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There have been reports of worsening nasal congestion (rebound congestion) when the effects of nasal decongestant sprays or drops containing xylometazoline hydrochloride and oxymetazoline hydrochloride, wear off.
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Be especially alert for adverse drug reactions (ADRs) in patients taking more than one medicine and report any suspected ADRs to the Yellow Card Scheme. Show your support for the MHRA’s ADR awareness week campaign on 17–23 F…
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We ask healthcare professionals to be vigilant to adverse incidents involving software, apps, and artificial intelligence (AI) as medical devices and to report incidents to us via the Yellow Card scheme.
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Test liver function before and during treatment and tell patients to avoid sunlight exposure.
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Use of pioglitazone is associated with a small increased risk of bladder cancer. Healthcare professionals should be aware of new warnings and precautions for use in at-risk patients
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We have published guidance about the use of remote consultations for pregnancy prevention in women of childbearing potential and monitoring for signs of psychiatric reactions (especially depression) and other safety risks in…
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Recent information relating to COVID-19 vaccines and medicines that has been published since the October 2022 issue of Drug Safety Update, up to 24 November 2022.
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Clinical trials have reported an increased risk of renal dysfunction and mortality in critically ill or septic patients who received hydroxyethyl starch (HES) compared with crystalloids.
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Letters were sent about ranibizumab and Emerade adrenaline auto-injectors. Alerts were issued about ranitidine, paracetamol, omeprazole, mitomycin-C Kyowa, folic acid, and Emerade adrenaline auto-injectors.
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Liver function should be tested before and during treatment with temozolomide.
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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Stavudine should only be used when there are no appropriate alternatives, and for the shortest possible time.
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Updated prescribing advice provided.
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After every use, an ambulance should be called even if symptoms are improving, the individual should lie down with legs raised and, if at all possible, should not be left alone.
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Photosensitivity reactions are known side effects of methotrexate treatment and can be severe. Patients should be advised to take precautions to protect their skin in the sun.
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Fatal cases of tumour lysis syndrome (TLS) have been reported, some occurring in patients with chronic lymphocytic leukaemia receiving the lowest venetoclax dose used in the dose-titration schedule. For all patients, it is i…
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Drug interactions involving CYP2D6, genetic variants, and variability in clinical response
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Safety studies of Spiriva Respimat▼
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Recent information relating to COVID-19 vaccines and medicines that has been published since the October 2021 issue of Drug Safety Update, up to 12 November 2021.
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There is an increased risk of myopathy associated with high-dose (80 mg) simvastatin. The 80-mg dose should be considered only in patients with severe hypercholesterolaemia and high risk of cardiovascular complications who h…
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Extension of the indication for nicotine replacement therapy (NRT) to include harm reduction.
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Monitor thyroid-stimulating hormone (TSH) in patients treated with levothyroxine for at least the first month after starting and ending ritonavir treatment.
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A summary of letters and recent medicine recalls and notifications sent to healthcare professionals.
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The most important risk factors for uterine perforation are insertion during lactation and insertion in the 36 weeks after giving birth. Before inserting an IUS or IUD, inform women of the risk and the symptoms of perforatio…
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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 comb…
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Latest evidence suggests long-term use of combined oral contraceptives or progestogen-only injectable contraceptives is associated with a small increased risk of cervical cancer.
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A UK and Europe-wide review of available efficacy and safety data confirmed that reboxetine has benefit over placebo in its authorised indication.
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Epimax Ointment and Epimax Paraffin-Free Ointment can harm the eyes if used on the face. Do not prescribe these ointments for use on the face. Tell patients to wash their hands and avoid touching their eyes after using these…
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There have been reports of thrombotic microangiopathy and nephrotic syndrome linked to interferon beta treatment.
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A summary of recent letters and notifications sent to healthcare professionals about medicines.
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A summary of recent letters and notifications sent to healthcare professionals about medicines.
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Updated safety recommendations have been issued as part of the European review evaluating cases of neural tube defects in babies born to mothers who became pregnant while taking the HIV medicine dolutegravir. Evidence collec…
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To be used only in patients with acute blood loss and when crystalloids alone are not sufficient.
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There have been reports of necrotising and haemorrhagic pancreatitis in people taking exenatide some of which were fatal - stop exenatide treatment if pancreatitis is diagnosed.
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Use baricitinib with caution in patients with diverticular disease and in those concomitantly treated with medications associated with an increased risk of diverticulitis.
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We ask healthcare professionals to support new guidance for users of diabetes management equipment, their families, care givers and representatives.
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The MHRA has reviewed the warnings regarding addiction, dependence, withdrawal, and
tolerance for gabapentin, pregabalin, benzodiazepines, and z-drugs. The findings (detailed in the Public Assessment Report) were that it wa…
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A large study has shown no safety issues of concern relating to the use of metformin during pregnancy. The licence for metformin now reflects that it can be considered for use during pregnancy and the periconceptional phase …
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Warnings about the risk of severe and fatal burns are being extended to all paraffin-based emollients regardless of paraffin concentration. Data suggest there is also a risk for paraffin-free emollients. Advise patients who …
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In the UK, low-dose aspirin is licensed for prevention of thrombotic cerebrovascular or cardiovascular disease only in those who already have vascular disease—ie, secondary prevention.
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Discontinue baricitinib treatment permanently if clinical features of deep vein thrombosis or pulmonary embolism occur. Prescribers are reminded to use caution if using baricitinib in patients with risk factors for deep vein…
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Marketing authorisations for carisoprodol are to be suspended after a European review concluded that the risks of treatment outweigh the benefits.
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The growing number of oral tacrolimus products available on the market increases the potential for inadvertent switching between products, which has been associated with reports of toxicity and graft rejection. Therefore, to…
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Healthcare professionals should consider the possibility of second primary malignancy in patients treated with lenalidomide.
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Saquinavir at a reduced dose for the first week of treatment
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When children receiving replacement therapy for adrenal insufficiency are being switched from hydrocortisone tablets to Alkindi granules, parents or carers should be informed of the need to be extra vigilant for symptoms of …
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Letters were issued about parenteral nutrition products, ranibizumab, ingenol mebutate gel, adrenaline auto-injectors, and fingolimod. Recall alerts were recently issued about ranitidine, aripiprazole, and bisacodyl.
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Recent information relating to COVID-19 vaccines and medicines that has been published since the August 2022 issue of Drug Safety Update, up to 23 September 2022.
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Studies of cardiovascular risk don’t support prescribing changes.
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Routine monitoring of liver function now recommended.