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Recent MHRA Drug Safety Updates

In this section, we have the recent updates that apply to drugs in the Trust Formulary. Links can also be found against the product information in the A to Z and formulary sections.

Alerts are presented with the most recent first.

RSS Feed:
www.mhra.gov.uk/Stayconnected/RSSFeeds/DrugSafetyUpdate/index.htm

ProductFull UpdateAlert Description

July 2016
Warfarin: reports of calciphylaxis Link Calciphylaxis is a very rare but serious condition causing vascular calcification and skin necrosis.
Citalopram: suspected drug interaction with cocaine; prescribers should consider enquiring about illicit drug use Link Possible illicit drug use should be considered when prescribing medicines that have the potential to interact adversely.
N-acetylcysteine: risk of false-low biochemistry test results due to interference with Siemens assays Link N-acetylcysteine may interfere with assays from Siemens ADVIA Chemistry and Dimension/Dimension Vista instruments, leading to false-low biochemistry test results.
Letters sent to healthcare professionals in June 2016 Link In June 2016, a letter was sent to healthcare professionals about Thalidomide Celgene.

June 2016
Canagliflozin (Invokana▼, Vokanamet▼): signal of increased risk of lower extremity amputations observed in trial in high cardiovascular risk patients Link 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.
Nexplanon (etonogestrel) contraceptive implants: reports of device in vasculature and lung Link There have been rare reports of Nexplanon implants having reached the lung via the pulmonary artery.
Topical miconazole, including oral gel: reminder of potential for serious interactions with warfarin Link 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.
Letters sent to healthcare professionals in May 2016 Link In May 2016, letters were sent regarding Nexplanon (etonogestrel implant) and ERWINASE.

May 2016
BCR-ABL tyrosine kinase inhibitors: risk of hepatitis B reactivation Link Patients should be tested for hepatitis B virus before starting treatment with BCR-ABL tyrosine kinase inhibitors.
Pomalidomide (Imnovid▼): risk of hepatitis B reactivation Link Before starting treatment with pomalidomide, establish hepatitis B virus status in all patients.
Idelalisib (Zydelig▼): interim measures following signal of serious infection and deaths related to infection found in clinical trials Link There are new interim treatment recommendations for idelalisib for chronic lymphocytic leukaemia and follicular lymphoma in light of new findings from clinical trials outside its currently authorised drug combinations or indicated populations.
Letters sent to healthcare professionals in April 2016 Link In April 2016, letters were sent regarding canagliflozin (Invokana▼, Vokanamet▼), BCR-ABL tyrosine kinase inhibitors, pomalidomide (Imnovid▼), and retigabine (Trobalt)

April 2016
SGLT2 inhibitors: updated advice on the risk of diabetic ketoacidosis Link Test for raised ketones in patients with ketoacidosis symptoms, even if plasma glucose levels are near-normal.
Natalizumab (Tysabri▼): progressive multifocal leukoencephalopathy-updated advice to support early detection Link Perform a quantitative serum anti-JCV antibody test-including index value-to support risk stratification for progressive multifocal leukoencephalopathy.
Dimethyl fumarate (Tecfidera): updated advice on risk of progressive multifocal leukoencephalopathy Link Cases of progressive multifocal leukoencephalopathy have been reported in patients taking dimethyl fumarate for multiple sclerosis, who all had prolonged lymphopenia.
Fingolimod (Gilenya▼): risks of progressive multifocal leukoencephalopathy, basal-cell carcinoma, and opportunistic infections Link The immunomodulatory effects of fingolimod increase the risk of progressive multifocal leukoencephalopathy and opportunistic infections.
Apomorphine with domperidone: minimising risk of cardiac side effects Link Patients receiving apomorphine and domperidone require an assessment of cardiac risk factors and ECG monitoring to reduce the risk of serious arrhythmia related to QT-prolongation.
Aflibercept (Zaltrap▼): minimising the risk of osteonecrosis of the jaw Link Dental examination and appropriate preventive dentistry should be considered before treatment, especially for patients also treated with an intravenous bisphosphonate.
Live attenuated vaccines: avoid use in those who are clinically immunosuppressed Link Healthcare professionals working in primary and secondary care should ensure that clinically significant immunosuppression in a patient is identified before administration of a live attenuated vaccine.
Meprobamate: licence to be cancelled Link Following an EU wide review of meprobamate, the remaining licence holder in the UK has ceased manufacturing and the licence will be cancelled by the end of 2016.
Paraffin-based skin emollients on dressings or clothing: fire risk Link Smoking or a naked flame could cause patients' dressings or clothing to catch fire when being treated with paraffin-based emollient that is in contact with the dressing or clothing.
Letters sent to healthcare professionals in March 2016 Link In March 2016, letters were sent regarding SGLT2 inhibitors, insulin lispro, natalizumab, noradrenaline, radium-223 dichloride, aflibercept and idelalisib.

March 2016
Trametinib (Mekinist▼): risk of gastrointestinal perforation and colitis Link Use trametinib, authorised either as monotherapy or combined with dabrafenib, with caution in patients with risk factors for gastrointestinal perforation.
Letters sent to healthcare professionals in February 2016 Link In February 2016, a letter was sent to healthcare professionals regarding medicines containing valproate.

February 2016
Valproate and of risk of abnormal pregnancy outcomes: new communication materials Link Children exposed to valproate in utero are at high risk of developmental disorders and congenital malformations.
Spironolactone and renin-angiotensin system drugs in heart failure: risk of potentially fatal hyperkalaemia Link Monitoring of blood electrolytes is essential in patients coprescribed a potassium-sparing diuretic and an angiotensin converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB) for heart failure.
Letters sent to healthcare professionals in January 2016 Link In January 2016, letters were sent to healthcare professionals regarding fingolimod (Gilenya▼) and erlotinib (Tarceva)

January 2016
Nicorandil (Ikorel): now second-line treatment for angina - risk of ulcer complications Link Updated advice on use of nicorandil as second-line treatment for stable angina - some ulcers may progress to complications unless treatment is stopped.
Levonorgestrel-releasing intrauterine systems: prescribe by brand name Link Levonorgestrel-releasing intrauterine systems should always be prescribed by brand name because products have different indications, durations of use, and introducers.
Thalidomide: reduced starting dose in patients older than age 75 years Link Use a lower starting dose of thalidomide in patients with untreated multiple myeloma who are older than age 75 years.
Mycophenolate mofetil, mycophenolic acid: new pregnancy-prevention advice for women and men Link Mycophenolate mofetil and its active metabolite mycophenolic acid are associated with a high rate of serious birth defects and increased risk of spontaneous abortion.
Bisphosphonates: very rare reports of osteonecrosis of the external auditory canal Link Osteonecrosis of the external auditory canal has been reported very rarely (fewer than 1 in 10 000 patients) with bisphosphonates, mainly in association with long-term therapy (2 years or longer).
Antiretroviral medicines: updated advice on body-fat changes and lactic acidosis Link With the exception of medicines containing zidovudine, stavudine, or didanosine, product information will no longer include warnings on fat redistribution or lactic acidosis.
Letters sent to healthcare professionals in November 2015 Link In November, letters were sent regarding thalidomide, mycophenolate mofetil, nicorandil, InductOs, and dimethyl fumarate

November 2015
Crizotinib (Xalkori▼): risk of cardiac failure Link There have been reports of severe, sometimes fatal, cases of cardiac failure in patients treated with crizotinib
Vemurafenib (Zelboraf▼): risk of potentiation of radiation toxicity Link Prescribers should be aware of the risk of potentiation of radiation toxicity with vemurafenib when given before, during, or after radiotherapy
Letters sent to healthcare professionals in October 2015 Link In October 2015, letters were sent to healthcare professionals to provide safety information for the anticancer medicines crizotinib and vemurafenib

October 2015
Mirabegron (Betmiga▼): risk of severe hypertension and associated cerebrovascular and cardiac events Link Mirabegron is now contraindicated in patients with severe uncontrolled hypertension; advice about regular monitoring is being introduced because of cases of severe hypertension.
Letters sent to healthcare professionals in September 2015 Link A letter was sent to healthcare professionals about mirabegron for symptomatic treatment of urgency, increased micturition frequency, or urgency incontinence.

September 2015
Proton pump inhibitors: subacute cutaneous lupus erythematosus Link Proton pump inhibitors (PPIs) are associated very infrequently with cases of subacute cutaneous lupus erythematosus (SCLE), a non-scarring dermatosis that can develop in sun-exposed areas. If a patient treated with a PPI develops lesions-especially in sun-exposed areas of the skin-and it is possibly accompanied by arthralgia, they should be advised to avoid exposure of the skin to sunlight. The PPI should be stopped unless it is imperative for a serious acid-related condition. Furthermore, a patient who develops SCLE with a particular PPI may be at risk of the same reaction with another.
Download the Yellow Card mobile app to report suspected adverse drug reactions Link On 14 July 2015, the Yellow Card mobile app was launched - use it to report suspected reactions and receive up to date information on your medicines of interest.
Pseudoephedrine and ephedrine: update on managing risk of misuse in the UK Link Implementation of measures to regulate sales, together with the additional voluntary actions overseen by the pharmacy profession, has made an important contribution to managing the risk of misuse of pseudoephedrine and ephedrine in the UK.
Letters sent to healthcare professionals in August 2015 Link A letter was sent regarding InductOs (solvent and matrix for implantation) to inform of a potential shortage.

August 2015
Simeprevir with sofosbuvir: risk of severe bradycardia and heart block when taken with amiodarone Link Avoid concomitant use of amiodarone with simeprevir (Olysio▼) and sofosbuvir (Sovaldi▼) combination therapy, unless other antiarrhythmics cannot be given.
Denosumab (Xgeva▼, Prolia); intravenous bisphosphonates: osteonecrosis of the jaw-further measures to minimise risk Link Patient reminder cards about the risk of osteonecrosis of the jaw are being introduced; denosumab 120 mg is now contraindicated in patients with unhealed lesions from dental or oral surgery.
Latanoprost (Xalatan): increased reporting of eye irritation since reformulation Link Advise patients to tell their health professional if they experience severe eye irritation.
SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin): risk of diabetic ketoacidosis Link Test for raised ketones in patients with acidosis symptoms, even if plasma glucose levels are near-normal.
High-dose ibuprofen (≥2400mg/day): small increase in cardiovascular risk Link EU review confirms that the cardiovascular risk of high-dose ibuprofen (?2400mg/day) is similar to COX 2 inhibitors and diclofenac.
Intrauterine contraception: uterine perforation-updated information on risk factors Link The most important risk factors for uterine perforation are insertion during lactation and insertion in the 36 weeks after giving birth.
Survey of medicines safety communications Link Please complete our survey on how we communicate medicines safety issues.
Hormonal pregnancy tests and birth defects: call for evidence Link A group of independent experts will review all evidence provided; we will publish a report of the group's findings.
Sofosbuvir with daclatasvir; sofosbuvir and ledipasvir: risks of severe bradycardia and heart block when taken with amiodarone Link Avoid concomitant use of amiodarone (Cordarone X) with ledipasvir-sofosbuvir (Harvoni▼), and amiodarone with sofosbuvir (Sovaldi▼) and daclatasvir (Daklinza▼), unless other antiarrhythmics cannot be given.
Pomalidomide (Imnovid▼): risks of cardiac failure, interstitial lung disease and hepatotoxicity Link New monitoring instructions to detect these side effects as soon as possible.
Epoetin beta (NeoRecormon): increased risk of retinopathy in preterm infants cannot be excluded Link Possible increased risk of retinopathy with epoetin beta in premature infants calls for careful consideration of options for preventing anaemia of prematurity.
Letters sent to healthcare professionals in April 2015 Link Last month, letters were sent regarding ketoprofen gel, fingolimod (Gilenya▼) and efavirenz (Sustiva).

April 2015
Hydroxyzine (Atarax, Ucerax): risk of QT interval prolongation and Torsade de Pointes LinkThe maximum adult daily dose of hydroxyzine is now 100 mg.
Codeine for cough and cold: restricted use in children LinkDo not use codeine in children under 12 as it is associated with a risk of respiratory side effects.
High strength, fixed combination and biosimilar insulin products: minimising the risk of medication error LinkSeveral new high strength insulin products are now on the market.
Letters sent to healthcare professionals in March 2015 LinkLast month, letters were sent regarding ketoconazole HRA and radium-223 dichloride (Xofigo).

March 2015
Dimethyl fumarate (Tecfidera): fatal PML in an MS patient with severe, prolonged lymphopenia LinkCheck full blood counts before prescribing dimethyl fumarate and then every 6 to 12 months. Stop treatment immediately if you suspect progressive multifocal leukoencephalopathy.
Ferumoxytol (Rienso) intravenous iron no longer available for use LinkThe licence-holder of ferumoxytol has voluntarily withdrawn it from the UK market for commercial reasons.
Corticosteroids e-learning module launched LinkThe new online learning module on corticosteroids helps clinicians understand how to identify, manage and avoid the important side effects of these valuable and widely prescribed medicines-vital knowledge for optimising the use of corticosteroids.
Report misleading medicines advertisements LinkIf you are concerned about advertising you see for a medicine, please report it to the MHRA or industry self-regulatory body.
Tiotropium delivered via Respimat compared with Handihaler: no significant difference in mortality in TIOSPIR trial LinkTake the risk of cardiovascular side effects into account when prescribing tiotropium delivered via Respimat or Handihaler to patients with certain cardiac conditions, who were excluded from clinical trials of tiotropium (including TIOSPIR).
INOmax (nitric oxide) cylinders: valve defect might stop gas delivery early in some cylinders LinkWhile this defect is still being investigated, we remind you to always have a full spare cylinder loaded on the delivery device so the cylinders can be switched without delay.
Drugs and driving: blood concentration limits set for certain drugs LinkWe remind you that a new offence will be enforced from 2 March 2015 in England and Wales.
Letters sent to healthcare professionals since November 2014 LinkSince November 2014, letters were sent regarding vismodegib (Erivedge ▼), chlorhexidine solutions, carbocisteine oral liquid (Mucodyne Paediatric 125mg/5ml), regadenoson (Rapiscan), a parenteral nutrition emulsion (Triomel), and telavancin (Vibativ▼).

November 2014 and earlier
Medicines related to valproate: risk of abnormal pregnancy outcomes LinkChildren exposed in utero to valproate are at a high risk of serious developmental disorders (in up to 30-40% of cases) and/or congenital malformations (in approximately 10% of cases).
Ustekinumab (Stelara): risk of exfoliative dermatitis LinkIf you suspect exfoliative dermatitis caused by an adverse drug reaction to ustekinumab, stop treatment.
Mycophenolate mofetil (CellCept) and mycophenolic acid: risk of hypogammaglobulinaemia and risk of bronchiectasis LinkMeasure serum immunoglobulin levels if recurrent infections develop.
Oral diclofenac no longer available without prescription LinkOral diclofenac is associated with a small increased risk of cardiovascular side effects and is therefore no longer available over the counter.
Aceclofenac (Preservex): updated cardiovascular advice in line with diclofenac and COX-2 inhibitors LinkAceclofenac is now contraindicated in patients with certain established cardiovascular diseases.
Yellow Card extended to include devices, counterfeits and defective medicines LinkWe have simplified our medicine and device incident report systems by bringing them all under the Yellow Card Scheme.
Ivabradine (Procoralan) in the symptomatic treatment of angina: Link Ivabradine may be associated with the risks of bradycardia, atrial fibrillation, and other cardiovascular risks. Only start ivabradine if the resting heart rate is at least 70 beats per minute.
Isotretinoin (Roaccutane): Link Following a review of the latest evidence of an association between isotretinoin and psychiatric disorders, we remind you to monitor all patients for signs of depression and refer for appropriate treatment if necessary. Warn patients and their family that isotretinoin might cause psychiatric disorders and tell them to watch out for symptoms
Hydroxyethyl starch intravenous infusions to be used only in patients with acute blood loss and when crystalloids alone are not sufficient Link The licences of all hydroxyethyl starch (HES) products were suspended in the UK in June 2013. A European regulatory review of the benefits and risks of HES has since been completed.
Hydrogen peroxide: Link There have been life threatening and fatal cases of gas embolism with use of hydrogen peroxide during surgery. We remind you that hydrogen peroxide must not be used during surgery
Veletri (epoprostenol) powder for solution for infusion: Link There have been reports of reconstituted solution leaking from some models of extension sets and pumps. The administration accessories listed below have been shown to be compatible with Veletri
Agomelatine (Valdoxan): Link Agomelatine (Valdoxan) may cause liver toxicity in some people. Test liver function before and during treatment.
Colobreathe (colistimethate sodium dry powder for inhalation): Link We have received reports of Colobreathe (colistimethate sodium) capsules shattering when pierced by their inhaler device. The instructions for inhaler use have been revised to reduce this risk.
Boceprevir (Victrelis) and telaprevir (Incivo): Link Boceprevir and telaprevir are not recommended for patients who have a low platelet count or hypoalbuminaemia before starting either of these medicines. Boceprevir is also not recommended for patients who have coagulopathy before starting it.
Ponatinib (Iclusig▼): risk of vascular occlusive events Link An in-depth EU review of this risk has now been completed.
Chlorhexidine solutions: Link Use the minimum amount of chlorhexidine solution required and do not allow the solution to pool. Remove any excess solution and any soaked materials, drapes, or gowns from the skin.
Desiccants in Blister Packs: Link Take care to tell people receiving blister packs containing a desiccant that the desiccant should not be swallowed.
Interferon-Beta Link There have been reports of thrombotic microangiopathy and nephrotic syndrome linked to interferon beta treatment. Be vigilant for early signs or symptoms of these conditions (see below) and treat these conditions promptly if they occur.
Dexamethasone Injection Link From October 2014 Dexamethasone 4 mg/ml injection (Organon Laboratories Limited) will be replaced with a new formulation called Dexamethasone 3.8 mg/ml solution for injection (Aspen Pharma Trading Limited).
Basiliximab Link In clinical trials, serious cardiac side effects were observed more frequently with basiliximab than with other induction agents.
Drugs and Driving Link This new offence will be enforceable in England, Wales, and Scotland but not Northern Ireland where the introduction of a similar offence is under consideration.
Ferumoxytol Link New recommendations are being introduced to minimise the risk of serious hypersensitivity reactions with ferumoxytol. These include a contraindication in patients with any drug allergies and changes in the method of administration
Denosumab Link Denosumab is associated with a risk of osteonecrosis of the jaw (ONJ) and with a risk of hypocalcaemia. Before starting denosumab treatment, a dental examination and appropriate preventive dentistry are now recommended to reduce the risk of osteonecrosis of the jaw (ONJ).
Nitrofurantoin Link Nitrofurantoin is now contraindicated in patients with an estimated glomerular filtration rate (eGFR) of less than 45 ml/min/1.73m2.
Yellow Card Scheme Update Link We are publishing new guidelines for reporting suspected adverse drug reactions (ADRs) in children and adolescents aged under 18 years via the Yellow Card Scheme.
Domperidone Link Domperidone should no longer be sold to anyone without a prescription. It is associated with a small increased risk of serious cardiac side effects.
Ofatumumab Link Serious and fatal infusion reactions have occurred with ofatumumab and other anti-CD20 monoclonal antibodies. We remind you to always give premedication before each ofatumumab infusion. If a severe reaction occurs, interrupt ofatumumab infusion and treat the reaction. Patients with a history of decreased pulmonary function are at high risk of pulmonary complications from severe reactions
Levonorgestrel and ulipristal Link Emergency contraceptives remain suitable for all women regardless of the woman's weight or body mass index (BMI). Emergency contraceptives should be used as soon as possible after unprotected sex or contraceptive failure to prevent unintended pregnancy
Drugs for Infusion Link Take care to ensure that checking procedures are in place to reduce the risk of administration errors with drugs for infusion.
Fentanyl Transdermal Patches Link Accidental exposure to transdermal fentanyl can occur if a patch is swallowed or transferred to another individual.
Link Some newly issued vials of intravenous dantrolene may contain crystals of undissolved dantrolene sodium following reconstitution. Draw up the reconstituted solution with a filter needle to prevent these crystals from being administered to patients.
Drugs and Driving Link The Department for Transport has introduced a new offence of driving with certain controlled drugs above specified limits in the blood; this is likely to come into force on 2 March 2015. The list of drugs includes some licensed medicines.
Chlorhexidine Solution in Premature Infants Link We have received reports of serious side effects in premature infants who were treated with chlorhexidine solution before central venous catheterisation.
Ivabradine Link Preliminary results have shown a small increase in the combined risk of cardiovascular death and non-fatal myocardial infarction with ivabradine compared with placebo in a subgroup of the SIGNIFY trial.
Renin-angiotensin system blocking agents Link Combination use of medicines from different classes of renin-angiotensin system blocking agents is associated with an increased risk of hyperkalaemia, hypotension, and impaired renal function. New warnings have been agreed following an EU-wide review.
Ferumoxytol Link New data on serious hypersensitivity reactions following ferumoxytol administration are currently being reviewed by the European Medicines Agency. We remind you of the current measures to take to manage and minimise the risk of hypersensitivity reactions with any intravenous iron product
Statins Link Please refer to the full article. The benefits of using any statin in its licensed indication outweigh the risks in most patients. As with all medicines, the MHRA constantly reviews the safety of statins and will inform prescribers and patients when new important information becomes available. In deciding whether to offer statin therapy, carefully consider both the potential benefits and harms for each patient.
Zolpidem Link Zolpidem (Edluar, Stilnoct) is used to treat insomnia. Taking zolpidem is associated with a risk of impaired driving ability the next day. To reduce this risk, advise patients:
  • to take 10 milligrams of zolpidem at bedtime and not to take it again the same night
  • not to drive, operate machinery, or work at heights until at least 8 hours after taking zolpidem
  • not to take zolpidem with alcohol, illicit drugs, or other central nervous system suppressants
  • not to drive, operate machinery or work at heights if they are still drowsy after taking Zolpidem
People with liver impairment and the elderly should take no more than 5 milligrams of zolpidem a night.
Adrenaline Auto-Injectors (Jext®, EpiPen® or Emerade®) Link People who have been prescribed an adrenaline auto-injector because of the risk of anaphylaxis should carry two with them at all times for emergency, on-the-spot use. After every use of an adrenaline auto-injector, an ambulance should be called (even if symptoms are improving), the individual should lie down with their legs raised and, if at all possible, should not be left alone
Voriconazole Link Voriconazole (Vfend) is known to be associated with a risk of liver toxicity, phototoxicity, and squamous cell carcinoma of the skin. Test liver function before starting treatment with voriconazole and at least weekly during the first month of treatment. Tell patients to avoid sunlight exposure while taking voriconazole. New tools to help monitor and manage these risks are being distributed
Domperidone Link Domperidone (Motilium) is associated with a small increased risk of serious cardiac side effects. Its use is now restricted to the relief of nausea and vomiting and the dosage and duration of use have been reduced. It should no longer be used for the treatment of bloating and heartburn. Domperidone is now contraindicated in those with underlying cardiac conditions and other risk factors (see below). Patients with these conditions and patients receiving long-term treatment with domperidone should be reassessed at a routine appointment, in light of the new advice
Tumour necrosis factor alpha inhibitors - Adalimumab, Certolizumab, Etanercept, Golimumab, and Infliximab Link There is an increased risk of tuberculosis, or reactivation of latent tuberculosis, during treatment with tumour necrosis factor alpha (TNF-alpha) inhibitors. Tuberculosis in patients receiving TNF-alpha inhibitors can be life-threatening, and deaths from tuberculosis have occurred in these patients. TNF-alpha inhibitors are therefore contraindicated in patients with active tuberculosis or other severe infections. Screen patients for active and latent tuberculosis before starting treatment with a TNF-alpha inhibitor. Monitor them closely for infectious diseases including tuberculosis before, during, and after treatment

The TNF-alpha inhibitors authorised in the UK are adalimumab, certolizumab, etanercept, golimumab, and infliximab.
Dorzolamide hydrochloride / timolol maleate (Cosopt) preservative-free eye drops Link In December 2013 the MHRA reported eye injuries caused by the pipette design of Cosopt preservative-free eye drops. Because of these injuries, a new pipette design was introduced in February 2014 as an interim measure. The instructions for using the new design are enclosed in the product packaging. The old pipette design is now being withdrawn. Please see further guidance on the MHRA website, including an updated Patient Information Leaflet and detailed instructions for use.
Methysergide Link Methysergide (Deseril) should only be used for the prophylactic treatment of severe intractable migraine and episodic and chronic cluster headache in adults when treatment with standard medicines has failed. Treatment should be initiated and supervised by specialists.
Strontium Ranelate Link The European Medicines Agency (EMA) has concluded its review of the risks and benefits of strontium ranelate (Protelos). The EMA considered that strontium ranelate should only be used by people for whom there are no other treatments for osteoporosis. The cardiovascular risks identified with strontium ranelate may be sufficiently reduced in this population by restricting its use to people without cardiovascular contraindications (as advised in April 2013) and by monitoring cardiovascular risk regularly.
St John's Wort Link St John's wort interacts with hormonal contraceptives. This interaction reduces the effectiveness of these contraceptives and increases the risk of unplanned pregnancy. This applies to all hormonal contraceptives except intrauterine devices, for which there are currently no data
Orlistat Link Orlistat may theoretically reduce the absorption of antiretroviral HIV medicines. Initiate orlistat treatment only after careful consideration of the possible impact on efficacy of antiretroviral HIV medicines. People who take antiretroviral HIV medicines should consult their doctor before taking non-prescription 60 mg orlistat
Combined Hormonal Contraceptives Link
Link
Combined hormonal contraceptives and venous thromboembolism: review confirms risk is small-consider risk factors and remain vigilant for signs and symptoms

Please note: The second update refers to a correction made to the original guidance.
Capecitabine Link Severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported during treatment with capecitabine. Some cases were fatal.
Temozolomide Link Hepatic injury, including hepatic failure with fatal outcome, has been reported in patients treated with temozolomide. Liver function should be tested before and during treatment with temozolomide.
Ofatumumab Link All patients should be screened for hepatitis B virus infection before starting treatment with ofatumumab. Patients with active infection with this virus should not be treated with ofatumumab.
Prasugrel (Efient) Link New clinical trial information is available on the timing of the loading dose of prasugrel when used in patients with unstable angina or non-ST segment elevation myocardial infarction. In these patients, when coronary angiography is done within 48 hours after admission, the loading dose should only be given at the time of percutaneous coronary intervention.
Recombinant interferon-beta: thrombotic microangiopathy Link We are investigating a cluster of reports of thrombotic microangiopathy with recombinant interferon-beta.
Rituximab Link Screening for hepatitis B virus is now recommended in all patients (not only those at risk of this infection) before starting treatment for all indications. A patient with positive serology for hepatitis B virus should be referred to a specialist in liver disease before starting treatment with rituximab.
Clopidogrel Link Reports of acquired haemophilia have been received in association with clopidogrel. This very rare but serious condition may be missed due to the established risk of bleeding associated with clopidogrel treatment.
Dorzolomide hydrochloride/timolol maleate (Cosopt) preservative-free single-dose eye drops Link We are aware of 69 complaints in the UK with this product after the introduction of a new design of dropper in July 2013.
Ponatinib (Iclusig ▼) Link A review of the latest data has been conducted after new information suggested that vascular occlusive events occur at a higher cumulative incidence than initially observed at the time of licensing.
Antiepileptic drugs Link New advice on switching between different manufacturers' products for a particular drug
Sodium valproate (Epilim®) Link Sodium valproate: special reminder on risk of neurodevelopmental delay in children following maternal use—not for use in pregnancy unless there is no effective alternative
Risperidone and paliperidone Link Risperidone and paliperidone: risk of intraoperative floppy iris syndrome in patients undergoing cataract surgery
Short-acting ß2 agonists: Terbutaline Link Restricted use for tocolysis in premature labour
Apixaban, Dabigatran and Rivaroxaban: Link New oral anticoagulants apixaban (Eliquis▼), dabigatran (Pradaxa) and rivaroxaban (Xarelto▼): risk of serious haemorrhage-clarified contraindications apply to all three medicines
Filgrastim and Pegfilgrastim Link Filgrastim and Pegfilgrastim: risk of potentially life-threatening capillary leak syndrome
Intravenous Iron Link Intravenous iron and serious hypersensitivity reactions: clarification of advice on new recommendations regarding initial test dose
Diclofenac Link Patients with serious underlying heart conditions, such as heart failure, heart disease, circulatory problems or a previous heart attack or stroke should no longer use diclofenac .
Codeine Link Codeine-containing medicines should only be used in children over 12 years old to treat acute (short lived) moderate pain, and only if it cannot be relieved by other painkillers such as paracetamol or ibuprofen.
Nitrofurantoin Link Nitrofurantoin: reminder on precautions for use, especially renal impairment in (elderly) patients
Metoclopramide Link Metoclopramide: risk of neurological adverse effects-restricted dose and duration of use
Ondansetron Link Ondansetron for intravenous use: dose-dependent QT interval prolongation-new posology
Intravenous iron Link Intravenous iron and serious hypersensitivity reactions: new strengthened recommendations to manage and minimise risk
Caffeine Link Caffeine for apnoea of prematurity: all products to be named and prescribed as caffeine citrate
Hydroxyethyl starch intravenous infusion Link Hydroxyethyl starch intravenous infusion: suspension of licences
Diclofenac Link Diclofenac: new contraindications and warnings after a Europe-wide review of cardiovascular safety
Oral retinoids Link Oral retinoids: pregnancy prevention-reminder of measures to minimise teratogenic risk
Tolvaptan (Samsca▼) Link Tolvaptan (Samsca▼): risk of liver injury-liver-function testing recommended in patients with symptoms that may indicate liver injury
Thalidomide Link Thalidomide: risk of second primary malignancies
Insulin degludec (Tresiba▼) Link Insulin degludec (Tresiba▼): available in additional higher strength than existing insulins-care needed to minimise risk of error, including training for patients
Cilostazol (Pletal) Link Cilostazol (Pletal): risks of cardiovascular and bleeding events-indication restricted to second-line treatment and contraindicated with some cardiovascular conditions and medicines
Strontium ranelate (Protelos) Link Strontium ranelate (Protelos): risk of serious cardiac disorders-restricted indications, new contraindications, and warnings
Dabigatran (Pradaxa) Link Dabigatran (Pradaxa): contraindicated in patients with prosthetic heart valve(s) requiring anti-coagulant treatment, because of the risk of thrombosis and haemorrhage
Aqueous cream Link Aqueous cream: may cause skin irritation, particularly in children with eczema, possibly due to sodium lauryl sulphate content
Botulinum toxin type B (Neurobloc) Link Botulinum toxin type B (Neurobloc): serious known risks such as toxin spread reported mostly with off-label use
Denosumab 60 mg (Prolia▼) Link Denosumab 60 mg (Prolia▼): rare cases of atypical femoral fracture with long-term use
Sprayable fibrin sealants (Evicel, Tisseel and Artiss) Link Sprayable fibrin sealants (Evicel, Tisseel and Artiss): updated guidance on minimising risk of life-threatening and fatal air embolism
Fingolimod (Gilenya▼) Link Fingolimod (Gilenya▼): bradycardia and heart block - repeat enhanced cardiovascular monitoring when restarting fingolimod after treatment interruption
Lenalidomide (Revlimid) Link Lenalidomide (Revlimid): risk of serious hepatic adverse drug reactions - routine monitoring of liver function now recommended
Tredaptive (combined niacin-laropiprant) Link Tredaptive (combined niacin-laropiprant): no longer for prescribing as preliminary HPS2-THRIVE trial failed to show benefit outweighs risks
Roflumilast (Daxas▼) Link Roflumilast (Daxas▼): risk of suicidal behaviour - avoid use in patients with previous or existing psychiatric symptoms and discontinue treatment if new or worsening psychiatric symptoms occur
Carbamazepine, oxcarbazepine and eslicarbazepine Link Carbamazepine, oxcarbazepine and eslicarbazepine: potential risk of serious skin reactions associated with the HLA-A* 3101 allele
Codeine-containing pain relief in children Link Codeine-containing pain relief in children: safety review initiated following post-surgical fatalities in ultra-rapid metabolisers
Evicel fibrin sealant spray application Link Evicel fibrin sealant spray application: life-threatening and fatal air embolism - updated advice on minimising risk
Agomelatine (Valdoxan / Thymanax) Link Agomelatine (Valdoxan/ Thymanax): risk of dose-related hepatotoxicity and liver failure - updated warnings and monitoring guidance.
Denosumab Link Denosumab: fatal cases of severe symptomatic hypocalcaemia, and risk of hypocalcaemia at any time during treatment - monitoring recommended
Intravenous 0.18% saline/4% glucose solution ('hypotonic saline') Link Intravenous 0.18% saline/4% glucose solution ('hypotonic saline') in children: reports of fatal hyponatraemia - do not use in children aged 16 years or less, except in specialist settings under expert medical supervision
Domperidone Link Domperidone: small risk of serious ventricular arrhythmia and sudden cardiac death
Strontium Link Strontium ranelate (Protelos): Should not be used in patients with current or previous venous thromboembolism (VTE) or temporary or permanent immobilisation because of risk of VTE. Rare serious skin reactions may occur within the first weeks of treatment.
Proton pump inhibitors Link Proton pump inhibitors in long-term use: Recent epidemiological evidence of increased risk of fracture
Proton pump inhibitors Link Proton pump inhibitors in long-term use: reports of hypomagnesaemia
Patent Blue dye Link Blue dyes: risk of serious allergic reactions
Atomoxetine Link Atomoxetine (Strattera▼): Increases in blood pressure and heart rate - new contraindications, warnings and advice for monitoring
Statins Link Statins: risk of hyperglycaemia and diabetes
Dabigatran Link MHRA Safety Update - Dabigatran (Pradaxa▼): Risk of serious haemorrhage - need for renal function testing
Citalopram Link MHRA Safety Update - Citalopram and escitalopram: QT interval prolongation - new maximum daily dose restrictions (including in elderly patients), contraindications, and warnings) and then the same for the following…..
Lenalidomide Link Lenalidomide (Revlimid▼): Risk of second primary malignancy-update
Link Lenalidomide: Risk of thrombosis and thromboembolism
Midazolam (buccal) Link Buccal midazolam (Buccolam▼): New authorised medicine for paediatric use - care needed when transferring from unlicensed formulations
Adcal D3, Calcium / colecalciferol Link Calcium and vitamin D: Studies of cardiovascular risk do not support prescribing changes
Pioglitazone Link Pioglitazone: Risk of bladder cancer
Link Insulin combined with pioglitazone: Risk of cardiac failure
Thalidomide Link Thalidomide: Risk of arterial and venous thromboembolism
Paracetamol Link Paracetamol: Updated dosing for children to be introduced
Bisphosphonates Link Bisphosphonates: Atypical femoral fractures
Yasmin®, ethinyloestradiol / drospirenone Link Yasmin: Risk of venous thromboembolism higher than levonorgestrel-containing pills
Prasugrel Link Prasugrel (Efient▼): Rare but serious hypersensitivity reactions
Modafinil Link Modafinil (Provigil): Information to support safer use; now restricted to narcolepsy
Daptomycin Link Daptomycin: Risk of eosinophilic pneumonia
Omalizumab Link Omalizumab: Potential risk of arterial thrombotic events
Fusidic acid, Sodium fusidate, Statins Link Systemic fusidic acid and interaction with statins: Risk of rhabdomyolysis
Antipsychotics Link Antipsychotics: Use during third trimester of pregnancy and extrapyramidal effects or withdrawal symptoms in newborns
Pseudoephedrine Link Pseudoephedrine and ephedrine: Update on managing risk of misuse
Stavudine Link Stavudine (Zerit): Use only when there are no appropriate alternatives, and for the shortest possible time
Atypical antipsychotics Link Atypical (second-generation) antipsychotics: Reminder to monitor and manage weight, glucose, and lipid levels
Tigecycline Link Tigecycline (Tygacil▼): Increased mortality in clinical trials - use only when other antibiotics are unsuitable