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Codeine linctus, an oral solution, will now require a prescription in the UK due to concerns about drug dependence, addiction, and overdose. The Medicines and Healthcare products Regulatory Authority (MHRA) made this decision following a public consultation. Codeine linctus is only approved for the treatment of dry cough lasting over 8 weeks, and healthcare professionals are advised to review the product's warnings and contraindications, especially for patients with a history of substance abuse. The recreational use of codeine linctus, particularly in drinks like Purple Drank, Lean, Sizzurp, and Dirty Sprite, poses serious health risks, including addiction, overdose, and even death. All market authorization holders of codeine linctus will update their product licenses within 3 months to reflect the change to prescription-only status. [Extracted from the article]

The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has implemented new safety measures for the use of valproate to reduce the risk of harm to babies if taken during pregnancy and the risk of impaired fertility in males. These measures include restrictions on starting valproate in new patients under 55 years old unless there are no other effective treatments or the reproductive risks do not apply. Women currently taking valproate should be reviewed at their next specialist visit and a second opinion is required for continued treatment. New educational materials have been introduced for healthcare professionals and patients, and it is advised to discuss these measures with healthcare professionals before making any changes to treatment. [Extracted from the article]

The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has introduced new safety and educational materials for patients and healthcare professionals regarding the use of valproate. These materials aim to reduce the risks associated with valproate use, such as congenital abnormalities during pregnancy and impaired fertility in males. Healthcare professionals are advised not to initiate valproate treatment in new male or female patients under 55 years of age unless there are no other effective or tolerated treatments. The Commission on Human Medicines is also considering data suggesting an increased risk of neurodevelopmental disorders in children whose fathers took valproate before conception. The new materials include updated guides for healthcare professionals and patients, an annual risk acknowledgement form, a patient card on contraception and pregnancy prevention, a pharmacy poster, and warning stickers for packaging. [Extracted from the article]

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has implemented new restrictions on the prescribing of systemic fluoroquinolones. These antibiotics should now only be prescribed when other antibacterials are not suitable. The MHRA conducted a review of the current measures to reduce the risk of adverse effects in patients taking fluoroquinolones and found that patients should be advised to stop treatment if they experience serious adverse reactions. Healthcare professionals should also be aware of the risk of suicidal thoughts and behavior. The MHRA has updated the indications for fluoroquinolones and provided more detailed information about potential psychiatric symptoms. [Extracted from the article]

New measures are being implemented in the UK to reduce the serious harms associated with the use of valproate, according to a media release from the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA conducted a review on the risks of valproate use and found that existing regulatory requirements were not consistently followed. The new measures include increased scrutiny of valproate prescribing and a requirement for healthcare organizations to implement a plan to reduce the risks. Valproate should only be used when the benefits outweigh the risks, as there are alternative medications available for epilepsy and bipolar disorder. These measures will be implemented starting in January 2024. [Extracted from the article]

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a warning about falsified versions of the medications Ozempic (semaglutide) and Saxenda (liraglutide) being found in the UK. Healthcare professionals are advised to be vigilant for symptoms of hypoglycemia in patients who may have obtained these falsified products, as they may contain insulin. Patients are urged to obtain prescription medicines from registered pharmacies and to not use products they suspect are falsified. The MHRA has seized a significant number of potentially falsified Ozempic pens and has received reports of patients being hospitalized after using falsified Saxenda or Ozempic pens. Healthcare professionals should quarantine any suspected falsified products and report any adverse reactions via the Yellow Card scheme. [Extracted from the article]

A retrospective study of 1820 patients in the United Kingdom who were treated for symptomatic COVID-19 found that six patients experienced various toxicities while receiving treatment with sotrovimab or molnupiravir. These toxicities included mild confusion, palpitations, itch, shivering, bradycardia with low blood pressure, and lack of efficacy. One patient died despite receiving treatment with molnupiravir. The study did not provide information about the ages or sexes of the patients, the routes of administration, or the duration of treatment before the onset of reactions. [Extracted from the article]

Health Canada has issued a warning to healthcare professionals about the potential risk of medication errors when using UK-authorised potassium chloride in Canada due to a shortage of Canadian-authorised Potassium Chloride for Injection Concentrate. The UK-authorised product has the same active ingredient, concentration, excipients, and dosage form as Canadian-authorised products, but there are differences in labeling and packaging. Health Canada advises that the UK product must be diluted prior to intravenous infusion and lacks distinctive warnings for dilution, increasing the risk of inadvertent administration without dilution. Healthcare professionals are urged to report any serious or unexpected adverse events to Juno Pharmaceuticals or Health Canada. [Extracted from the article]

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has implemented new safety measures for the use of isotretinoin in adolescents. These measures include requiring two independent prescribers to agree on the initiation of isotretinoin in patients under 18, new counseling requirements regarding potential mental health and sexual function side effects, and the assessment and monitoring of mental health and sexual function before and during treatment. Healthcare professionals are advised to review and integrate these measures into their practice. The MHRA emphasizes the importance of counseling patients about the risks and benefits of isotretinoin treatment, and the need for patients of childbearing potential to be enrolled in the Pregnancy Prevention Program. Patients will need to agree to the Acknowledgement of Risk Form in order to receive isotretinoin. [Extracted from the article]

The European Medicines Agency (EMA) has been notified by national authorities that pre-filled pens falsely labelled as Ozempic (semaglutide solution for injection) have been identified at wholesalers in the EU and the UK. Reference 1 EMA alerts EU patients and healthcare professionals to reports of falsified Ozempic pens Internet Document: 18 Oct 2023. [Extracted from the article]

Following changes to the Human Medications Regulations in the UK, valproate-containing medicines are to be dispensed in the manufacturer's original full pack, advises the Medicines and Healthcare products Regulatory Agency (MHRA) and the Department of Health and Social Care. "It is essential that all patients on valproate-containing medicines receive the latest safety information every time their prescription is dispensed", said Dr June Raine, MHRA Chief Executive. [Extracted from the article]

Codeine linctus is currently licensed as a pharmacy medicine in the UK, and is therefore available to purchase over the counter in pharmacies. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has launched public consultation on a proposal to reclassify codeine linctus to prescription-only medicine. [Extracted from the article]

MHRA and Genomics England to launch pioneering resource to better understand how genetic makeup influences the safety of medicines. A genetic biobank has been launched by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Reference 1 Medicines and Healthcare products Regulatory Agency (UK). [Extracted from the article]

General practitioners and pharmacy teams should send the letter "Advice for patients who have been prescribed Emerade auto-injectors" to all patients and carergivers who have been prescribed Emerade auto-injectors. Pharmaswiss Ceska republika and distributor Bausch & Lomb UK are initiating an urgent recall of all batches of unexpired Emerade 500 µg and Emerade 300 µg adrenaline [epinephrine] auto-injectors, advises the UK Medicines and Healthcare products Regulatory Authority (MHRA). The MHRA, in conjunction with the UK Department of Health & Social Care, has established that there are sufficient supplies of alternative auto-injectors to allow for a patient-level recall of Emerade auto-injectors. [Extracted from the article]

Similarly, segmented point regression of age-standardised rates in overall fluoroquinolone use showed no changes in incident fluoroquinolone prescriptions after regulatory interventions across countries. The impact of regulatory interventions to reduce fluoroquinolone use, implemented throughout 2018-2019 by the European Medicines Agency (EMA), had no relevant effects on fluoroquinolone prescribing in primary care in five EU countries and the UK. [Extracted from the article]

Following the conclusion of a review of pholcodine post-marketing safety data by the Medicines and Healthcare products Regulatory Authority (MHRA,) all pholcodine-containing medicines are being recalled and withdrawn from the UK market as a precaution. The impacted pholcodine products include three Boots products, six Thornton & Ross products, five Bell Sons & Company (Druggists) products, two Pinewood Laboratories products, one LCM linctus, and three Glaxosmithkline Consumer Healthcare products. [Extracted from the article]

Overall, 18% of PFDs produced during the study period involved medicines, most commonly opioid analgesics (22%), antidepressants (9.7%), hypnosedatives (9.2%) and anticoagulants (7.3%). Prevention of Future Death (PFD) reports produced by coroners in England and Wales are commonly medicine-related, according to findings of a retrospective case series published in I Drug Safety i . [Extracted from the article]

Reference 1 National Patient Safety Alert: Class 1 Medicines Recall Notification: Recall of Targocid 200mg powder for solution for injection/infusion or oral solution, Aventis Pharma Limited t/a Sanofi, due to the presence of bacterial endotoxins, NatPSA/2022/008/MHRA Internet Document: 26 Oct 2022. Sanofi is recalling two batches of teicoplanin (Targocid 200mg powder for solution for injection/infusion or oral solution) in the UK due to the presence of bacterial endotoxins, reports the Medicines and Healthcare products Regulatory Authority (MHRA). [Extracted from the article]

Reference 1 Class 2 Medicines Recall: Novartis Pharmaceuticals UK, Sandimmun Oral Solution, EL(22)A/40 Internet Document: 3 Oct 2022. One batch of ciclosporin (Sandimmun Oral Solution) is being recalled by Novartis in the UK due to the presence of crystals in the solution, reports the Medicines and Healthcare products Regulatory Agency (MHRA). [Extracted from the article]

However, hydroxyzine initiation did not change in the BC control cohort or the BC advisory cohort. The reduction in hydroxyzine initiation in the UK after the advisory did not differ significantly between patients with versus without risk factors for QT-interval prolongation or TdP. Hydroxyzine initiation decreased in the UK after a safety advisory on the risks of QT-interval prolongation and torsades de pointe (TdP) was published, but did not decrease in British Columbia (BC) after a similar advisory, according to findings of a study published in I Drug Safety i . [Extracted from the article]

Reference 1 Class 2 Medicines Recall: Pfizer Limited, Accuretic 10/12.5 mg film-coated tablets, EL (22)A/16 Internet Document: 30 Mar 2022. Pfizer is voluntarily recalling a batch of quinapril/hydrochlorothiazide [Accuretic] 10/12.5mg tablets as a precautionary measure due to the identification of a nitrosamine impurity exceeding the acceptable limit, reports the UK Medicines and Helathcare products Regulatory Agency (MHRA). [Extracted from the article]

The UK Medicines and Healthcare products Regulatory Agency (MHRA) is advising that Wockhardt UK is recalling a batch of diazepam RecTubes 2.5mg rectal solution PL 29831/0067 due to an out of specification result for assay during routine stability testing. Class 2 Medicines Recall: Wockhardt UK Ltd, Diazepam RecTubes 2.5mg Rectal Solution, EL (22)A/11. [Extracted from the article]

The UK Medicines and Healthcare products Regulatory Agency (MHRA) is advising that SANTEN Oy, trading as Santen UK, is recalling a batch of ciclosporin [IKERVIS] eye drops because particles/crystals of the active ingredient were detected in the product during stability monitoring. Reference 1 Medicines and Healthcare products Regulatory Agency. [Extracted from the article]

Class 2 Medicines Recall: Various Marketing Authorisation Holders and parallel distributor companies, Irbesartan-containing products, EL(21)A/34 Internet Document: 30 Nov 2021. Specific batches of irbesartan [Aprovel] and irbesartan/hydrochlorothiazide [Co-Aprovel] are being recalled by the Marketing Authorisation Holder and parallel distributor companies in the UK due to contamination with an impurity which has mutagenic potential, reports the UK Medicines and Healthcare products Regulatory Authority (MHRA). [Extracted from the article]

The recall, issued by the UK MHRA on 11 November 2021, affects cold & 'flu relief capsules (GSL), various liveries, Wrafton Laboratories Limited, trading as Perrigo. The recall of certain batches of these capsules is due to a labelling error, which states that children aged 12-15 years can take a maximum of up to 12 capsules (3.6g of paracetamol per day) in any 24-hour period. The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has issued a recall of certain batches of cold & 'flu relief capsules at retail level due to a labelling error. [Extracted from the article]

Following a national review of safety and efficacy data, the paediatric indication for chloral hydrate [Welldorm Elixir] and its prodrug cloral betaine [Welldorm tablets] in the UK has been further restricted to only children and adolescents with a suspected or definite neurodevelopmental disorder, and for the shortest possible duration (<2 weeks), advises the Medicines and Healthcare products Regulatory Agency (MHRA). The Commission on Human Medicines recommended that the paediatric indication of chloral hydrate and cloral betaine products should be restricted to use only in those with suspected or definite neurodevelopmental disorders, in whom the benefits of short-term use outweigh any potential risk. [Extracted from the article]

Commonly prescribed menopausal hormonal replacements in the UK are not associated with an increased risk of dementia, but long-term treatment with estrogen/progestogen [estradiol congeners/progesterone congeners] may increase the risk of Alzheimer's disease (AD), according to findings of two nested case-control studies published in the I BMJ i . The study, however, did find associations with increased risk of developing Alzheimer's disease among long term users of oestrogen-progestogen therapies", concluded the authors. Neither estrogen-only treatments nor estrogen/progestogen treatments were associated with a significantly increased risk of dementia. [Extracted from the article]

The MHRA urges professionals to advise their patients to report any suspected adverse reactions via the MHRA Yellow Card Scheme. As a precautionary measure, the UK's MHRA has recalled certain batches of the ciclosporin eye drop emulsion, Ikervis 1 mg/mL, manufactured by Santen Oy (trading as Santen UK Ltd), due to the presence of particles or crystals of the active ingredient ciclosporin. [Extracted from the article]