Medicines alerts & safety issues

Drug Safety Update:

The January 2019 issue of Drug Safety update on

Tapentadol (Palexia): risk of seizures and reports of serotonin syndrome when co-administered with other medicines

Tapentadol may increase seizure risk in patients taking other medicines that lower seizure threshold, for example, antidepressants and antipsychotics. Serotonin syndrome has also been reported when tapentadol is used in combination with serotoninergic antidepressan

Ipilimumab (Yervoy): reports of cytomegalovirus (CMV) gastrointestinal infection or reactivation

Patients on ipilimumab who present with diarrhoea or other symptoms of colitis, and those who do not respond to steroid treatment for immune-related colitis, should be investigated to exclude other causes, including infections such as cytomegalovirus (CMV).

Yellow Card App: download the updated App to receive the latest MHRA safety news and report suspected side effects, including in pregnancy

The Yellow Card App has been updated to make it easier to use, to have useful new features, and to support reporting a suspected reaction related to medicine exposure during pregnancy. Download the App today and let us know your thoughts

Letters and drug alerts sent to healthcare professionals in December 2018

In December 2018, a letter was sent to notify healthcare professionals of the discontinuation of Zovirax (Aciclovir) eye ointment. We also highlight the recent recall of Actavis batches of irbesartan/hydrochlorothiazide tablets from pharmacies as a precautionary measure due to possible contamination with N nitrosodiethylamine (NDEA




West Yorkshire Fire & Rescue Service – Essential Information for Health Care Professionals

Following local deaths, West Yorkshire Fire & Rescue Service has produced a YouTube Video for healthcare professionals warning that emollients can increase the risk of a fire developing. Please watch it and discuss it within your team.

There is also a short two sided presentation and poster for patients/carers. Please encourage them to read and disseminate.

Watch Commander, Chris Bell, has also highlighted the risks on his Twitter account @WYFRSChrisBell and there is also information on the Fire Service’s website, including this letter from the Deputy Chief Fire Officer

West Yorkshire Fire & Rescue Service – Paraffin based creams health care professional letter


They would like you to consider:

  • All of these products are safe to use but they all increase the flammability of fabrics. The problem arises when an ignition source (primarily smoking materials such as matches and some lighters) is introduced and the bedding the person is lying on, the chair they are sitting on, the clothes or dressings they are wearing are accidentally set on fire.
  • Changing prescriptions to lower paraffin containing products will not reduce the fire risk.
  • Preliminary scientific research is also showing that non-paraffin alternatives will also not reduce the fire risk.
  • The potential fire risk therefore applies to all emollients.


They strongly recommend:

  1. In line with various Coroner’s reports to Prevent Future Deaths that all those who prescribe, dispense or apply these products should give a verbal warning about these fire risks to their patients, customers, clients or people they are caring for. This is in addition to the warnings that will appear on these products.
  2. If anyone has concerns that someone is displaying high risk behaviours around fire and the use of emollients, that a referral is made to us (or your local fire service)so that we can try to mitigate the risk through information, advice and appropriate interventions.


West Yorkshire Fire Service are visiting all community pharmacies across the county to help raise awareness about the potential fire safety issues with these products.


Medicines and Healthcare products Regulatory Agency (MHRA)

The MHRA has also highlighted the risks in a press release.

It was previously thought the risk occurred with emollients which contain more than 50% paraffins.  However, evidence now points to a risk with emollients which contain lower levels of paraffin and with paraffin-free emollients. This advice therefore applies to all emollients whether they contain paraffin or not.

It is important people prescribing, dispensing or using any emollient, or caring for someone who uses an emollient, are aware of the potential fire risks and take appropriate action.

Further details are available here Press Release MHRA 181218


BBC News Health

BBC News Health has again highlighted the dangers of using skin preparations whilst smoking or using naked flames.

For further information see this document which includes advice for both healthcare professionals and patients.


Medical devices: software applications (apps)

Information on when software applications (apps) considered to be a medical device and how they are regulated.  Updated guidance issued to help identify the health apps which are medical devices and make sure they comply with regulations and are acceptably safe.



Further Resources

Drug safety update: paraffin based skin emollients on dressings or clothing: fire risk (includes information on where to report incidents)

National Patient Safety Agency (now NHS Improvement)

Patient safety video

West Sussex Coroner’s Report: lower strength paraffin-based products

Risk assessment provided by Locala

Risk Assessment Template.pdf

BBC News Health


Resources to support safe use of valproate in women and girls

Valproate medicines must not be used in women of childbearing potential unless the Pregnancy Prevention Programme is in place. Actions for GPs, specialists and dispensers are available here. The link also includes how to order packs of information for patients/carers.

Further resources:

Valproate use by women and girls includes a video for healthcare professionals, patient cards/booklets, patient support networks etc.

Letter to pharmacists setting out urgent actions.

Patient Safety Alert – Resources to support safe use of valproate apr17.

Drug safety update – Advice for Healthcare Professionals:

Valproate and developmental disorders: patient review and further consideration of risk minimisation measurements .


Reporting ADRs directly to MHRA

Healthcare professionals can now report suspected adverse drug reactions directly to the Medicines and Healthcare products Regulatory Agency. Further details are available from here.


Interactions with HIV medicines

Some commonly prescribed medicines interact with certain medicines used for HIV infection. These include corticosteroid inhalers, nasal sprays and intra-articular injections. If a corticosteroid is necessary, beclometasone is a safer option as it is less dependent on CYP3A metabolism.

The MHRA has issued a Drug Safety Update about cobicistat, ritonavir and corticosteroids.

Interactions can be checked using this website.



A patient safety alert has been issued about the risk of severe harm and death resulting from withdrawing insulin from pen devices. This notes that

56 incidents have been reported which were associated with withdrawing insulin from insulin pens or refill cartridges:

• 12 described drawing up insulin directly from pens or cartridges

• 9 described a failure of safety needle

• 9 described incorrect technique with safety needles (healthcare professional)

• 6 described incorrect technique with safety needles (patients)

• 10 described other themes.

Extracting insulin from pen devices or cartridges is dangerous and should not happen.

A local newsletter about concern regarding high strength insulin and the dangers of taking insulin from pens or cartridges is available here:

UPDATED MARCH 2017 newsletter_concerns re high strengths insulins and withdrawing insulin


•The National Pharmacy Association have produced an Insulin Identification Checker to assist pharmacists and other relevant members of staff with selecting the correct insulin for dispensing against generic prescriptions.

• see key therapeutic topic from NICE on safer insulin prescribing. It includes actions to take to make insulin administration safer.


Other alerts and guidelines


Public Health England – Advice for prescribers on the risk of the misuse of pregabalin and gabapentin

Please see the link to guidance  published by Public Health England on the risk of misuse of pregabalin and gabapentin; this guidance explains when to avoid starting and how to reduce / stop use.


Medicines Safety Sub-group – Nefopam bulletin

Please see the link to the Medicines Safety Bulletin that focuses on Nefopam; this bulletin also provides information on prescribing recommendations and an example of a Nefopam withdrawal regime.


Clozapine Patient Safety Alert: Clozapine

A reminder of the potentially fatal risk of intestinal obstruction, faecal impaction, and paralytic ileus as a result of constipation and reduced gastric motility.


Benzodiazepines and risk of suicide

Patient Safety Alert: Benzodiazepines and risk of suicide

A bulletin has been produced to highlight the potential risks of suicide associated with benzodiazepine prescribing and withdrawal.



Fentanyl patches

Between July 2014 and October 2018, the MHRA received 5 reports of fatal incidents of accidental exposure, accidental overdose, or product adhesion issue with fentanyl patches. Information for patients and care givers is available from the MHRA.



Advice on diamorphine and intrasite gel

The CDAO is aware of the unlicensed use of Intrasite gel and diamorphine injection in certain settings.

The decision to use this would be a clinical judgement for the individual prescriber.

In all cases, if this is the chosen treatment, both the person administering the treatment, and the patient, must be  aware of its unlicensed status. There must also be a full audit trail for the use of the diamorphine (including destruction details of any part ampoules that may have been discarded)

Regarding treatment suitability and evidence please contact the Yorkshire Cancer Network.


Newsletters about CDs

• The South West of England has issued a newsletter about risks with morphine sulphate solution 10mg/5ml.

South West England CD Newsletter Aug 2016

• NHS England Yorkshire and The Humber has issued a newsletter about prescribing controlled drugs for temporary patients

NHS England – Yorkshire and The Humber CD Newsletter – December 2016