GOV.UK
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Daclizumab (Zinbryta▼) and risk of severe liver injury: initiation in multiple sclerosis now restricted, promptly review patients already on treatment
While an urgent EU-wide review of new information on liver safety is under way, promptly review patients on treatment.
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Bendamustine (Levact): increased mortality observed in recent clinical studies in off-label use; monitor for opportunistic infections, hepatitis B reactivation
Recent clinical trials have shown increased mortality when bendamustine (Levact) was used in combination treatments outside its approved indications.
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Nivolumab (Opdivo▼), pembrolizumab (Keytruda▼): reports of organ transplant rejection
There have been reports of rejection of solid organ transplants in patients treated with nivolumab or pembrolizumab.
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Letters sent to healthcare professionals in June 2017
Letters were sent about Arsenic Trioxide (Trisenox), Uptravi▼ (selexipag), DepoCyte (cytarabine), Cinryze▼ (C1 esterase inhibitor [human]), and Clexane (enoxaparin sodium).
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Medical Device Alerts issued in June 2017
Alerts were recently issued about high concentration oxygen masks, metal-on-metal (MoM) hip replacements, and BVM (Bag-Valve-Mask) manual resuscitation systems.
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Denosumab (Prolia, Xgeva▼): reports of osteonecrosis of the external auditory canal
Denosumab is associated with a risk of osteonecrosis of the jaw, osteonecrosis of the external auditory canal has also been reported with denosumab.
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Brimonidine gel (Mirvaso): risk of systemic cardiovascular effects; not to be applied to damaged skin
Systemic cardiovascular effects including bradycardia, hypotension, and dizziness have been reported after application.
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Pseudoephedrine and ephedrine: regular review of minimising risk of misuse in the UK
Sales restrictions introduced in 2008 continue to be successful in managing the risk of misuse of pseudoephedrine and ephedrine.
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e-cigarettes and refill containers (e-liquids): report suspected side effects and safety concerns
Use the Yellow Card Reporting Scheme to support the safety of e-cigarettes and refill containers (e-liquids).
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Letters sent to healthcare professionals in May 2017
Letters were sent about Pharmalgen (Bee Venom and Wasp Venom) Initial kits, bendamustine (Levact), and ERWINASE.
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Medical Device Alerts issued in May 2017
Alerts were issued about LIFEPAK 1000 automatic external defibrillators, Mitroflow LX (sizes 19mm and 21mm) biological replacement pericardial aortic heart valves, and Accu-Chek Insight insulin pumps.
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Finasteride: rare reports of depression and suicidal thoughts
We have received reports of depression and, in rare cases, suicidal thoughts in men taking finasteride 1 mg (Propecia) for male pattern hair loss.
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New CPD e-learning module on reporting suspected adverse drug reactions
You can use our free e-learning modules to find out more about how and when to report suspected adverse drug reactions and earn CPD credits at the same time.
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Letters sent to healthcare professionals in April 2017, including a reminder of the retigabine (Trobalt) withdrawal
A summary of letters sent to healthcare professionals, including an important reminder about the withdrawal of retigabine (Trobalt) from the market.
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Valproate and developmental disorders: new alert asking for patient review and further consideration of risk minimisation measures
Babies born to mothers who take valproate medicines (Epilim▼, Depakote▼) during pregnancy have a 30–40% risk of developmental disability and a 10% risk of birth defects.
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Ponatinib (Iclusig▼): risk of vascular occlusive events—updated advice on possible dose reduction
Prescribers should consider reducing the dose of ponatinib to 15 mg a day for patients with chronic phase chronic myeloid leukaemia (CP-CML) who have achieved a major cytogenetic response.
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Multiple sclerosis therapies: signal of rebound effect after stopping or switching therapy
Healthcare professionals should report any suspected adverse effects relating to fingolimod (Gilenya▼) or other treatments for multiple sclerosis, including suspected adverse effects occurring after discontinuation, via the Yellow Card Scheme.
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Letters sent to healthcare professionals in March 2017
A summary of letters sent to relevant healthcare professionals.
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SGLT2 inhibitors: updated advice on increased risk of lower-limb amputation (mainly toes)
Canagliflozin may increase the risk of lower-limb amputation (mainly toes) in patients with type 2 diabetes.
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Launch of pilot reporting scheme for harms associated with illicit drugs, particularly new psychoactive substances
We are launching a pilot scheme for healthcare professionals in the UK to report suspected adverse reactions to illicit drugs, particularly new psychoactive substances.
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Hyoscine butylbromide (Buscopan) injection: risk of serious adverse effects in patients with underlying cardiac disease
Prescribing information has been updated to help to minimise the risk of serious adverse reactions in patients with cardiac disease.
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Yellow Card reporting added to second clinical software system
Healthcare professionals who use Vision can now report suspected adverse reactions to MHRA directly through their clinical software.
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Letters sent to healthcare professionals in January 2017
A summary of letters sent to relevant healthcare professionals in January 2017.
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Direct-acting antiviral interferon-free regimens to treat chronic hepatitis C: risk of hepatitis B reactivation
All patients should be screened for hepatitis B before starting treatment for chronic hepatitis C with direct-acting antiviral interferon-free regimens.
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Direct-acting antivirals to treat chronic hepatitis C: risk of interaction with vitamin K antagonists and changes in INR
INR should be monitored closely during treatment of chronic hepatitis C with direct-acting antivirals in patients also receiving vitamin K antagonists (eg, warfarin), because of possible changes in liver function during treatment.
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Apremilast (Otezla ▼): risk of suicidal thoughts and behaviour
There is an increased risk that some patients may experience psychiatric symptoms with apremilast, including depression and suicidal thoughts.
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Intravenous N-acetylcysteine (NAC) for paracetamol overdose: reminder of authorised dose regimen; possible need for continued treatment with NAC
The authorised dose regimen for N-acetylcysteine (NAC) in paracetamol overdose is 3 consecutive bags given intravenously over 21 hours.
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Letters sent to healthcare professionals in December 2016
A summary of letters sent to relevant healthcare professionals in December 2016.
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Cobicistat, ritonavir and coadministration with a steroid: risk of systemic corticosteroid adverse effects
Coadministration of a corticosteroid with an HIV-treatment-boosting agent may increase the risk of adrenal suppression due to a pharmacokinetic interaction.
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Letters sent to healthcare professionals in November 2016
A summary of recent letters sent to relevant healthcare professionals, to inform them of updated safety information.
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Spironolactone and renin-angiotensin system drugs in heart failure: risk of potentially fatal hyperkalaemia—clarification, December 2016
In light of feedback, we have clarified our article on concomitant use of these medicines in heart failure.
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Brimonidine gel (Mirvaso): risk of exacerbation of rosacea
Some patients may have exacerbation or rebound symptoms of rosacea.
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Show your support for reporting suspected adverse drug reactions
We are running a social media campaign to promote the reporting of suspected adverse drug reactions to the Yellow Card Scheme in support of an awareness week from 7 to 11 November 2016.
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Letters sent to healthcare professionals in October 2016
A summary of recent safety letters sent to relevant healthcare professionals
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Etoricoxib (Arcoxia): revised dose recommendation for rheumatoid arthritis and ankylosing spondylitis
Prescribing information has been updated to introduce a lower recommended dose of 60 mg daily for patients with rheumatoid arthritis or ankylosing spondylitis.
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Letters sent to healthcare professionals in September 2016, including retigabine withdrawal
A summary of letters sent to healthcare professionals in September 2016, including important information for professionals who specialise in epilepsy treatment regarding the withdrawal from the market of retigabine (Trobalt).
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Levonorgestrel-containing emergency hormonal contraception: advice on interactions with hepatic enzyme inducers and contraceptive efficacy
Medicines or herbal remedies that induce CYP3A4 enzymes reduce blood levels of levonorgestrel, which may reduce emergency contraceptive efficacy.
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Posaconazole (Noxafil): tablets and oral suspension are not directly interchangeable
Switching from posaconazole oral solution to tablets has resulted in cases of dose-related toxicity, whereas switching from tablets to oral solution has resulted in underdosing and lack of efficacy.
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Idelalisib (Zydelig▼): updated indications and advice on minimising the risk of infection
Updated advice for healthcare professionals is available, after conclusion of a review of the safety of idelalisib, including the risk of infection.
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Letters sent to healthcare professionals in August 2016
A summary of safety letters sent to healthcare professionals in August 2016
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Riociguat (Adempas): not for use in patients with pulmonary hypertension associated with idiopathic interstitial pneumonias
Patients with pulmonary hypertension associated with idiopathic interstitial pneumonias should not be treated with riociguat in light of interim results from a recently terminated study.
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Letters sent to healthcare professionals in July 2016
A summary of letters sent to healthcare professionals in July 2016 to inform of safety information for riociguat and for posaconazole.
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Warfarin: reports of calciphylaxis
Calciphylaxis is a very rare but serious condition causing vascular calcification and skin necrosis.
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Citalopram: suspected drug interaction with cocaine; prescribers should consider enquiring about illicit drug use
Possible illicit drug use should be considered when prescribing medicines that have the potential to interact adversely.
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N-acetylcysteine: risk of false-low biochemistry test results due to interference with Siemens assays
N-acetylcysteine may interfere with assays from Siemens ADVIA Chemistry and Dimension/Dimension Vista instruments, leading to false-low biochemistry test results.
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Letters sent to healthcare professionals in June 2016
In June 2016, a letter was sent to healthcare professionals about Thalidomide Celgene.
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Canagliflozin (Invokana▼, Vokanamet▼): signal of increased risk of lower extremity amputations observed in trial in high cardiovascular risk patients
A signal of increased lower limb amputation (primarily of the toe) in people taking canagliflozin compared with placebo in a clinical trial in high cardiovascular risk patients is currently under investigation.
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Nexplanon (etonogestrel) contraceptive implants: reports of device in vasculature and lung
There have been rare reports of Nexplanon implants having reached the lung via the pulmonary artery.
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Topical miconazole, including oral gel: reminder of potential for serious interactions with warfarin
In view of reports of serious bleeding events in patients taking miconazole and warfarin, we are considering further measures to minimise the risk of potentially serious interactions between miconazole and warfarin.
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Letters sent to healthcare professionals in May 2016
In May 2016, letters were sent regarding Nexplanon (etonogestrel implant) and ERWINASE.
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