Category Archives: News

EDQM suspend Mylan laboratories Valsartan license

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Authorities in the EU are taking action after an impurity, N-nitrosodiethylamine (NDEA), was found in some batches of valsartan made by Mylan Laboratories Limited in Hyderabad, India.

European Directorate for the Quality of Medicines has now suspended the manufacturer’s CEP, effectively prohibiting the use of its valsartan in EU medicines.

In addition, national authorities in the EU have started recalling affected batches of medicines containing Mylan’s valsartan and are conducting further tests to determine the extent of the contamination.

NDEA and the related compound N-nitrosodimethylamine (NDMA), which have been seen in ‘sartans’ from other manufacturers, are classified as probable human carcinogens (substances that could cause cancer).

Companies marketing sartan medicines in the EU have been asked to test their products for these impurities. Additional testing is being carried out by EU laboratories. The European Medicines Agency will update the public as soon as new information becomes available.

 

Source: EMA

 

Theft of medicines: Gabapentin Noumed 300mg Capsules, Alvesco AZ

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Silverdale Healthcare Ltd has recently been informed of the theft of a quantity of the following medicine(s):

Ref: INC 13796

 

Date of incident: 17 July 2018

Manufacturer: Noumed Life Sciences Limited

Product: Gabapentin Noumed 300mg Capsules

 

Details of the missing medicines are listed below:

 

Product Description PL No. Batch No. Exipry Date Quantity Missing (Cartons)
Gabapentin

Noumed,300mg

Capsules

PL 44041/0020

 

4A0235

4A0236

4A0237

March 2020

March 2020

March 2020

4422

3456

960

 

The following has also been subject to being stolen:

Ref: INC 13780

Date of incident: 16/07/2018

MA holder is Astra Zeneca UK Ltd

Product: 18 units of Alvesco (see table below)

PL 17901/0297-0298

 

Batch details are as follows – Two units from each batch were in the two boxes in question – Total of

18 units:

Batch Product Desciption Expiry
     
GTE017A Alvesco P&B 160mcg 120D Austra 7CI312LFC 09.04.2021
GSL014B Alvesco P&B 160mcg 60D Neth 7CI306LHA 06.11.2020
GTC037D Alvesco P&B 80mcg 60D Russia 7CI206LRU 13.03.2021
GTC034G Alvesco P&B 80mcg 120D Sloven 7CI212LSL 01.02.2021
GTC037C Alvesco P&B 80mcg 60D France 7CI206LMF 12.02.2021
GSL014A Alvesco P&B 160mcg 60D Spain 7CI306LSP 06.11.2020
GTC035A Alvesco P&B 160mcg 60D Poland 7CI306LPO 01.02.2021
GTC059B Alvesco P&B 160mcg 60D Czech 7CI306LCK 24.02.2021
GTA122D Alvesco P&B 160mcg 120D Fin 7CI312LRA 28.12.2020

 

Source – MHRA

Class 1 Medicines Recall: Action Now – including out of hours Pharmacy Level Recall

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Pharmacies in the UK are being advised to recall all batches of valsartan containing medicines made by Actavis Group PTC (now Accord), Aptil Pharma Limited (now Torrent) and Dexcel Pharma Ltd due to contamination.

Brief description of the problem

All batches of the above products are being recalled at a European level due to possible contamination with an impurity N-nitrosodimethylamine (NDMA) which has genotoxic and carcinogenic potential.

Product details

Product Name Marketing Authorisation Holder PL number
VALSARTAN 40MG CAPSULES, HARD DEXCEL PHARMA LIMITED PL 14017/0192
VALSARTAN 80MG CAPSULES, HARD DEXCEL PHARMA LIMITED PL 14017/0193
VALSARTAN 160MG CAPSULES, HARD DEXCEL PHARMA LIMITED PL 14017/0194
VALSARTAN 40MG FILM-COATED TABLETS ACTAVIS GROUP PTC EHF PL 30306/0109
VALSARTAN 80MG FILM-COATED TABLETS ACTAVIS GROUP PTC EHF PL 30306/0110
VALSARTAN 160MG FILM-COATED TABLETS ACTAVIS GROUP PTC EHF PL 30306/0111
VALSARTAN 320MG FILM-COATED TABLETS ACTAVIS GROUP PTC EHF PL 30306/0405

Healthcare professionals and wholesalers

Stop dispensing the products listed above immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process. An investigation into other potentially impacted products is currently being undertaken and further updates will be provided as the investigation progresses.

Class 2 Medicines Recall:Own-brand children’s glycerine and blackcurrant cough syrups manufactured by Bell, Sons & Co.

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Bell, Sons & Co is recalling several batches of own-brand children’s blackcurrant cough syrups due to a small number of reports of mould.

Product information

Company name

Bell, Sons & Co.

Product description

Asda Children’s Dry Cough Syrup Glycerol Blackcurrant Flavour;

Bell’s Healthcare Children’s Dry Cough Glycerin 0.75g/5ml Syrup;

Morrisons Children’s Dry Tickly Cough Glycerin 0.75g/5ml Oral Solution;

Numark Children’s Dry Cough 0.75 g/5 ml Oral Solution;

Sainsbury’s Children’s Dry Cough 0.75g/5ml Syrup;

Superdrug Children’s Dry Tickly Cough Glycerin 0.75 g/5 ml Oral Solution;

Tesco Children’s Dry Cough Syrup;

Wilko Tickly Cough 0.75g/5ml Oral Solution

Brand & Product Description Batch Number D Code Expiry Date Pack Size Date Released
Asda Children’s Dry Cough Syrup Glycerol Blackcurrant Flavour 274V1 D10-5120 01-Aug-2020 200 ml 27/09/2017
Asda Children’s Dry Cough Syrup Glycerol Blackcurrant Flavour 276V1 D10-5120 01-Oct-2020 200 ml 31/10/2017
Asda Children’s Dry Cough Syrup Glycerol Blackcurrant Flavour 278V1 D10-5120 01-Dec-2020 200 ml 02/01/2018
Asda Children’s Dry Cough Syrup Glycerol Blackcurrant Flavour 283W1 D10-5120 01-Feb-2021 200 ml 19/02/2018
Bell’s Healthcare Children’s Dry Cough Glycerin 0.75g/5ml Syrup 280V3 D10-4315 01-Dec-2020 200 ml 04/01/2018
Morrisons Children’s Dry Tickly Cough Glycerin 0.75g/5ml Oral Solution 282W1 D10-4325 01-Jan-2021 200 ml 30/01/2018
Numark Children’s Dry Cough 0.75 g/5 ml Oral Solution 280V1 D10-4042 01-Dec-2020 200 ml 04/01/2018
Numark Children’s Dry Cough 0.75 g/5 ml Oral Solution 288W1 D10-4042 01-Apr-2021 200 ml 27/04/2018
Sainsbury’s Children’s Dry Cough 0.75g/5ml Syrup 275V1 D10-0112 01-Sep-2020 200 ml 11/10/2017
Superdrug Children’s Dry Tickly Cough Glycerin 0.75 g/5 ml Oral Solution 280V2 D10-4695 01-Dec-2020 200 ml 04/01/2018
Superdrug Children’s Dry Tickly Cough Glycerin 0.75 g/5 ml Oral Solution 284W1 D10-4695 01-Mar-2021 200 ml 24/03/2018
Tesco Children’s Dry Cough Syrup 277V1 D10-4271 01-Oct-2020 200 ml 31/10/2017
Tesco Children’s Dry Cough Syrup 278V2 D10-4271 01-Dec-2020 200 ml 02/01/2018
Tesco Children’s Dry Cough Syrup 281W1 D10-4271 01-Jan-2021 200 ml 30/01/2018
Wilko Tickly Cough 0.75g/5ml Oral Solution 275V2 D10-0310 01-Sep-2020 200 ml 11/10/2017

Brief description of the problem

Bell, Sons & Co (Bells) is recalling 15 batches of the cough syrups listed above to patient-level as a precautionary measure due to a small number of reports of mould.

Advice for healthcare professionals

This Drug Alert is provided to healthcare professionals for information in case you receive any queries or ADRs relating to this issue.

This is a GSL product which has been sold from the retail shops Tesco, Asda, Wilkos, Sainsbury, Morrisons, Superdrug in the retailer’s livery and one pharmacy chain (Numark, in Numark livery). It has also been supplied in Bell, Sons & Co livery to Poundstretcher and to a number of wholesalers. All retailers and wholesale customers have been notified and stock is already being recalled at store level. Patients are being asked to return bottles from the above batches to the shop they bought it from.

At the time of writing the MHRA has not received any reports of ADRs relating to this issue.

The mould has been identified as Penicillium decumbens, Penicillium corylophilum and Penicillium brevicompactum. Although these moulds may be inactivated in the stomach, there is a low potential risk of systemic infection in younger or immunocompromised children, causing symptoms of infection such as fever.

Penicillium brevicompactum and Penicillium corylophilum can produce mycotoxins. Reactions to these mycotoxins are rare in reported literature but there is a low risk they could induce non-specific toxin reactions that could include rashes, breathing difficulties and Gastro-Intestinal (GI) symptoms.

There is also a low risk of allergen-mediated disease either through inhalation or ingestion of Penicillium antigens to occur, causing allergic symptoms.

Grocery stores and Numark Pharmacies

Please quarantine and return all stock of this product to your supplier as per the instructions provided by Bell, Sons & Co If your customers return stock to you, please return it to your supplier.

Patients and parents

It is important for people to check if they have any bottles from the batches of the blackcurrant cough syrups listed above. If they do, they should not take them or give them to others. They should return any bottles of the batches above to the shop or pharmacy they bought it from. The mould is not always visible so they should return any bottles of the cough syrups from the batches above even if they can’t see the mould.

Whilst the possibility of a reaction to the mould is low, if parents are concerned their child has had a reaction they should speak to their GP, pharmacist or other healthcare professional.

As with any medicine, we strongly encourage anyone to report any suspected side effects to the MHRA via the Yellow Card Scheme.

Class 4 medicines defect information: Bleo-Kyowa®, Powder for Solution for Injection, 15,000 IU PL 16508/0046

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Kyowa Kirin is advising caution in use for one lot of Bleo-Kyowa®, Powder for Solution for Injection, 15,000 IU following the detection of glass particles (EL (18) A/09)

Product information

MDR number

MDR 147-09/17

Company name

Kyowa Kirin

Product description

Bleo-Kyowa®, Powder for Solution for Injection, 15,000 IU (Bleomycin sulfate)

PL number

PL 16508/0046

Batch number Expiry date Pack size First distributed
Y7B290 Oct 2020 10 Jun 2018

Brief description of the problem

In April 2017, glass particles were detected in a batch of Bleo-Medac (bleomycin sulfate) from the same manufacturer.

Advice for healthcare professionals

While investigations are ongoing, additional measures should be adopted:

  • follow all the recommended steps for the preparation of Bleo-Kyowa in accordance with the Summary of Product Characteristics
  • carefully inspect the reconstituted product under a bright light
  • if particulate or glass matter is visible after reconstitution, do not administer the product to patients. Please retain the vial, quarantined safely away from other stock and notify the marketing authorisation holder
  • if there is no visible particulate matter after reconstitution, the use of a standard 5-micron (5 µm) filter needle to withdraw the reconstituted product from the vial prior to administration is recommended as glass particles may be difficult to see

Background

In April 2017, reports of glass particles in a batch of Bleo-Medac Powder for Solution for Injection, 15,000 IU, resulted in recall in some European countries. No recall action was necessary in the UK as the affected batch had not been distributed in the UK.

The marketing authorisation holder continues to investigate the root cause of this quality defect. To maintain continuity of supply in the UK, the marketing authorisation holder will distribute new batches of Bleo-Kyowa that meet current specifications.

Company contact information

Kyowa Kirin Medical Information

Tel: +44 (0)1896 664000

medinfo@kyowakirin.com

Merck sells consumer healthcare unit to P&G

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Germany’s Merck is selling its consumer health unit to Procter & Gamble for around for 3.4 billion Euros.

Merck said last year that is was mulling over the future of its consumer health division, and that a sale would help it execute its science and technology focused strategy.

“Consumer Health is a strong business that deserves the best possible opportunities for its future development. With P&G we have found a strong, highly recognised player who has the necessary scale to successfully drive the business going forward.”

Merck said sales from its consumer health unit grew organically by 6 percent between 2015 and 2017, “outpacing the consumer health market’s growth of approximately 4 percent over the same period”. The business pulled in new sales of around $911 million last year.

The transaction, which is expected to close by the end of the fourth quarter 2018, is subject to regulatory approvals and other customary closing conditions.

 

Source- Pharma Times

Diabetes test strips recalled in new alert

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Strips Recall

People with diabetes are advised to stop using and return specific lots of Accu-Chek Aviva and Accu-Chek Performa test strips following a recent recall by the manufacturer.

Accu-Chek Inform II test strips have also been recalled but are supplied in the UK by Roche for professional use only.

The test strips, commonly used by diabetics for blood glucose testing, may give increased strip error messages prior to dosing with blood and in some cases may give falsely high or low readings which may be hard to detect.

The Medicines and Healthcare products Regulatory Agency (MHRA) are urging users to check the lot numbers of their test strips against the lot numbers listed in the table below. More information can be found in this field safety notice. It is estimated that more than 260,000 packs have been affected.

If anyone finds they have test strips from the affected lots, they are advised to seek alternative testing methods and return affected lots to their pharmacy or shop where they will be offered a replacement.

It is also advised anyone with concerns about their blood glucose readings should discuss this with a healthcare professional.

Affected products

ACCU-CHEK AVIVA STRIPS (50s)

  • 497392
  • 497391
  • 496915
  • 496809
  • 496802
  • 496807

ACCU-CHEK AVIVA STRIPS (10s)

  • 497344
  • 497392

ACCU-CHEK PERFORMA STRIPS (10s)

  • 476597
  • 476646

Accu-Chek Inform II strips (professional use only)

  • 476614

Accu-Chek Performa Nano mmol Kit

(Please note the FSN only applies to the pack of Performa 10 test strips contained within the kit)

  • 10153116
  • 10153114
  • 10153115
  • 10153112
  • 10153111

Dan Howarth, Head of Care at Diabetes UK said:
It is incredibly important that people living with diabetes are able to rely on the technology that is designed to help them manage their blood sugar, so we’d strongly recommend that anyone using these test strips check their batch numbers and get replacement strips accordingly.

Inaccurate readings could mean you over- or under-dose with insulin, which in the short term can cause problems with hyper and hypoglycaemia. If you’re worried about your readings, we’d recommend speaking to your GP or a pharmacist as soon as possible.

Class 3 Medicines Recall: Latanoprost Timolol Eye drops

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FDC Pharma are recalling batch 087B087 due to an out of specification result for an unknown impurity during stability testing. (EL(18)A/08)

MDR number

MDR 076-04/18

Company name

FDC Pharma

Product description

Latanoprost / Timolol 50 micrograms/mL + 5mg/mL

Eye Drops, Solution

PL 35638/0004

Batch number/expiry

Batch Number Expiry Date Pack Size First Distribution
087B087 01/2019 1 x 2.5 mL 15/06/2017

Brief description of the problem

FDC Pharma are recalling the above batch due to an out of specification result for an unknown impurity during stability testing.

Advice for healthcare professionals

Stop dispensing the batch listed above. Quarantine and return all remaining stock of this batch to your supplier using the supplier’s approved process.

Advice for wholesalers and distributors

Refer to the instructions provided by FDC Pharma. Stop distributing the batch listed above. Quarantine and return all remaining stock of this batch to your supplier using the supplier’s approved process.

Valproate banned without the pregnancy prevention programme

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Valproate must no longer be prescribed to women or girls of childbearing potential unless they are on the pregnancy prevention programme (PPP).

To protect public health, the Medicines and Healthcare products Regulatory Agency (MHRA) has changed the licence for valproate medicines (Epilim, Depakote and generic brands). Valproate must no longer be prescribed to women or girls of childbearing potential unless they are on the pregnancy prevention programme (PPP).

Valproate is a treatment for epilepsy and bipolar disorder. Children born to women who take valproate during pregnancy are at significant risk of birth defects and persistent developmental disorders. If valproate is taken during pregnancy, up to 4 in 10 babies are at risk of developmental disorders, and approximately 1 in 10 are at risk of birth defects.

Healthcare professionals who seek to prescribe valproate to their female patients must make sure they are enrolled in the PPP. This includes the completion of a signed risk acknowledgement form when their treatment is reviewed by a specialist, at least annually.

All women and girls who are prescribed valproate should contact their GP and arrange to have their treatment reviewed. No woman or girl should stop taking valproate without medical advice.

These regulatory changes will be further supported in the upcoming months by:

smaller pack sizes to encourage monthly prescribing
a pictogram/warning image on valproate labelling
These new regulatory measures are being supported across the NHS with other authorities also making changes – such as new GP system computer alerts – to make sure changes in prescribing behaviour take place promptly. NHS Digital has worked with GP systems suppliers to provide a search and audit function to identify women and girls on valproate as well as updating valproate prescribing alerts. A letter will be sent to all relevant healthcare professionals in the coming weeks outlining the new requirements and providing updated educational materials.

In parallel, the National Institute for Health and Care Excellence (NICE) is amending its guidelines where valproate is mentioned, to reflect the new regulatory position. NICE has also begun work on a full update of its guideline on epilepsy. This will specifically focus on areas where valproate is currently regarded as the drug of choice and where this conflicts with the new position.

Working together, across the health sector, these measures will help reduce the number of pregnancies exposed to valproate medicines to an absolute minimum and will make sure all women and girls of childbearing potential are aware of the risks.

Since it was introduced in 1974, the information provided with valproate included a warning about the possible risk of birth defects. As with all medicines, the safety of valproate has been kept under constant review and as new data have become available, and the magnitude and the nature of the risks were better understood, warnings were updated – resulting in this most recent regulatory change.

Dr June Raine, director of MHRA’s Vigilance and Risk Management of Medicines Division said:

Patient safety is our highest priority. We are committed to making sure women and girls are aware of the very real risks of taking valproate during pregnancy. However, we also know it is vitally important women don’t stop taking valproate without first discussing it with their doctor.

This regulatory position has been developed through close collaboration with professional bodies, health system organisations, and patient and campaign groups.

I would like to particularly thank the families involved in the Valproate Stakeholder Network who have shared their experiences and expertise with us. Their support will help keep future generations of children safe.

Health Minister Lord O’Shaughnessy said:

Our priority is always patients’ safety, so I welcome this decision to take strong actions to protect women and children.

The focus will now be on explaining these changes to GPs and clinicians so they in turn can advise patients.

Professor Mark Baker, director of the Centre for Guidelines at NICE, said:

NICE welcomes restricting the use of valproate in women of childbearing potential.

It’s important that everyone affected by these changes is made aware of them as soon as possible. We have therefore taken immediate steps to amend our guidelines on the diagnosis and management of epilepsies, the assessment and management of bipolar disorder, depression in adults, and antenatal and postnatal mental health to reflect this important change to the drug’s licence.

We will use our communications networks to highlight the changes, both to healthcare professionals and to patients, to help ensure that the number of children exposed to valproate through their mother during pregnancy is kept to an absolute minimum.

Nic Fox, director of Primary and Social Care Technology at NHS Digital said:

This is a good example of how IT systems can support important issues affecting public health. We have been working closely with the MHRA and GP system suppliers to ensure clinicians in primary care are informed of the risks of prescribing sodium valproate to certain patients.

All GP systems have alerts applied and we are continuing to work with some of the suppliers to ensure these high visibility alerts are consistent across primary care. These alerts ensure that GPs are prompted at the time of prescribing.

We have also worked with community pharmacy dispensing system suppliers to ensure that the alerts are also shown when prescriptions are dispensed. This includes changes to prescription labels so that patients are made aware of the risks and the need for reliable contraceptive precautions. We will continue to work with supplier partners in evolving system to maximise safety and minimise burden on clinicians and patients as guidance evolves.

Matthew Jolly, National Clinical Director for maternity and women’s health at NHS England, said:

Stronger regulation over the use of valproate is welcome and will help ensure women get the advice and care they need. It is important pregnant women discuss their medication with their doctor and crucially do not stop taking it before seeking advice.

Mr Edward Morris, vice president for clinical quality at the Royal College of Obstetricians and Gynaecologists, said:

We welcome this action to reduce the risk of physical and developmental problems in children born to mothers who have taken valproate during pregnancy. Our clinical guideline on the management of epilepsy in pregnancy recommends that exposure to sodium valproate and other anti-epileptic drugs should be minimised by changing the medication prior to conception, as recommended by an epilepsy specialist after a careful evaluation of the potential risks and benefits.

It’s important to note that stopping medication for long-term conditions completely or altering the dose can pose a serious risk to both mother and baby. Women are advised to seek advice from their GP and/or specialist team before conception or as soon as they are aware that they are pregnant. For women with epilepsy, the lowest effective dose of the most appropriate anti-epileptic drug should be prescribed and they should be looked after by a specialist team throughout pregnancy.

Professor Helen Stokes-Lampard, chair of the Royal College of GPs, said:

GPs are acutely aware of the risks associated with prescribing sodium valproate to women of childbearing age and we welcome this change in legislation as a logical way forward to help ensure our patients’ safety. However, any patients currently taking sodium valproate should not stop doing so without seeking expert medical advice.

As a general rule, it is important that patients read and take heed of warnings on the packets of any medication they are taking – and that any woman on long-term medication speaks to their GP if they are planning to have a baby.

Carol Long, chief executive of Young Epilepsy, said:

Young Epilepsy welcomes the MHRA’s strengthened regulatory position for women of childbearing potential, who are diagnosed with epilepsy and prescribed sodium valproate. In ensuring such women receiving a Pregnancy Protection Plan (PPP), they will have greater knowledge in realising the potential risks taking the drug has to the unborn child.

It is vital that women who may be planning to have a family receive the right advice at the right time; to prevent their unborn babies being put at risk.

Sodium valproate can provide life-changing support for many young people with epilepsy. It is the third most-prescribed anti-epilepsy medication, however, the percentage of women who do not know the risks of taking the drug during pregnancy is far too high. That information must be made clearer, and medical professionals must be given more support to understand and be proactive in flagging the risks. Women must feel more empowered to discuss the issue with their epilepsy specialist, so that they can make a more informed decision about their future.

Simon Wigglesworth, deputy chief executive of Epilepsy Action, said:

We welcome the revised measures which reflect the seriousness of the risks to the unborn children of women with epilepsy during pregnancy. Despite previous interventions, we know there are still far too many women who haven’t been made aware of the potential risks of taking sodium valproate in pregnancy.

It is vitally important that healthcare professionals ensure that all women with epilepsy taking sodium valproate are reviewed in line with the new guidelines. We are working closely with the MHRA on the implementation of these new guidelines and will be looking to see if meaningful progress will be made in avoiding life-changing harm to children born to women with epilepsy.

Clare Pelham, chief executive of Epilepsy Society, said:

The most important change today is that every woman and girl of childbearing age who has been prescribed sodium valproate will be able to see her doctor every year to discuss the risks of this drug to an unborn baby. She will leave the discussion with an important written reminder of the risks if sodium valproate is taken during pregnancy. This means that she will be able to make informed choices about whether to plan a pregnancy and her future medical treatment.

It has taken many years to achieve these simple, straightforward and inexpensive healthcare improvements that will prevent babies being born with avoidable disabilities. All credit to the brave women who have campaigned for decades. And to Jeremy Hunt for acting on that campaign and insisting the NHS must now learn from its failure to listen and act sooner in response to the concerns raised over many years and during many governments. At Epilepsy Society we shall be diligently monitoring the implementation on the ground in order to confirm that it is robust and effective.

Stephen Buckley, head of Information at Mind, the mental health charity, said:

We welcome the new rules around prescribing valproate to women of childbearing age. It is essential the information about the changes reaches both the public and professionals, and that any women taking valproate are properly supported to come off the medication safely. Mind’s website has updated information about what these changes mean – visit mind.org.uk for details.

Emma Friedmann, campaign director of #FACSaware, said:

FACSaware are absolutely delighted with the new measures as this will enable women to have an informed choice.

We look forward to continuing our work with the MHRA to promote the importance of the Central Alerting System and the Yellow Card ADR reporting scheme.

We are confident that fewer children will be born with this avoidable syndrome. By working with stakeholders we are definitely achieving our objectives.

Carol Lapidge & Susan Cole, OACS (Organisation for Anti-Convulsant Syndrome) Charity, said:

OACS Charity welcomes the prevention measures agreed by MHRA who have consulted with us alongside other campaign groups over the past two years. Since January 2016 OACS Charity has attended every meeting of the Valproate Stakeholder’s Network and we are appreciative that the MHRA has developed this progressive forum for discussion.

Next year OACS will be celebrating 20 years supporting and representing families affected by fetal valproate syndrome and we are pleased that the MHRA has developed this progressive forum for discussion.

Their work with stakeholders has resulted in inclusive and constructive engagement with groups across the UK health, science and digital sectors alongside patient groups. This has been a difficult but hugely constructive journey.

We believe that this process, led by June Raine, will pave the way for other groups who have been adversely affected by medicines in the past.

If you have been affected by sodium valproate please see our website oacscharity.org.

Janet Williams & Emma Murphy, INFACT, said:

INFACT welcome the changes made to the licence for Valproate and are pleased and very proud to have instigated and helped drive this forward following 6 years campaigning at Parliament for those changes.

It is important that all women prescribed Valproate are made aware of the risks when taken in pregnancy in order to safeguard their future children from disabilities, and INFACT applaud the decision made by the MHRA to ensure that risk is minimal.

Karen Keely, chairperson of OACS Ireland, said:

OACS Ireland welcomes the new regulatory measures by MHRA Epilim (Valproate) UK Toolkit. Women and men were prescribed this drug as far back as 1973 in the UK with many children harmed worldwide.

OACS Ireland welcomes the MHRA efforts to make changes to the way valproate is prescribed to prevent further harm. They brought their concerns to the attention of the EMA and therefore to all EU Nations including Ireland. By ensuring that the Epilim (Valproate) toolkit is securely put in place alongside Pregnancy Prevention Program (PPP) we hope to ensure this is followed by all.

We have been working with MHRA for many years now and hope to assist them with their work as much as possible by ensuring the valproate toolkit is followed. We hope that the new guidance will be followed by all. As part of the stakeholder’s network group run by the MHRA which has resulted in inclusive and constructive engagement with groups across the UK and Ireland’s health, science and digital sectors alongside patient groups. Although this process has been a difficult it has been hugely constructive.

Without the UK MHRA contributions to the EMA many mothers would not have known the risks of this drug.

On behalf of the Association of British Neurologists (ABN) by Professor Mary M Reilly, President, and Professor Sanjay Sisodiya, Chair of the ABN Epilepsy Advisory Group, said:

The ABN welcomes these important new measures. It is vital that all neurologists are aware of the changes to the licensing of valproate. We will disseminate information around the new measures to our membership through our publications, website and bulletins. We will also include links to a variety of resources and organisations, including support groups, and remind our membership about the Epilepsy and Pregnancy Register.

It cannot be stressed enough that no women should stop taking this medication without medical advice.

Dr Angelika Wieck, Royal College of Psychiatrists Perinatal Faculty and Consultant Psychiatrist, Central Manchester University Hospital, said:

Valproate can cause harm to unborn children so banning its use in women with mental disorder who are pregnant, or could get pregnant, is welcome. It cannot be stressed enough that no women should stop taking this medication without medical advice.

Managing mental health is particularly important for women who are pregnant or plan to get pregnant. It is essential that all women are better informed about the risks of Valproate to unborn children and that any use of this drug in pregnancy will be monitored.

RCPsych will work with the MHRA and other Government bodies, the Royal Colleges of General Practitioners, Physicians, Obstetricians and Gynaecologists and the Royal Pharmaceutical Society to implement changes in clinical practice and support affected women.

Rachel Scanlan, professional advisor at the Royal College of Midwives, said:

These are very welcome measures that will enable midwives to advise and support women about this issue. We are actively putting this information out to our members including on social media and via the RCM’s website so that our members are informed about this important update. We have also updated our online learning package on epilepsy and pregnancy to reflect these changes.

Professor Ash Soni, president of the Royal Pharmaceutical Society, said:

The Royal Pharmaceutical Society fully supports these new measures to ensure women understand the risks of taking sodium valproate during pregnancy. They must get the right information from health professionals in order to make informed choices about their health and parenting options. Valproate is an effective medicine and women should never suddenly stop taking it without talking to a health professional. Pharmacists are ideally placed to give information and support when providing sodium valproate and are committed to reducing harm from medicines, enabling women to make the choices that are right for them.

Dr Asha Kasliwal, president of the Faculty of Sexual and Reproductive Healthcare (FSRH), said:

FSRH welcomes the new regulatory measures on sodium valproate medicines introduced by the MHRA. Evidence is clear that children born to women who take valproate during pregnancy are at a significant risk of birth defects and developmental disorders.

Some of these drugs can affect how well some contraceptive methods work. However, women and girls who need these life-changing medications do not have to be left at risk for unplanned pregnancies. Our 2017 clinical guidance on drug interactions with hormonal contraception recommends that women and girls taking sodium valproate use highly-effective methods of contraception to avoid an unplanned pregnancy, both during treatment and for the recommended timeframe after discontinuation.

Methods of contraception which are considered highly effective in this context include long-acting reversible contraceptives (LARCs) such as the copper IUD, levonorgestrel intrauterine system (LNG-IUS), the progestogen-only implant (IMP) and sterilisation. Women should seek advice from a specialist, who will carry out a pregnancy risk assessment and provide evidence-based advice on the most suitable method for them.

In February this year, FSRH issued a clinical statement on contraception for women using known teratogenic drugs such as valproate, which is intended to support clinicians in providing high quality and consistent contraceptive advice. FSRH will keep working with its members to ensure they are aware of the MHRA decision and can advise women accordingly.

Merck sells consumer healthcare unit to P&G

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Germany’s Merck is selling its consumer health unit to Procter & Gamble for around for 3.4 billion Euros.

Merck said last year that is was mulling over the future of its consumer health division, and that a sale would help it execute its science and technology focused strategy.

Stefan Oschmann, chairman of the executive board and Merck’s chief executive, said the move “is a clear demonstration of our continued commitment to actively shape our portfolio as a leading science and technology company.”

“Consumer Health is a strong business that deserves the best possible opportunities for its future development. With P&G we have found a strong, highly recognised player who has the necessary scale to successfully drive the business going forward.”

Merck said sales from its consumer health unit grew organically by 6 percent between 2015 and 2017, “outpacing the consumer health market’s growth of approximately 4 percent over the same period”. The business pulled in new sales of around $911 million last year.

“We like the steady, broad-based growth of the OTC healthcare market and are pleased to add Merck’s Consumer Health portfolio and people to the P&G family,” added David Taylor, P&G Chairman of the board, president and chief executive.

The transaction, which is expected to close by the end of the fourth quarter 2018, is subject to regulatory approvals and other customary closing conditions.

As part of the transaction, around 3,300 employees are expected to transition to P&G, subject to prior works council consultation where required.

 

Source – Pharma Times