeda's lung cancer treatment brigatinib (brand name Alunbrig) for treating liver cancer.

NICE state that 'brigatinib is recommended, within its marketing authorisation, for treating anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC) in adults who have already had crizotinib. It is recommended only if the company provides it according to the commercial arrangement.'

Commercial arrangements are agreements between the manufacturer and the NHS, usually specifying a set of conditions under which reimbursement for the medicine will be made.

This means that Alunbrig will be available for use by NHS England and Wales when the determination is published in March 2019.

For more information see full article.

You can follow this medicine using our Medicines Tracker service which provides users with updates about the medicines they are interested in, including updates to Patient Leaflets, information from medicine regulators and clinical trial information. To track information about this medicine please click on this article and follow the 'About this medicine' link then select 'Follow medicine'.

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