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A new study has suggested pregabalin may slightly increase the risk of major congenital malformations if used in pregnancy. Patients should continue to use effective contraception during treatment and avoid use in pregnancy …
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Recent information relating to COVID-19 vaccines and medicines that has been published since the March 2022 issue of Drug Safety Update, up to 14 April 2022.
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices. Includes a recent recall of Accuretic (quinapril hydrochloride and hydrochlorothiazide).
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Liver monitoring requirements for cladribine in the treatment of multiple sclerosis have been introduced following uncommon cases of serious liver injury. Advise patients to seek urgent medical attention if they develop any …
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Recent information relating to COVID-19 vaccines and medicines that has been published since the February 2022 issue of Drug Safety Update, up to 11 March 2022
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As the safety of COVID-19 antivirals in pregnancy has not been established, please report any pregnancies which occur during use of an antiviral, including paternal use, to the UK COVID-19 Antivirals Pregnancy Registry. This…
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Carefully consider the benefits and risks before prescribing systemic azithromycin or other systemic macrolide antibiotics (erythromycin or clarithromycin) to patients being treated with hydroxychloroquine or chloroquine. An…
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Recent information relating to COVID-19 vaccines and medicines that has been published since the January 2022 issue of Drug Safety Update, up to 11 February 2022.
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A summary of recent letters, medicine recalls and notifications sent to healthcare professionals.
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Albumin-bound paclitaxel formulations for infusion (nab-paclitaxel; brand names Abraxane, Pazenir) differ from conventional paclitaxel medicines in their authorised indications, pharmacokinetics, recommended dosages, and pre…
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Recent information relating to COVID-19 vaccines and medicines that has been published since the December 2021 issue of Drug Safety Update, up to 13 January 2022.
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A summary of recent letters, medicine recalls and notifications sent to healthcare professionals.
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We remind healthcare professionals that elderly patients are at an increased risk of adverse neurological and cardiac effects when being treated with haloperidol for delirium. The lowest possible dose of haloperidol should b…
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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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Recent information relating to COVID-19 vaccines and medicines that has been published since the November 2021 issue of Drug Safety Update, up to 3 December 2021.
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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, medicine recalls and notifications sent to healthcare professionals.
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The paediatric indication for chloral hydrate (for children aged 2 years and older) and cloral (previously chloral) betaine (children aged 12 years and older) has been restricted to short-term treatment (maximum 2 weeks) of …
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A summary of recent letters, medicine recalls and notifications sent to healthcare professionals.
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Rarely, severe adverse effects can occur on stopping treatment with topical corticosteroids, often after long-term continuous or inappropriate use of moderate to high potency products. To reduce the risks of these events, pr…
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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, medicine recalls and notifications sent to healthcare professionals
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Following a review of the available toxicological data and a calculation of daily exposure to boron from a typical dosing regimen, we have concluded that the balance between the benefits and risks of chloramphenicol eye drop…
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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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A summary of letters and drug alerts recently sent to healthcare professionals.
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Cases of interstitial lung disease and pneumonitis have been reported in patients receiving CDK4/6 inhibitors indicated for some breast cancers. Ensure that patients taking these medicines are aware of the need to seek …
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Cases of severe cutaneous adverse reactions, including Stevens-Johnsons syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in patients treated with immune-stimulatory anti-cancer drugs, including atezoli…
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We inform healthcare professionals of the recent campaign to promote awareness of the risk and new resources available to support safe use following previous advice to health and care professionals.
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A summary of letters and recent medicine recalls and notifications sent to healthcare professionals.
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A summary of letters and recent medicine recalls and notifications sent to healthcare professionals.
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Periodically perform skin examinations in patients on bendamustine-containing regimens and consider PML in the differential diagnosis for patients on bendamustine with new or worsening neurological, cognitive, or behavioural…
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A summary of letters and drug alerts recently sent to healthcare professionals.
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Pregabalin has been associated with infrequent reports of severe respiratory depression, including some cases without the presence of concomitant opioid medicines. Patients with compromised respiratory function, respiratory …
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A summary of letters and drug alerts recently sent to healthcare professionals.
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A review of the risks of major congenital malformations and of adverse neurodevelopmental outcomes for antiepileptic drugs by the Commission on Human Medicines has confirmed that lamotrigine (Lamictal) and levetiracetam (Kep…
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The monitoring requirements and discontinuation criteria for dimethyl fumarate (Tecfidera) have been strengthened following a small number of reports of progressive multifocal leukoencephalopathy (PML) in patients with mild …
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Liver monitoring requirements and discontinuation criteria for fingolimod have been updated following reports of serious liver injury. Fatal cases of encephalitis and meningitis caused by herpes simplex and varicella zoster …
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Evidence suggests an increased risk of aminoglycoside-associated ototoxicity in patients with mitochondrial mutations, including cases in which the patient’s aminoglycoside serum levels were within the recommended range. The…
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A summary of letters and drug alerts recently sent to healthcare professionals.
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Fluoroquinolones should only be used after careful benefit-risk assessment and after consideration of other therapeutic options in patients at risk for heart valve regurgitation (incompetence).
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Erythromycin has been associated with events secondary to QT interval prolongation such as cardiac arrest and ventricular fibrillation. Erythromycin should not be given to patients with a history of QT interval prolongation…
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Updates have been made to the magnitude of the known risk of infantile hypertrophic pyloric stenosis following exposure to erythromycin in infancy as a result of new epidemiological data. The risk is particularly increased i…
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A summary of letters and drug alerts recently sent to healthcare professionals.
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Modafinil potentially increases the risk of congenital malformations when used in pregnancy. Modafinil should not be used during pregnancy and women of childbearing potential must use effective contraception during treatment…
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A review is being undertaken by the Medicines and Healthcare products Regulatory Agency with advice from the Commission on Human Medicines and the Isotretinoin Expert Working Group due to concerns about the possible associat…
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A summary of letters and drug alerts recently sent to healthcare professionals.
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Patients with complete or partial dihydropyrimidine dehydrogenase (DPD) deficiency are at increased risk of severe and fatal toxicity during treatment with these medicines. All patients should be tested for DPD deficiency be…
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Flucytosine is a prodrug of 5-fluorouracil used to treat systemic yeast and fungal infections and can cause life-threatening and severe toxicity in patients with complete and partial dihydropyrimidine dehydrogenase (DPD) def…
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Increase the frequency of blood pressure monitoring to at least weekly for the first 2 months, and then monitor monthly for the first year and periodically thereafter during treatment, following recent reports of onset of se…
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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…