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In February 2016, a letter was sent to healthcare professionals regarding medicines containing valproate.
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Children exposed to valproate in utero are at high risk of developmental disorders and congenital malformations. Use the new communication materials below to discuss these risks with patients
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Not for use in pregnancy unless there is no effective alternative.
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Data suggests that long-term use of carbamazepine, phenytoin, primidone, and sodium valproate is associated with decreased bone mineral density that may lead to osteopenia, osteoporosis, and increased fractures.
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Letters were sent about valproate medicines, atezolizumab (Tecentriq▼), and nusinersen (Spinraza▼). MHRA issued alerts and recalls for valsartan-containing medicines, Fiasp FlexTouch pre-filled pens, melatonin capsules, and sodium cromoglicate eye drops.
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Letters were sent to healthcare professionals about Jext adrenaline autoinjectors, rivaroxaban, Ozurdex 700 micrograms intravitreal implant, sildenafil, hydrochlorothiazide, and Epilim Chronosphere (sodium valproate).…
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A clinically significant interaction between carbapenems and valproic acid results in reduced valproate plasma concentrations with potential for inadequate seizure control.…
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…Children 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).…
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Valproate medicines must no longer be used in women or girls of childbearing potential unless a Pregnancy Prevention Programme is in place.…
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…Inform male patients who may father children of this possible increased risk and the recommendation to use effective contraception during valproate treatment and for at least 3 months after stopping valproate.
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In January 2020, healthcare professionals received updated educational materials to support the valproate pregnancy prevention programme. Valproate is contraindicated in girls and women of childbearing potential, unless the conditions of the pregnancy prevention programme are met.…
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices, and a recent National Patient Safety Alert asking organisations to put a plan in place to implement new regulatory measures for valproate.…
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…Three infographics have been developed to provide clarity regarding valproate prescribing.
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…For female patients, healthcare professionals should continue to follow the existing strict precautions related to preventing the use of valproate in pregnancy (Valproate Pregnancy Prevention Programme).…
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In view of data showing ongoing exposure to valproate in pregnancy, this article reminds healthcare professionals of the risks in pregnancy and the current Pregnancy Prevention Programme requirements, and provides information about the potential risks of valproate in other patients following…
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…Women continue to report instances when they have not received patient information with their dispensed valproate medicine.…
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A recent Europe-wide review of the safety information for alli has led to a number of updates, which bring the product information in line with that for Xenical.
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Topiramate is now contraindicated in pregnancy and in women of childbearing potential unless the conditions of a Pregnancy Prevention Programme are fulfilled. This follows a review by the MHRA which concluded that the use of…
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…They also include previous updates to product information on the risk of low birth weight in children exposed to valproate during pregnancy.…
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Valproate medicines must not be used in women of childbearing potential unless the Pregnancy Prevention Programme is in place. If you are involved in the care of female patients on valproate in the UK, see a reminder of actions required for this medicine.…
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…Patient Safety Alerts have now been issued asking all organisations to undertake systematic identification of women and girls taking valproate.…
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New safety and educational materials have been introduced for men and women and healthcare professionals to reduce the harms from valproate, including the significant risk of serious harm to the baby if taken during pregnancy and the risk of impaired fertility in males.…
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Use materials online now and hardcopies arriving over the coming weeks by post to ensure women and girls of childbearing potential on valproate medicines meet the requirements of the Pregnancy Prevention Programme.…
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Ongoing patient survey data suggest that more effort is needed by clinicians to achieve full and timely compliance with the valproate Pregnancy Prevention Programme and meet the goal to rapidly reduce and eventually eliminate the harms of valproate in pregnancy in view of its serious teratogenicity…
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Unless there are exceptional circumstances, valproate-containing medicines must always be dispensed in the manufacturer’s original full pack.…
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Guidance has been published to support initiation of valproate in female patients and for annual review and pregnancy testing during the coronavirus pandemic.…
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Letters were sent about Insuman insulin products, mecasermin, and valproate medicines. Recalls were issued about ranitidine medicines and Paclitaxel.
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We have initiated a new safety review into topiramate as a result of an observational study reporting an increased risk of neurodevelopmental disabilities in children whose mothers took topiramate during pregnancy.
Topir…
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…This review was initiated in the context of the known harms of valproate in pregnancy, which should only be prescribed to women of childbearing potential if there is a pregnancy prevention programme in place.…
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…Letters were sent about methotrexate, modafinil, Ecalta, Picato, Nexplanon, valproate medicines, e-cigarettes, and Lemtrada. Alerts were issued about finasteride, codeine/paracetamol, and Picato.…
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Careful monitoring of serum sodium important, co-administration of other drugs that may increase serum sodium not recommended.
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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Tazocin (piperacillin/tazobactam) has been reformulated to meet European Pharmacopoeia requirements on particle size.
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A summary of letters and recent medicine recalls and notifications sent to healthcare professionals.
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Letters were sent about ibrutinib, daclizumab, aflibercept, valproate medicines, and arsenic trioxide.
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A summary of recent letters, medicine recalls and notifications sent to healthcare professionals.
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Cases of pigmentary maculopathy leading to visual impairment have been reported with pentosan polysulfate, particularly after long-term use at high doses. Ensure patients taking pentosan polysulfate have regular ophthalmic e…
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A summary of recent letters, medicine recalls and notifications sent to healthcare professionals.
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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A summary of letters and drug alerts recently sent to healthcare professionals.
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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We have received reports of Colobreathe (colistimethate sodium) capsules shattering when pierced by their inhaler device.
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Canagliflozin may increase the risk of lower-limb amputation (mainly toes) in patients with type 2 diabetes. Evidence does not show an increased risk for dapagliflozin and empagliflozin, but the risk may be a class effect. P…
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A summary of letters sent to relevant healthcare professionals in December 2016.
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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May cause skin irritation, particularly in children with eczema, possibly due to sodium lauryl sulfate content.
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liver-function testing recommended in patients with symptoms that may indicate liver injury.
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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Letters were sent about Oncaspar▼ (pegaspargase), Ketalar (ketamine) injection, and Elmiron (pentosan polysulfate sodium).…