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MHRA reviews with healthcare professionals on medicines - 0 views

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    Medicines and Healthcare products Regulatory Agency (MHRA) has urged the healthcare professionals to share their views on the consultation on 'how MHRA communicate with healthcare professionals to improve medicines and medical devices' safety'. Through this consultation the agency wants to review its approach to engagement with healthcare professionals to improve the safety of medicines and medical devices. "We want to ensure that healthcare professionals are receiving actionable information and guidance on safe use of medicines and medical devices that they can take into their working practice, providing timely advice to patients," said MHRA. "We need to improve the way we communicate with healthcare professionals. We want to hear from you to enable us to transform how we communicate with you and how we work together on our common goal of greater patient safety."
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MHRA recalls all pholcodine-containing medicines from UK - 0 views

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    The Medicine and Healthcare Product Regulatory Agency (MHRA) has recalled all pholcodine-containing medicines from the UK pharmacy due to concerns of its potential to cause a severe allergic reaction in some people having general anaesthesia for surgery. The decision was made following the conclusion of a review of post-marketing safety data by the MHRA. The Commission on Human Medicines (CHM) has considered the evidence of an increased risk of the very rare event of anaphylaxis when exposed to neuromuscular blocking agents (NMBA) and advised that pholcodine-containing medicines should be withdrawn. MHRA has advised pharmacists to consider recommending appropriate treatment alternatives for patients who present with a new dry cough or who are currently taking pholcodine. Royal Pharmaceutical Society (RPS) President Professor Claire Anderson said: "If you are taking a cough medicine (including tablets and syrups), check the packaging, label or Patient Information Leaflet to see if pholcodine is a listed ingredient - if it is, and you have any questions, you can talk to your pharmacist who can suggest a different medicine suitable for you.
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MHRA Alert on Semaglutide Risks : Safeguard Your Health: - 0 views

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    The Medicines and Healthcare Products Regulatory Agency (MHRA) confirmed that Ozempic has been found at two UK wholesalers on 18 October. The pre-filled falsely labelled pens have been purchased from legitimate suppliers in Austria and Germany. However, there has been no evidence that fake Ozempic has been supplied to UK patients. Dr Alison Cave, MHRA Chief Safety Officer spoke about closely with regulatory partners to ensure patients' safety. He said: "Buying semaglutide from illegally trading online suppliers significantly increases the risk of getting a product either falsified or not licensed for use in the UK. "Products purchased in this way will not meet our strict quality and safety standards, and taking such medicines may put your health at risk," he added.
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Valproate Alert: Men's Fertility Risks Revealed - MHRA Caution - 0 views

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    The Medicine and Healthcare products Regulatory Agency (MHRA) has cautioned men on valproate to talk to their healthcare professional about their treatment, if they want to start a family in the next year. The warning came after a new study, commissioned by the European Medicines Agency, suggested that children fathered by men who took the anti-seizure medicine in the three months prior to conception may be at higher risk of developing neurodevelopmental disorders. Around five in 100 children born to fathers treated with valproate around conception were diagnosed with a neurodevelopmental disorder, compared to three in 100 children whose fathers were taking other antiseizure medicines (lamotrigine or levetiracetam). However, the risk is believed to be much smaller than the risk associated with valproate in pregnancy.
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Cozaar 100mg Tablets Safety Alert - MHRA Notice - 0 views

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    The Medicines and Health products Regulatory Agency (MHRA) on Thursday issued a class 4 medicines defect information notice for Cozaar 100mg film-coated tablets due to an error in the Patient Information Leaflets (PILs) reported by the company. Cozaar is used to treat high blood pressure (hypertension) as well as to slow the progression of kidney disease in people who have type 2 diabetes mellitus. Quadrant Pharmaceuticals Ltd has informed the UK regulatory authority that the PILs that have been packed in certain batches of the products do not have the most up to date safety information. 'Grapefruit juice should be avoided while taking Cozaar'- This information is missing in Section 2 'What you need to know before you take Cozaar', sub section 'Cozaar with food and drink', the company clarified.
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MHRA Class 3 Recall: Sildenafil 100mg Tablets - 0 views

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    The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 3 medicines recall for Sildenafil 100mg Film-coated Tablets (Strandhaven Limited T/A Somex Pharma). Manufacturer of drug, Strandhaven Limited T/A Somex Pharma has informed the MHRA that the pack size on some cartons of the batch state 8 tablets instead of 4 tablets. This is an error due to cartons being mixed at the printers. All cartons with batch number ET22028 contain one blister strip of 4 tablets regardless of whether it states 8 tablets or 4 tablets on the pack. Only the batch number ET22028 is affected. Due to the low number of complaints received, only the packs labelled as containing 8 tablets are being recalled at this time. The batch is comprised of 60340 packs, to date 195 packs have been found to be mislabelled.
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Roche AccuChek Insulin pumps: warning over insulin leakage - 0 views

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    Following concerns raised about cracked cartridges and insulin leaks, the Medicines and Healthcare products Regulatory Agency (MHRA) has issued a national patient safety alert for the NovoRapid PumpCart prefilled insulin cartridge and the Roche Accu-Chek Insight Insulin pump system. The regulator have asked patients to check the pre-filled glass insulin cartridge for cracks before use. It advised against using the cartridge if it has been dropped even if no cracks are visible and urged to closely follow the updated handling instructions in the pump user manual when changing pre-filled glass insulin cartridges. In some of the reported leakage incidents, the cartridges were found to be cracked and provided an inadequate supply of insulin to patients. Leakages also occurred in cases where no cracks in the cartridge were visible, the regulator said. In some patients there were consequences of not receiving enough insulin from their pump system, including reports of severely high blood sugar and diabetic ketoacidosis, a serious complication of diabetes when the body produces high levels of blood acids called ketones. Healthcare professionals are being advised to contact patients over the next six months using said device to discuss their individual needs and source an alternative pump where appropriate. "Because of the rare risk of insulin leakage from the Roche Accu-Chek Insight Insulin Pump, patients should check the pre-filled glass insulin cartridge for any cracks prior to usage," Dr June Raine, MHRA chief executive, said.
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Stay Informed: Aripiprazole Side Effects & Gambling Risks - 0 views

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    The Medicines and Healthcare products Regulatory Agency (MHRA) has reminded healthcare professionals prescribing aripiprazole to alert patients about its possible side effects, following a rise in the number of reports of gambling disorder associated with the drug. Patients taking aripiprazole, which is used for the treatment of schizophrenia and bipolar disorder, are at risk of developing unusual urges or cravings that they cannot resist, including behaviours such as addictive gambling, excessive eating or spending, or an abnormally high sex drive. The regulator has received 69 reports of gambling or gambling disorder suspected to be caused by aripiprazole in the last 14 years via the Yellow Card Scheme, out of which 32 were received between 1 January and 31 August this year. Alison Cave, MHRA Chief Safety Officer, said: "The number of reports for suspected gambling and other impulsive behaviours associated with aripiprazole are small in comparison to the frequency with which it is prescribed, but the consequences for any patient developing these conditions can be significant."
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MHRA Warning: Beware Counterfeit Anti-Choking Devices - 0 views

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    The Medicines and Healthcare products Regulatory Agency (MHRA) has advised the public to exercise caution when buying anti-choking devices online, ensuring these products are purchased from reputable sellers. As estimated by the regulator, more than 10,000 counterfeit or unbranded anti-choking devices have been purchased by the public within the last two years through listings on online marketplaces such as Amazon and eBay, as well as drop-shipping websites. People are cautioned that the use of such products poses a substantial risk of failure in clearing blockages and could exacerbate the situation by pushing obstructions further down into the airway passage. Dr Alison Cave, MHRA Chief Safety Officer, said: "Buying anti-choking devices that do not have a valid UKCA or CE mark increases the risk of receiving a product which does not include appropriate instructions and is either fake or does not meet the UK's regulatory requirements. "These products do not meet our strict quality standards and may put your health and safety at significant risk by failing to resolve or even worsening choking incidents."
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