25/05/2012
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Product recall (patient level): All batches
of Anapen® and Anapen Junior® (adrenaline) injections
The MHRA has issued a Class 2 Drug Alert (patient level), recalling all stocks of Anapen® (adrenaline 500 micrograms and 300 micrograms) and Anapen Junior® (adrenaline 150 micrograms) injectors. Patients prescribed these products should be contacted and advised to make an appointment with their GP or clinic to discuss switching to an alternative product as soon as possible.
This is a precautionary recall after the company has identified a potential problem with the delivery time and delivery volume following activation of the autoinjector. In the worst case scenario, this could result in a failure to deliver any drug in an emergency situation. So far, the company has not received any defect or adverse drug reactions reports associated with this issue.
A MHRA press release has also been issued, advising people with severe allergies to see their GP or clinic as soon as possible to discuss alternative products after the recall of the Anapen® (adrenaline) injector. People with these injectors are advised to continue using their Anapen injectors until they can discuss using alternative products with their GP or clinic.
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24/05/2012
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Oral tacrolimus products should be prescribed by brand name
A letter has been issued to healthcare professionals by the Chairman of the Commission for Human Medicines regarding branded prescribing of tacrolimus products. Inadvertent switching of tacrolimus products has been associated with reports of toxicity and graft rejection. Recommendations are as follows:
- Tacroliumus products should be prescribed by brand name only. When prescriptions have previously been written using the generic name, the brand on which the patient is stabilised should be established to ensure that the patient is supplied with the same product.
- If a prescriber intends to switch between any tacrolimus brands, careful medical supervision and therapeutic monitoring are required.
- Pharmacists should always dispense the exact brand
prescribed. They should contact the prescriber if the prescription is not clear to ensure the appropriate medicine is dispensed.
- Patients should be advised to take careful note of the name of their usual tacrolimus brand and should check with their doctor or pharmacist if they receive a different brand or if they have any other questions about the prescription, e.g. about the dose.
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17/02/2012
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Licence for Teva levothyroxine 100 microgram tablets suspended
The MHRA have suspended the licence of levothyroxine 100 microgram tablets manufactured by Teva. The licence suspension is due to manufacturing difficulties and concerns that this product may not be interchangeable with other levothyroxine 100 microgram tablets. An MHRA investigation is currently ongoing. The Teva product will cease to be available in the UK within the next few weeks as stocks are exhausted.
Only levothyroxine 100 microgram tablets supplied in the Teva and Numark brands are affected. Most people changing to or from these products will not experience any changes in their symptoms. However, there are some patient groups where control of thyroid function is particularly important. The MHRA advise the following patient groups should make an early appointment with their doctor:
- Pregnant women - especially if in the first 3 months of pregnancy (first trimester)
- Those with heart disease
- Those under treatment with TSH suppressive doses of levothyroxine following treatment for
thyroid cancer
Any patients feeling unwell whilst taking these tablets should report to their healthcare professionals as adjustment to their levothyroxine dose may be required.
Further information can be found in a ‘Questions and Answers’ document issued by the MHRA.
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03/02/2012
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Withdrawal of Butterbur-containing products
The MHRA
has issued a press release advising people to stop taking products containing butterbur (Petasites hybridus) as they could cause serious liver damage and organ failure. Unlicensed products containing butterbur are being marketed in the UK and the MHRA has asked the UK herbal industry to remove these products from sale. There are no butterbur-containing products licensed under the Traditional Herbal Registration scheme.
Butterbur is most commonly used to treat migraine and hayfever. It contains pyrrolizidine alkaloids which have been shown to cause liver damage and organ failure.
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20/01/2012
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Statins: risk of hyperglycaemia and diabetes
This month’s Drug Safety Update highlights an association between statin use and new onset diabetes (NOD). The risk appears to be mainly in people who are already at increased risk of developing diabetes. However, the overall benefits of statins strongly outweigh any risks, including in those at risk of developing diabetes or those with pre-existing diabetes. The MHRA advises that at-risk patients should be monitored both clinically and biochemically according to national guidelines.
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20/01/2012
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Atomoxetine (Strattera ): new contraindications, warnings, and advice for monitoring
Atomoxetine can cause clinically important increases in blood pressure, heart rate, or both, in a small proportion of patients. The MHRA has updated its safety advice for atomoxetine in this month’s Drug Safety Update. It should not be used in people with severe cardiovascular or cerebrovascular disorders. Thorough
pretreatment screening and regular monitoring of cardiovascular status is recommended. Specialist cardiac evaluation and advice should be sought if pretreatment findings suggest cardiac disease or history, or if symptoms suggesting cardiac disease are found during treatment.
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20/01/2012
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The Diabetes Drug Which May Aid Weight Loss?
NHS Choices Behind The Headlines have produced an assessment on claims in the media that Glucagon-like peptide-1 receptor (GLP-1R) agonists could be useful for managing obesity. The report looks in detail at the quality and outcomes of a systematic review published in the British Medical Journal, which concluded that GLP-1R agonists did appear to be associated with significant weight loss in patients with or without type 2 diabetes. However, further research is required in this area.
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17/01/2012
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NICE releases updated epilepsy guidance
NICE have released new guidelines (CG 137) for the treatment of epilepsy in children and adults in primary and secondary care. The new guidance contains updated information on the use of generic preparations for patients with epilepsy.
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17/01/2012
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NICE: Rivaroxaban preliminary guidance
The National Institute for Health and Clinical Excellence (NICE) have published draft recommendations for consultation on using rivaroxaban for the prevention of stroke and systemic embolism in people with atrial fibrillation. NICE are inviting comments from consultees, commentators, and the public on this guideline. The deadline for the consultation is 30th January 2012.
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13/12/2011
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High Strength Black Cohosh Capsules found on the market
The MHRA has released a warning over a brand of unlicensed black cohosh capsules. FSC Black Cohosh 1000mg contain 50 times the recommended amount of black cohosh for treatment of menopausal symptoms and are thought to be being sold online and in independent health shops. Patients are advised not to take the product and consult their doctor if they have any symptoms following consumption.
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24/10/2011
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Product Recall: all batches of Preflucel® vaccines
The MHRA has issued a Class1 Drug Alert recalling all batches of Preflucel® (influenza) vaccines. No further Preflucel® of any batch should be administered at this time.
This is taken as a precautionary measure, following a higher than expected frequency of reports of adverse reactions following administration of certain batches of Preflucel® (VNV5L010C and VNV5L010A).
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26/08/2011
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MHRA warned public to be extra vigilant when purchasing and using Nurofen Plus
The MHRA is advising people to be extra vigilant if taking Nurofen Plus® pain relief tablets following reports that the anti-psychotic drug, Seroquel
XL® 50mg, has been found within some Nurofen Plus® packets. Only three defective packs have been found in pharmacies across the UK. Seroquel® tablets have not been found within a blister strip labelled as Nurofen®. Further information can be found on the MHRA website (www.mhra.gov.uk).
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25/08/2011
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Happy Birthday to The MINT!
Our Newsletter publication, Medicines Information News Today (The Mint) recently celebrated its one year anniversary. The August 2011 edition is now available for download, and includes articles like:
- Dangers of online slimming pills
- Women, antidepressants, and stroke risk
- Starflower- Herbal Medicines Quick Take
- New and interesting updates from UKMi
The Mint is aimed at primary care health professionals in the Northern and Yorkshire region, and aims to help you keep up to date with important news events and documents in the field of medicines information.
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25/08/2011
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New Text Messaging Service available
The RDTC Regional Medicines Information Service is pleased to offer a new text messaging service to our
users.
We appreciate it can be difficult to contact our enquirers due to their busy schedules, particularly in primary care. In order to avoid undue delay or inconvenience, we can now send you a text to inform you when your answer is ready. You can then call us back at your own convenience to receive your answer.
If you wish
to use our new text messaging service, please provide a mobile telephone number to the member of staff who takes your enquiry.
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25/08/2011
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Blogs for Primary Care
The RDTC Medicines Information Service has collated a list of useful blogs for primary care healthcare professionals to help them keep up to date with medicines information news
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25/08/2011
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Pandemrix- Restricted use in people under 20 years of age
Following concerns about a suspected link between the Pandemrix® (influenza A [H1N1]) vaccine and narcolepsy in children and adolescents, a review undertaken by the European Medicines Agency concluded that the vaccine may only be used in people under 20 years of age if the recommended annual seasonal trivalent influenza vaccine is unavailable and if immunization against H1N1 is still needed.
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