Latisse For Longer, Fuller And Darker Eyelashes

A member of the public complained to the MHRA about a poster advertisement for
Latisse, which was displayed in the window of Michael John Salon.

LATISSE® is a prescription treatment for hypotrichosis (inadequate or not enough lashes) to grow eyelashes longer, fuller, darker.

Agrippal suspension for injection in pre-filled syringe

Class 2 Drug Alert (Action Required Within 48 Hours): Novartis Vaccines and Diagnostics S.r.l.  - Agrippal suspension for injection in pre-filled syringe - Influenza Vaccine - EL (12) A/34

Novartis Vaccines and Diagnostics S.r.l.

Agrippal suspension for injection in pre-filled syringe(Influenza Vaccine)PL 13767/0004


Summary:
At the request of MHRA, Novartis Vaccines and Diagnostics S.r.l. is executing a precautionary recall of Agrippal suspension for injection in pre-filled syringes. Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. Primary care trusts are asked to forward this to relevant clinics and to general practitioners and community pharmacists for information.

Batch Number	Expiry Date	Pack Size	First Distributed
126201A	31 May 2013	10 x pre-filled syringes	9 Oct 2012
126102	31 May 2013	10 x pre-filled syringes	17 Oct 2012

Based on the information available, there is no evidence of any new safety concerns or of any impact on efficacy. No adverse reactions which may be associated with this issue have been reported to Novartis in connection with these batches. Those who have had a flu vaccine from these batches should have no cause for concern and there is no need for revaccination.

Remaining stocks of the affected batches should be quarantined and returned to the original supplier for credit. For enquiries relating to stock returns please contact Novartis Vaccines Customer Services on 08457 451 500

For medical information enquiries, please telephone Novartis Vaccines Medical Information on 01748 828 816.

Risks of Liver Problems With Black Cohash

The MHRA have again reminded public about the risk of liver problems with the herbal remedy Black Cohosh – a product commonly used to relieve menopausal symptoms.

The reminder follows a serious case of liver failure resulting in a liver transplant suspected to have been caused by a herbal product containing Black Cohosh. The investigation of this case and of the product involved is ongoing.To date, the MHRA has received 53 reports of adverse reactions suspected to be associated with the use of Black Cohosh products through its medicines safety monitoring reporting system, the Yellow Card Scheme. The majority of these reports (36) have involved liver problems including abnormal liver function, jaundice and hepatitis.

Black Cohosh products are available for general sale in pharmacies, supermarkets and health food shops. Currently, there are both authorised (registered under the Traditional Herbal Registration (THR) scheme) and unlicensed products legally on the market.

Since 2006, the MHRA has asked all manufacturers of Black Cohosh products to ensure that an appropriate warning about possible liver problems is included on the label. The MHRA recently became aware that some unlicensed products containing Black Cohosh may not have this warning and we are issuing a reminder to the sector of the need to carry appropriate warnings on their product labelling.

The MHRA always recommends that registered herbal products are used. Registered products can be identified by the Traditional Herbal Registration (THR) registration number or logo on their packaging. These products have been assessed and quality checked to ensure that they are acceptably safe to use and are accompanied by a leaflet with information on how to use the product with possible side effects listed.

The unlicensed products do not have the THR registration or logo number and have not been assessed for quality.  

Richard Woodfield, the MHRA’s Head of Herbal Policy, said: “It is important that people with a history of liver problems do not use Black Cohosh herbal products

“Other people who wish to use Black Cohosh herbal products should check for the traditional herbal registration (THR) number on the packaging indicating that it has been made to assured standards. If the product does not have a THR registration number there would have been no assessment as to the safety or quality of the product.

“Reading the patient information leaflet ensures that you are aware of the correct way to take a medicine, the potential side effects as well as any possible interactions with other medication you may be taking. Unlicensed herbal products may have incomplete, inaccurate or no safety information and can mean you are gambling with your health, especially if you take these products without consulting a GP or qualified healthcare professional.”

http://www.mhra.gov.uk/home/groups/es-herbal/documents/websiteresources/con2024279.pdf

MHRA wins High Court case on wholesaler dealing

The case, relating to Blackbay Ventures Ltd, concerned whether or not regulations allowed for those that operate both as registered pharmacies and licensed wholesale dealers to obtain medicinal products from pharmacies which do not hold a licence.

The judge ruled that it is unlawful for the holder of a wholesale dealer’s licence to obtain supplies from a person who does not have a licence to distribute medicinal products. He also said that it is no defence for the holder of the wholesale dealer’s licence to claim he was acting as a pharmacy when he obtained the products from a person who does not have a licence to distribute.

The core of the judgment is that in order to comply with legislation holders of wholesale dealer’s licences (even if they also operate as a pharmacy) must only obtain medicines from another wholesale dealer licence holder or from a licensed manufacturer. 

http://www.mhra.gov.uk/home/groups/comms-po/documents/news/con197923.pdf

New rules on importing active pharmaceutical ingredients into the European Union

The European Commission has published an information leaflet on the new rules on
importing active pharmaceutical ingredients into the European Union.

http://ec.europa.eu/health/files/documents/active_pharmaceutical_ingredients_leaflet_en.pdf

Typhoid Vaccine

Class 2 Drug Alert (Action Within 48 hours): Sanofi Pasteur MSD Limited - Typhim Vi - Typhoid Polysaccharide Vaccine - EL (12)A/33

The MHRA today issued a drug alert to healthcare professionals advising them that
the manufacturer Sanofi Pasteur MSD has recalled 16 batches of their typhoid
vaccine, Typhim Vi.

he Medicines and Healthcare products Regulatory Agency (MHRA) today issued a drug alert to healthcare professionals advising them that the manufacturer Sanofi Pasteur MSD has recalled 16 batches of their typhoid vaccine, Typhim Vi.

This recall is due to concerns about the effectiveness of the vaccine in some syringes distributed from 7 January 2011 following filling problems in the manufacturing process. Therefore some patients who have been vaccinated with Typhim Vi may not be fully protected against the disease.

If you received this vaccine and have recently returned from abroad, and are unwell, you should contact your doctor.

Vaccine is still available and the Department of Health is working with manufacturers to help ensure that current supply problems are resolved as soon as possible.

MHRA Head of Defective Medicines Report Centre, Ian Holloway said: “There are no concerns over the safety of this vaccine but the recall has taken place because the vaccine may not be as effective as it should be.

“Anyone who has been to a typhoid region of the world and has a fever, abdominal pain and vomiting should contact a healthcare professional. They can also give them information and advice about minimising the risk of getting typhoid.”

Typhim Vi batches being recalled are in this document:
http://www.mhra.gov.uk/home/groups/is-md/documents/websiteresources/con192144.pdf

For medical information enquiries, please telephone  0800 7311654 or fax to 01628 635072.

Counterfeit And Unlicensed Drugs

MHRA played a vital role in $6.5 million drugs bust and stopping spam emails.

More than $6.5 million worth of counterfeit and unlicensed medicines have been seized across the globe as part of a week-long international crackdown on the illicit internet trade in pharmaceuticals.

http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON189211

Pharmaceutical Wholesaler In UK Sept 2012

Register of Licensed Wholesale Dealer Sites (Human Veterinary and Combined Sites) 
September 2012

http://www.mhra.gov.uk/home/groups/is-lic/documents/publication/con2025604.pdf

Risks Of Antipsychotic Drugs

Learning package on Antipsychotic drugs launched

The MHRA have today launched a learning module on antipsychotic drugs for clinical practitioners. The self-directed learning package outlines the key risks of this widely prescribed class of medicines.

Antipsychotics learning module

About this learning module

Antipsychotics are prescribed very widely, mainly for psychosis, but also for other indications. This module identifies the most important hazards of antipsychotics and informs on actions that health professionals can take in order to anticipate, minimise and manage the risks.

Who should complete this module

This training module is for medical, nursing and pharmaceutical professions. It is especially suitable for pharmacists, general practitioners and those starting out in psychiatry. Health professionals who are established in practice will also find the module a helpful refresher.

Learning objectives

Used with summaries of product characteristics and authoritative guidelines on the clinical use of antipsychotics, this module will help to maximise the benefits of antipsychotics.

On completion of the module you will be able to:
• recognise any antipsychotic drugs you encounter and how the drugs are classified
• list important risks of antipsychotic drugs in general
• outline factors that contribute to the risks of antipsychotics and how the risks can be reduced
• identify important drug interactions of antipsychotics
• outline the risks of special uses of antipsychotics (eg in the elderly with dementia, use of immediate-acting and prolonged-action parenteral antipsychotics and of clozapine) and how these risks can be minimised

Time required

It will take you about 3.5 hours to complete the module. It doesn’t have to be done in one sitting. You will need about 30 minutes to answer the multiple-choice questions and to check your answers against the question feedback we have provided.

Learn it all here:
http://www.mhra.gov.uk/ConferencesLearningCentre/LearningCentre/Medicineslearningmodules/Antipsychoticslearningmodule/CON155606

Fake Prescription Medicine

Press Release: Three Essex men sentenced for sale and manufacture of controlled drugs and fake prescription medicines.

Following an investigation into the website www.staymassive.com and a number of other websites by the Medicines and Healthcare products Regulatory Agency (MHRA), three Southend-on-Sea men were sentenced yesterday at Southend Crown Court on a number of counts in relation to the possession and supply of controlled drugs and prescription only medicines online.

Tubilux Infected Eyes Eye Drops

Class 3 Drug Alert (Action Required Within 5 Days): Bausch & Lomb (UK) Ltd - Tubilux Infected Eyes Eye Drops - Chloroamphenicl 0.5% w/v - EL (12) A/31

Baush & Lomb (UK) Ltd is recalling a batch of Tubilux Infected Eyes Eye Drops because the cartons have inadvertently been packed with the Patient Information Leaflet for Chloroamphenicol 1% w/w Eye Ointment.

Pfizer's Diflucan powder for oral suspension (10 mg/ml and 40 mg/ml)

Class 4 Drug Alert (caution in use): Diflucan powder for oral suspension (10mg/ml and 40mg/ml) -Pfizer Limited - EL (12)A/31

Pfizer Limited has recently amended the labels and Patient Information Leaflet (PIL) for the above products. They have informed the MHRA that there may be some confusion resulting from the new packaging. To ensure continuity of supply, distribution of affected stock will continue and it will be necessary to release further batches.
Steps are being taken to remedy this situation as quickly as possible, but it maybe several months before the issue is resolved.

Super Soraderm

Press release by MHRA on 14 September 2012

A Walsall man was today sentenced to nine months imprisonment, suspended for two years, on two counts of the sale, supply and possession of an unlicensed cream named ‘Super Soraderm’. The cream was marketed for use on children but it could cause some serious skin diseases.

Mohammed Rashid, aged 54, a director of a limited company, M&T Supermarkets, which has premises at 147 – 153 Caldmore Road, Wallsall, was also ordered to 200 hours of community service on each of the counts to run concurrently.

Mr Rashid was selling ‘Super Soraderm’ for £12.99 a tub and sold approximately 50 tubs every four weeks. M & T Supermarkets were fined a total of £20,000. Both were ordered to share the payment of costs of £6,944.00.

It was brought to the Medicines and Healthcare products Regulatory Agency’s (MHRA) attention by Birmingham Children’s hospital when children had become ill after parents had used ‘Super Soradem’ which contained the prescription only medicine Clobetasol Propionate - a very strong steroid that should only be prescribed by a doctor and applied sparingly.

One case involved a three-year-old boy who had developed viral warts on his body and another case involved an eight-year-old boy who had to be referred to an urgent eye clinic due to severe eczema round the eyes as a result of using the cream.

Nimo Ahmed, MHRA Acting Head of Enforcement, said “We strongly advise anyone using this product to stop immediately. Steroid based creams should only be used under the supervision of a medical professional. This is a clear example of the blatant disregard for people’s health that some will go to in order to make money.”

Professor Celia Moss, a dermatology consultant at Birmingham Children’s Hospital, who has seen first-hand the damage such strong steroids can cause to young skin, after children were treated for skin and eye problems as a result of using the cream said “People need to be aware that products being sold as ‘miracle’ treatments could contain powerful steroids. These are steroids that should only be used under medical supervision.”

AllerTek 10mg Tablets - Cetirizine dihydrochloride

Class 3 Drug Alert (Action required within five days): AllerTek 10mg Tablets - Teva UK Limited - EL (12) A/30

Teva UK Limited is recalling all remaining stock of AllerTek 10mg Tablets (cetirizine dihydrocholoride). This is because the results of dissolution tests carried out during routine stability studies did not comply with the required specification.

Diabetics to Check Hypurin Porcine Isophane Insulin Cartridges

Class 2 Drug Alert (Action required within 48 hours): Hypurin Porcine Insulin 100 IU/ml Cartridges - Wockhardt UK Ltd - EL (12) A/29

Diabetes patients are urged to check Hypurin Porcine Isophane Insulin Cartridges after packaging error identified.

Wockhardt UK Ltd has informed the Medicines and Healthcare products Regulatory Agency (MHRA) that they have received a single report of a blister from the above batch, containing 5 correctly labelled Hypurin Porcine Neutral Insulin 100 IU/ml cartridges, being inadvertently packed in a carton for Hypurin Porcine Isophane Insulin 100 IU/ml. 

Affected cartons should be quarantined and immediately reported to for return and credit or replacement to be arranged. 

Pharmacists are asked to contact patients who may have stocks of this Isophane Insulin.

The Medicinines and Healthcare products Regulatory Agency (MHRA) is today urging those with diabetes using Hypurin Porcine Isophane insulin cartridges to check their medication 

MHRA repeats warning about unlicensed tanning drug malanotan

The MHRA has repeated its warning not to use the unlicensed tanning drug melanotan.

An MHRA spokesperson said:

“We are warning people not to use this product. Melanotan is not licensed for use in the UK and there is no information about its safety. Side effects from its use could be extremely serious.

"If you have used Melanotan do not use it again and if you have any health concerns you should seek advice from your doctor.

“The sale of Melanotan is a criminal offence and we advise people who have bought this product to contact us at 020 3080 6330 or at casereferrals@mhra.gsi.gov.uk”

Cymeve 500mg Powder for Infusion

Class 2 Drug Alert (Action Required Within 48 Hours)

Cymevene 500mg Powder for Infusion - Roche Products Limited - EL (12)A/28

Roche Products Limited is recalling the above batch because there have been a small number of reports of damaged vials and there are concerns that sterility assurance cannot be guaranteed. 

Where appropriate, the product should be returned to the original supplier. Where stock was purchased from Roche Products Limited, complete stock return form and fax it back. Roche will arrange collection.

Wigmore Medical Limited

Wholesale Dealer's Licence suspended

Wigmore Medical Limited's Wholesale Dealer's licence (WL 8698) was suspended by MHRA on 16 August 2012 till 16 November 2012.

Medical Imports

Wholesale Dealer's Licence in UK

Medical Imports Wholesale Dealer's Licence (WL 20384) was suspended by MHRA from 2 August 2012 till 02 February 2013.

Evotrox Oral Solution 25, 250, 100mcg per 5ml

Class 2 Drug Alert (Action Required Within 48 Hours): Evotrox 25, 50 and 100 micrograms/5ml Oral Solution by Kappin Limited - EL (12) A/27

Kappin Limited is recalling all remaining stock of the above products because variable stability data do not give an assurance of the product product quality. Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. Primary care trusts are asked to forward this to relevant clinics and to general practioners and community pharmacists for information.

DMAA Containing Products

28 August 2012

UK's Medicines and Healthcare products Regulatory Agency (MHRA) has ruled that the popular DMAA containing sports supplement Jack3D is an unlicensed medicinal product and that it and all other DMAA containing products need to be removed from the UK market amid concerns of potential risks to public safety.

Epistatus, Midazolam 10mg in 1ml Buccal Liquid

Class 4 Drug Alert:
Midazolam 10mg in 1ml Buccal Liquid x 5ml (M11) - Unlicensed medicine made under Manufacturer's Specials Licence MS 124 - Special Product - EL (12) A/26

Summary:
Special Products Ltd have now made a final change to the syring, within the Epistatus packs, to one without a luer tip. The packs containing the new syringe will be distributed from September 2012.

Zovirax Suspension 200mg/5ml

Class 2 Drug Alert (Action Within 48 hours): Zovirax Suspension 200mg/5ml - GlaxoSmithKline UK - EL (12) A/25

GlaxoSmithKline UK are recalling multiple batches of 125ml bottles of the above product. This is due to incorrect dosing instructions on the Patient Information Leaflet advising patients to take half the recommended dose.

Class 2 Drug Alert for Paracetamol 500mg Tablets

Class 2 Drug Alert (Action Within 48 Hours) Paracetamol Tablets 500mg  - Actavis UK Ltd

Actavis UK Ltd are recalling all remaining packed stocks of 500mg Paracetamol Tablets to wholesaler, Pharmacy and Clinic level. This is due to the use of incorrect blister foil which fails to meet the specification for child resistance.

Class 4 Drug Alert: NuTRIflex Lipid products / Nutriflex Omega products - B.Braun Medical Ltd - EL (12)A/23

For several months NuTRIflex Lipid products have required additional filtration
during administration. Nutriflex Omega products were recalled earlier, due to
potential particulate formation, and marketing was temporarily discontinued. 

B.Braun Medical Ltd have advised the MHRA that the problem with particulates in all the
products listed above has now been resolved.

May 2012 Drug Alerts

• 31 May 2012 | 

  Class 4 Drug Alert: Pharmathen S.A. - Matever 100mg/ml concentrate for solution for infusion - EL (12)A/22

  Pharmathen SA have informed us that there is an error in the healthcare professional user text, at the end of the patient information leaflet, which affects the single batch listed above.

• 30 May 2012 |

  Class 3 Drug Alert (Action within five days): Martindale Pharmaceuticals Ltd - Cyclizine Lactate Injection 50mg/ 1ml ampoules - EL (12)A/21

  Martindale Pharmaceuticals Ltd is recalling all remaining unexpired ampoules of Cyclizine Lactate Injection 50mg/ 1ml  ampoules, which has been discontinued as a precautionary measure. Recipients are requested to return any remaining stock to their normal supplier for credit.

• 23 May 2012 | 

  Class 2 Drug Alert (Medicines recall): Lincoln Medical Limited - Anapen 500mcg, 300mcg and Junior 150mcg/0.3ml solution for injection in a pre-filled syringe - EL (12)A/20

  Lincoln Medical Limited is recalling all unexpired units of Anapen 500mcg, 300mcg and Junior 150 mcg 0.3ml solution for injection in a pre-filled syringe to patient level as a precaution.



• 17 May 2012 | 

  Class 3 Drug Alert (Action Within 5 days): Kappin Limited - Fulsovin 125mg/5ml Oral Suspension - EL (12)A/19

  Kappin Limited is recalling all remaining stock of this product because stability testing has indicated that the product will not comply with the required specifications for the duration of the shelf-life.

• 09 May 2012 | 

  Class 3 Drug Alert (Action Within 5 days): Teva UK Limited - Levothyroxine 100mcg Tablets in Teva UK and Numark liveries - EL(12)A/18

• Teva UK Limited is recalling all remaining in-date stock of Levothyroxine 100mcg tablets in Teva UK and Numark liveries.



• 03 May 2012 | 

  Class 4 Drug Alert: Priadel Liquid (Lithium Citrate 520mg/5ml equivalent to Lithium Carbonate 204mg/5ml) - Sanofi - EL (12)A/17

  Sanofi has informed the MHRA that they have received several reports that Priadel Liquid appears cloudy rather than clear. A detailed investigation has been carried out and this has shown that the cloudiness is not due to microbial contamination. The root cause has been attributed to a change of source for one of the excipients, Xanthan gum.