MHRA Safety Roundup: September 2025
Source: gov.uk (2025-09-30)

Summary of the latest safety advice for medicines and medical device users

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MHRA Safety Roundup: September 2025 (https://assets.publishing.service.gov.uk/media/68dbbb12750fcf90fa6ffc1c/MHRA_Safety_Roundup_-_September_2025.pdf)

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Paracetamol and pregnancy - reminder that taking paracetamol during pregnancy remains safe

Drug Safety Update

Access the full article (https://www.gov.uk/drug-safety-update/paracetamol-and-pregnancy-reminder-that-taking-paracetamol-during-pregnancy-remains-safe)

Summary

Patients should be reminded and reassured that there is no evidence that taking paracetamol during pregnancy causes autism in children. Paracetamol is recommended as the first-choice pain reliever for pregnant women, used at the lowest dose and for the shortest duration. It also acts as an antipyretic and is therefore used to treat fever. Patients should not stop taking their pain medicines as untreated pain and fever can pose risks to the unborn child.

Key Advice for Healthcare Professionals
- there is no evidence that taking paracetamol during pregnancy causes autism in children
- pregnant women should be advised to continue to follow existing NHS guidance (https://www.nhs.uk/medicines/paracetamol-for-adults/pregnancy-breastfeeding-and-fertility-while-taking-paracetamol-for-adults/) and speak to their healthcare professional if they have questions about any medication during pregnancy
- untreated pain and fever can pose risks to the unborn baby, so it is important that patients continue to manage these symptoms with the recommended treatment. If pain or fever does not resolve, patients are advised to seek advice from their healthcare professional
- patients should not swap to alternatives such as ibuprofen. Non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, are generally not recommended during pregnancy
- the MHRA regularly reviews the safety of paracetamol including during pregnancy to ensure that the benefits to the patient and unborn baby outweigh any risks
- recent existing studies do not show a causal association between paracetamol use during pregnancy and autism. There are many potential contributing factors in the development of autism, including but not limited to concomitant diseases and family inheritance
- members of the public and healthcare professionals are encouraged to report any suspected side effects from medicines, including paracetamol, to the MHRA’s Yellow Card scheme (https://yellowcard.mhra.gov.uk/)
Key Advice for Healthcare Professionals to Provide to Patients
- paracetamol is recommended as the first-choice pain reliever for pregnant women, used at the lowest dose and for the shortest duration. It can also be used to treat fever
- pregnant women should be advised to continue to follow existing NHS guidance (https://www.nhs.uk/medicines/paracetamol-for-adults/pregnancy-breastfeeding-and-fertility-while-taking-paracetamol-for-adults/) and speak to their healthcare professional if they have questions about any medication during pregnancy
- untreated pain and fever can pose risks to the unborn baby, so it is important that patients continue to manage these symptoms with the recommended treatment. If pain or fever does not resolve, patients are advised to seek advice from their healthcare professional
- patients should not swap to alternatives such as ibuprofen, as non-steroidal anti-inflammatory drugs (NSAIDs) are generally not recommended during pregnancy
Profemur Cobalt Chrome Modular Neck Hip Replacements: Higher than anticipated risk of revision surgery, metal-wear effects and component fracture (DSI/2025/005)

Device Safety Information

Access the full article (https://www.gov.uk/drug-device-alerts/profemur-cobalt-chrome-modular-neck-hip-replacements-higher-than-anticipated-risk-of-revision-surgery-metal-wear-effects-and-component-fracture-dsi-slash-2025-slash-005)

Summary

An MHRA investigation has found increased risks of wear and corrosion, including an increased occurrence of device fracture and revision surgery associated with cobalt chrome-containing Profemur modular neck hip stem components. Patients implanted with affected Profemur devices are to be invited for a clinical review to inform them of the identified risks, assess their clinical presentation and discuss the need for continued follow-up.

Key Advice for Healthcare Professionals

Clinical Follow-up Recommendation:
- trusts / hospitals should review local and national databases (e.g. the National Joint Registry) to identify patients implanted with the specified devices
- all identified patients should be contacted and invited to attend a virtual or face-to-face clinical review under the prioritised conditions recommended in Table 1
Table 1. Recommended risk prioritisation groupings for patients implanted with affected devices.

*Patient risk grouping is defined as follows:

Highest Risk Group: Patients implanted with the recalled CoCr modular neck product code PHAC1254

Moderate Risk Group: Patients implanted with a CoCr neck on either a Profemur or Ancafit titanium alloy or Profemur Xm CoCr stem. This group includes patients whose implant material combinations are unknown

Lower Risk Group: Patients implanted with a titanium alloy neck on a Profemur Xm CoCr stem
- all identified patients, regardless of risk grouping, should be informed of the risks provided within this Device Safety Information communication
- In England, Northern Ireland, or Wales: laboratories participating in the UK National External Quality Assessment Service (UK NEQAS).
- In Scotland: the Scottish Trace Element and Micronutrient Reference Laboratories
- conduct cross-sectional imaging using MARS MRI or ultrasound, depending on local trust or hospital policy
- each patient should be assessed on an individual basis
- abnormal imaging findings
- blood metal levels that are higher than expected and/or rising
- deterioration in hip-related clinical function or Patient Reported Outcome Measures (PROMs)
- symptomatic patients should be followed up annually while the device remains in place
- asymptomatic patients should be advised to return if they develop new or concerning symptoms
*There is no agreed threshold value for whole blood metal levels that either predicts outcome, or mandates revision. Decisions to revise are influenced by patient factors, blood metal levels, imaging findings, and implant type and position. Other patient specific factors may need to be considered when interpreting results for blood metal levels.

Key Advice for Healthcare Professionals to Provide to Patients
- the majority of patients implanted with these hip replacements have well-functioning hips and are thought to be at a low risk of developing serious problems
- a small number of patients implanted with these hips may, however, develop soft tissue reactions or other metal-related effects resulting in the need for revision surgery
- patients with affected devices should expect to be contacted and, if in the highest or moderate patient risk groups, be invited for a clinical assessment to consider and discuss whether any action is required. Patients in the lowest risk group will be invited only if they are concerned or are symptomatic
- patients who have an affected hip replacement device implanted, should expect to be contacted by their surgeon or implanting hospital. There is no need for patients to contact their surgeon or implanting hospital directly
- in the meantime, if patients experience any new or unexpected symptoms including pain, stiffness, or instability, they should speak to their implanting surgeon or the hospital where their surgery was performed in the first instance
Letters, medicines recalls and device notifications sent to healthcare professionals in September 2025

Direct Healthcare Professional Communications

We received notification that the following Direct Healthcare Professional Communications were sent or provided to relevant healthcare professionals in September 2025:
- Rybelsus® (oral semaglutide): risk of medication error due to introduction of new formulation with increased bioavailability (https://assets.publishing.service.gov.uk/media/68dbb351dadf7616351e4c1d/DHPC_Letter-_Rybelsus_2G.pdf). Sent to relevant stakeholders in August 2025
- Adjuvanted Zoonotic Influenza Vaccine (Surface Antigen, Inactivated) - Seqirus suspension for injection in pre-filled syringe. Zoonotic influenza vaccine (H5N8) (surface antigen, inactivated, adjuvanted) (https://assets.publishing.service.gov.uk/media/68dbb377750fcf90fa6ffc09/Adjuvanted_Zoonotic_Influenza_Vaccine_DHPC_Letter.pdf). Sent to relevant stakeholders in June 2025
- Sildenafil 50mg orodispersible film – new dosage form (https://assets.publishing.service.gov.uk/media/68dbb39f8c1db6022d0c9f0c/Boots-_Direct_Healthcare_Professional_Communication-_Sildenafil_50mg_orodispersible_film__New_dosage_form__MM_Signed__002_.pdf)
- Ontozry (cenobamate) - over labelling of expiry date on blister pack (https://assets.publishing.service.gov.uk/media/68dbb3b98c1db6022d0c9f0d/BeachCourse_DHCP_letter_-_Ontozry_xx-xxxx-xxxx_JI.pdf)
- Lipidem® emulsion for infusion (10 x 500 ml, 6 x 1000 ml, glass bottles; PL xx-xxxx-xxxx)– Important information on subvisual agglomerates, use of an infusion filter for fat emulsions (https://assets.publishing.service.gov.uk/media/68dbb3e2750fcf90fa6ffc0c/Lipidem__Customer_letter.pdf)
Medicine Recalls and Notifications

In September 2025, recalls and notifications for medicines were issued on:

Class 4 Medicines Defect Notification: (https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-notification-hikma-farmaceutica-gemcitabine-2g-slash-52-dot-6ml-concentrate-for-solution-for-infusion-el-25-a-slash-43) Hikma Farmacêutica, Gemcitabine 2g/52.6ml concentrate for solution for infusion, EL(25)A/43. Issued 4 September 2025.

Hikma Farmacêutica (Portugal) S.A has informed the MHRA that the Patient Information Leaflet (PIL) contained within batch CB0033 of Gemcitabine 2g/52.6ml concentrate for solution for infusion does not contain the side effects of serious skin reactions.

Medical Device Field Safety Notices

Find recently published Field Safety Notices (https://www.gov.uk/drug-device-alerts?alert_type%5B%5D=field-safety-notices)

Report suspected drug reactions and device incidents on a Yellow Card

Please continue to report suspected adverse drug reactions and device incidents. Your report will help us safeguard public health.

When reporting, please provide as much information as possible, including information about medical history, any concomitant medication, onset timing, treatment dates and particularly if a side effect continued or started after treatment was stopped.

Report a medicine

Healthcare professionals should report via a Yellow Card to:

the Yellow Card website (https://yellowcard.mhra.gov.uk/)

the Yellow Card app; download from the Apple App Store (https://itunes.apple.com/us/app/apple-store/id990237487?pt=117756671&ct=EYC&mt=8) or Google Play Store (https://play.google.com/store/apps/details?id=uk.org.mhra.yellowcard&referrer=utm_source%3DEYC%26utm_medium%3Dcpc%26anid%3Dadmob)

some clinical IT systems for healthcare professionals (EMIS, SystmOne, Vision, MiDatabank, and Ulysses)

Reporting for medical devices

Healthcare professionals should report incidents:
- in England and Wales to the Yellow Card website (https://yellowcard.mhra.gov.uk/) or via the Yellow Card app
- in Scotland to Incident Reporting & Investigation Centre (IRIC) (https://www.nss.nhs.scot/health-facilities/incidents-and-alerts/report-an-incident/) and their local incident recording system
- in Northern Ireland to the Yellow Card website in accordance with your organisations medical device policies and procedures
Reporting for patients

Patients should report via a Yellow Card to:
- the Yellow Card website (https://yellowcard.mhra.gov.uk/)
- the Yellow Card app; download from the Apple App Store (https://itunes.apple.com/us/app/apple-store/id990237487?pt=117756671&ct=EYC&mt=8) or Google Play Store (https://play.google.com/store/apps/details?id=uk.org.mhra.yellowcard&referrer=utm_source%3DEYC%26utm_medium%3Dcpc%26anid%3Dadmob)
News Roundup

Nitrofurantoin: reminder of the risks of pulmonary and hepatic adverse drug reactions

We would like to remind health care professionals prescribing nitrofurantoin that they should be vigilant for new or worsening respiratory symptoms such as a persistent cough or respiratory infections while taking nitrofurantoin, especially in the elderly. Patients receiving long-term therapy, for example for recurrent urinary tract infections, should be closely monitored.

Pulmonary side effects such as pneumonitis can occur after short- or long-term treatment and nitrofurantoin should be discontinued if new or worsening symptoms occur. Please see our previous communication for more information: Nitrofurantoin: reminder of the risks of pulmonary and hepatic adverse drug reactions - GOV.UK (https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.gov.uk%2Fdrug-safety-update%2Fnitrofurantoin-reminder-of-the-risks-of-pulmonary-and-hepatic-adverse-drug-reactions&data=05%7C02%7CRisk.Comms%40mhra.gov.uk%7C8e6106de02ce494b353308ddf442b192%7Ce527ea5c62584cd2a27f8bd237ec4c26%7C0%7C0%7C638935289467724581%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=BDeYW3suKQUlEnfaQ6h1C5bzF7Bn4XzeovlyGi2qBHM%3D&reserved=0).

Trodelvy: Update to SmPC and Reminder of risk of serious side effects

Healthcare professionals are reminded that Trodelvy (Sacituzumab govitecan), which is indicated for some types of breast cancer, can cause severe or life-threatening neutropenia and that fatal infections have been observed. Neutropenia and febrile neutropenia are some of the most common serious side effects of Trodelvy.

An update has been made to the Summary of Product Characteristics (SmPC) for Trodelvy to recommend consideration of primary prophylaxis with granulocyte colony stimulating factor (G-CSF) in patients at increased risk of febrile neutropenia. A Direct Healthcare Professional Communication (DHPC (https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fassets.publishing.service.gov.uk%2Fmedia%2F688a3633048fff613a4d5bf8%2FFinal_DHPC_Trodelvy_GCSF_Prophylaxis.pdf&data=05%7C02%7CJudith.Heron%40mhra.gov.uk%7C454557e129484fcf527808ddf5ff3648%7Ce527ea5c62584cd2a27f8bd237ec4c26%7C0%7C0%7C638937198711580128%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=N6EbzK6oN%2BsmzWNpo%2Bd%2F4Vw1iFrjbgZmBluCtVq%2FvbU%3D&reserved=0)) was also published in July 2025.

Trodelvy increases the risk of neutropenia and infections and patients should be reminded to seek urgent medical attention at the first signs of fever or infection. They should be provided with a copy of the Patient Information Leaflet (PIL) (https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.medicines.org.uk%2Femc%2Fproduct%2F12880%2Fpil&data=05%7C02%7CJudith.Heron%40mhra.gov.uk%7C5202fcb30ac341acbfe108ddf69e77e6%7Ce527ea5c62584cd2a27f8bd237ec4c26%7C0%7C0%7C638937882712920871%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=AemSBHtqyYAO3cFZ8lWc0VBQ1IADqEh5u6B2MyfV1e8%3D&reserved=0). For full details of the indications and more information please refer to the SmPC (https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.medicines.org.uk%2Femc%2Fproduct%2F12880%2Fsmpc&data=05%7C02%7CJudith.Heron%40mhra.gov.uk%7C5202fcb30ac341acbfe108ddf69e77e6%7Ce527ea5c62584cd2a27f8bd237ec4c26%7C0%7C0%7C638937882712942926%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=HU2fz4sxvtrgUJLfp9nF%2F1BXVcyrTjN48kjWK5aZV1Q%3D&reserved=0) for Trodelvy.

Valproate prescribing report published

The MHRA has published the first in a series of reports (https://www.gov.uk/guidance/valproate-reproductive-risks#monitoring-impact) on trends in valproate prescribing as derived from the Clinical Practice Research Datalink (CPRD), in females and males in England.

This first report includes data from January 2018 to June 2024, and shows significant reductions in new and overall prescribing in both females and males aged xx-xxxx-xxxx, with notable shifts away from valproate as a first-line treatment. Going forward we plan to publish regular prescribing reports every 6 months.

Healthcare professionals must continue to follow measures in place (https://www.gov.uk/guidance/valproate-reproductive-risks#information-for-healthcare-professionals) for prescribing and dispensing of valproate.

MHRA reassures the public that taking paracetamol during pregnancy remains safe

The MHRA released a news story (https://www.gov.uk/government/news/mhra-confirms-taking-paracetamol-during-pregnancy-remains-safe-and-there-is-no-evidence-it-causes-autism-in-children) on 22 September, to reassure the public that paracetamol remains safe for use during pregnancy.

Additionally, on the day of the US announcement, we issued social media posts, (see our post on LinkedIn (https://www.linkedin.com/feed/update/urn:li:activity:7376271177750622210)) across our platforms, with a video of our Chief Safety Officer, Alison Cave, providing further reassurance. Please do share our posts to help further communicate this important message.

Please also see The Department of Health and Social Care blog post with Q&A (https://healthmedia.blog.gov.uk/2025/09/23/paracetamol-and-pregnancy-what-you-need-to-know/) and NHS England updated information page (https://www.nhs.uk/medicines/paracetamol-for-adults/pregnancy-breastfeeding-and-fertility-while-taking-paracetamol-for-adults/).

MHRA investigating unlicensed Botox products linked to hospital admissions

The MHRA’s Criminal Enforcement Unit has launched a number of criminal investigations following a spike in hospital admissions believed to be linked to the use of unlicensed botulinum toxin (Botox) products.

Botulism caused by botulinum toxin in cosmetic procedures is rare, but can be life-threatening. Symptoms can take up to four weeks to develop and may include difficulty swallowing, slurred speech and breathing difficulty. In severe cases, patients may require mechanical ventilation and intensive care treatment.

Please see our press release (https://www.gov.uk/government/news/mhra-crackdown-on-illegal-botox-after-victims-left-seriously-ill) for further information.

New Commission launched to accelerate NHS use of AI

The new National Commission on the Regulation of AI in Healthcare has officially launched. By bringing together clinical leaders, patient advocates and leading tech firms, the independent Commission will advise on a new regulatory framework aimed at accelerating safe access to AI in healthcare and across the NHS.

The Commission will review tech that’s being held back by regulatory uncertainty, like AI note-taking assistants for doctors. It will also provide regulatory clarity on various AI tools such as those used for radiology and pathology, and remote monitoring systems to support virtual care of patients from their own homes.

The MHRA will act on the recommendations of the Commission to support integration of AI technologies to make the NHS the most AI-enabled healthcare system in the world.

For more information, see the full announcement (https://www.gov.uk/government/news/new-commission-to-help-accelerate-nhs-use-of-ai).

MHRA and partners unite to reaffirm prescription weight-loss medicine advertising rules

The MHRA, in partnership with the Advertising Standards Authority (ASA) and General Pharmaceutical Council (GPhC), has released an updated Enforcement Notice reiterating the rules regarding advertising prescription-only medicines (POMs) for weight management.

Directed at businesses, primarily pharmacies, that make these medicines available to the public, the updated notice provides clarity on the kinds of claims and images in advertisements that could breach the rules.

Guidance on the advertising and promotion of prescription medicines in the UK can be found in the MHRA Blue Guide (https://www.gov.uk/government/publications/blue-guide-advertising-and-promoting-medicines).

Please see the MHRA news story (https://www.gov.uk/government/news/mhra-and-partners-unite-to-reaffirm-prescription-weight-loss-medicine-advertising-rules) for more information.

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