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The Medicines and Healthcare products Regulatory Agency (MHRA) has asked the pharmacies and wholesalers to stop supplying and quarantine all remaining stock of Dr Reddy's Laboratories (UK)'s Lacidipine 4 mg Film-Coated tablets. The company has recalled two batches of Lacidipine 4 mg Film-Coated tablets as a precautionary measure due to the presence of an unknown solvent-like odour. MHRA said: "The tablets are normally odourless. However, in the affected batches, a solvent-like odour is present when the individual blisters are opened. Additionally, some patient complaints have noted that the tablets have an unusual taste. The investigation to determine the root cause and to identify and quantify the odour is ongoing. "The issue is confined to batches B2202043 and B2202044 only. Other batches of Lacidipine 4 mg Film-Coated tablets marketed by Dr Reddy's Laboratories (UK) are not affected."

The Medicines and Healthcare products Regulatory Agency (MHRA) has appointed Dekra to certify medical devices in the UK. Dekra Certification UK has joined the three current UK approved bodies, increasing the UK's capacity to process conformity assessments for medical devices to ensure safe and effective devices reach the UK public. An approved body is an organisation that has been designated by the MHRA to assess whether manufacturers and their medical devices meet the requirements set out in  the UK Medical Devices Regulations 2002. Following an appropriate assessment, the new approved body will issue relevant certification allowing manufacturers to place a UKCA marking on their products before putting them on the market. Dr Laura Squire, chief healthcare quality and access officer at the MHRA, said: "This is a major milestone in our mission to ensure patients across the UK have access to the high-quality medical devices they need to protect their health.

Colonis, a subsidiary company of the Clinigen Group has received the Medicines and Healthcare products Regulatory Agency (MHRA) approval for Melatonin 1mg/ml Oral Solution for sleep onset insomnia in children and adolescents aged 6-17 years with attention-deficit hyperactivity disorder (ADHD). Clinical evidence demonstrates that Melatonin has the potential to decrease sleep latency and increase sleep efficiency in children with ADHD and chronic sleep onset insomnia. Children with ADHD are statistically more likely to have sleep onset insomnia than non-ADHD children. The prevalence of sleep onset insomnia in children with ADHD ranges from 25%-50%. Sleep onset insomnia in children with ADHD can affect their mood, attention, behaviour and school performance. Henno Welgemoed, Director of Medical Affairs at Colonis said: "We welcome the MHRA's approval for a condition that negatively affects the quality of life for children and adolescents diagnosed with ADHD and increases the burden for support networks."

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched new guidance to highlight the latest safety advice on the steps to take during anaphylaxis. On the start of World Allergy Week (19 June), an annual initiative led by the World Allergy Organization, aiming to raise awareness of allergies, their management and prevention, the MHRA has collaborated with allergy awareness advocates to share an easy step-by-step infographic guide and video outlining the latest advice from the CHM's working group on the safe and effective use of AAIs. Steve Barclay, Secretary of State for Health and Social Care said: "A severe allergic reaction can be life-threatening. One in five people in the UK suffer with at least one allergy, so it's vital people are equipped with the knowledge to keep themselves safe. Adrenaline auto-injectors - also known as AAIs or by their brand names such as EpiPen - are highly effective and convenient for the immediate treatment of anaphylaxis. If you have been prescribed one, please carry it with you at all times and make sure you are up to date on the latest safety guidance - it could save your life."

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a second "bivalent" vaccine as a Covid-19 booster. The updated booster vaccine made by Pfizer/BioNTech, targeting two coronavirus variants, has been approved for use in individuals aged 12 years and above. In each dose of the booster vaccine, 'Comirnaty bivalent Original/Omicron', half of the vaccine (15 micrograms) targets the original virus strain and the other half (15 micrograms) targets Omicron (BA.1). Dr June Raine, MHRA chief executive said: "I am pleased to announce that we now have a second approved vaccine for the UK Autumn booster programme. The clinical trial of the Pfizer/BioNTech bivalent vaccine showed a strong immune response against the Omicron BA.1 variant as well as the original strain. Bivalent vaccines are helping us to meet the challenge of an ever-evolving virus, to help protect people against Covid-19 variants. We have in place a comprehensive safety surveillance strategy for all UK-approved Covid-19 vaccines, and this will include the updated booster we approved today."

The Medicines and Healthcare products Regulatory Agency (MHRA) has warned the public to avoid buying pre-filled weight loss pens without a prescription. The warning came after 369 fake Ozempic injections have been seized since January 2023. However, Saxenda pens were obtained by members of the public in the UK through "non-legitimate routes". The health regulator has urged the public to buy the pens after consulting a healthcare professional and with a prescription. Dr Alison Cave, MHRA Chief Safety Officer shared her opinion on the matter, she said: "Buying products such as Ozempic or Saxenda without a prescription, from illegally trading suppliers, significantly increases the risk of receiving something which is either fake or not licensed for use in the UK.

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."

In what's seen as a major step forward for the treatment of schizophrenia, the Medicines and Healthcare Products Regulatory Agency (MHRA) has authorised a new Johnson & Johnson drug in Britain. Byannli is a six-monthly paliperidone palmitate (PP6M) and is the first long-acting injectable schizophrenia treatment which offers patients the potential for up to six months of symptom control and a reduction in their risk of relapse with only two doses a year. It is a long-acting injectable that works by dissolving and entering the bloodstream slowly, due to its extremely low water solubility, resulting in continuous absorption of paliperidone palmitate over a six-month period. "Schizophrenia is a chronic and severe brain disorder, and antipsychotic medication plays an important role in its treatment. However, many people with the illness experience relapses which are often caused by poor adherence to oral medication," said Prof David Taylor, director of Pharmacy and Pathology at the Maudsley Hospital.

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.

Thousands of lung cancer patients in England will benefit from a ground-breaking new drug that can reduce the risk of relapse. This follows a deal brokered by NHS England and approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for atezolizumab therapy to treat non-small cell lung cancer (NSCLC). More than 850 patients are expected to be eligible for the drug in the first year, rising to more than 1000 in the third year. It is the first immunotherapy approved for patients with early-stage NSCLC who have undergone surgery and chemotherapy. Clinical trials have shown that atezolizumab can reduce the risk of cancer relapse or death by 34 per cent in patients with early-stage NSCLC.

The General Pharmaceutical Council reiterated its stand on Covid-19 vaccination, saying, "Pharmacists and pharmacy technicians working in all settings across Great Britain should be vaccinated against Covid -19, unless they are medically exempt." In a statement issued today (February 11), it strongly urged all pharmacyprofessionals, students and trainees to get fully vaccinated at the earliest. This reiteration follows the government's announcement on January 31, 2022 that it would not proceed with Covid vaccination as a mandatory condition of deployment for health and care staff providing CQC-regulated services in England. The Council stated that clinical trials have proven the efficacy and safety of Covid vaccines and the Medicines and Healthcare products Regulatory Agency (MHRA) has authorised their use in the UK.

The Medicines and Healthcare products Regulatory Agency (MHRA) on Wednesday (9 January) announced that the novel type 2 oral polio vaccine (nOPV2) has been quality-assured (prequalified) by the World Health Organization (WHO). Developed by a team including scientists from the MHRA, nOPV2 is considered a safer polio vaccine that helps to protect children from the disabling and life-threatening disease and lower the risk of vaccine-derived outbreaks. The vaccine received WHO Emergency Use Listing three years ago, and since then 950 million doses have been delivered worldwide. The UN health agency's decision to add it to the list of prequalified vaccines is based on the analysis of outcomes in vaccinated populations that has confirmed strong safety profile and effectiveness.

In a significant leap forward in the fight against HIV, the Medicines and Healthcare products Regulatory Agency (MHRA) has given the green light to two groundbreaking formulations of cabotegravir. Apretude 30 mg film-coated tablets and Apretude 600 mg prolonged-release suspension for injection are now authorized for preventing sexually transmitted HIV-1 infection in adults and adolescents weighing at least 35kg at increased risk. This approval marks a pivotal moment in HIV (human immunodeficiency virus) prevention, offering an alternative to existing standard pre-exposure prophylaxis or PrEP treatments. HIV, a virus notorious for compromising the immune system, has long been a global health concern. Cabotegravir, a member of the integrase inhibitor group, works by blocking a key enzyme necessary for the replication of HIV-1, thereby reducing the virus's ability to spread.

American pharmaceutical giant Pfizer has received marketing authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) for its medication Etrasimod, marketed as Velsipity, used to treat people with moderately to severely active ulcerative colitis. Ulcerative colitis (UC) is a type of inflammatory bowel disease (IBD) that causes inflammation and ulcers (sores) in the lining of the large intestine (colon) and rectum. The approved recommended dose for Velsipity is one 2 mg tablet to be taken once daily. For the first three days, it is advised to take the medication with food, and subsequently, it can be taken daily either with or without food. According to the regulator, the approval of the medication is based on evidence from two clinical studies, which showed that 26 per cent of patients taking etrasimod achieved clinical remission after 12 weeks of treatment compared with 11 per cent of those receiving placebo. The studies included more than 740 patients aged 16 years and over for whom standard treatment or other treatments did not work well enough or could not be used.

Britain's drug regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) on Monday announced that fluoroquinolone antibiotics must only be administered when no other antibiotics are appropriate for use. It elaborated that fluoroquinolones given systemically (by mouth, injection, or inhalation) should only be prescribed "when other recommended antibiotics have failed, will not work due to resistance, or are unsafe to use in an individual patient." Previous regulations on fluoroquinolones stated that this class of antibiotics should not be prescribed for mild to moderate or self-limiting infections, or non-bacterial conditions. Further restrictions have been introduced after receiving reports from patients who have experienced long-lasting or disabling reactions following use of fluoroquinolones, the MHRA revealed. Dr Alison Cave, MHRA Chief Safety Officer, said: "Patient safety is our top priority. We have listened to the experience of patients regarding long-lasting and potentially irreversible adverse reactions following use of fluoroquinolone antibiotics, in some cases prescribed for mild-to-moderate infections.

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new indication of semaglutide (Wegovy), authorising its use to reduce the risk of serious heart problems and strokes in adults who are obese or overweight. Semaglutide, a GLP-1 receptor agonist, was previously approved for use in the treatment of obesity and weight management, to be used alongside diet, physical activity and behavioural support. The latest approval establishes it as the first weight loss drug to be prescribed to prevent cardiovascular events, such as cardiovascular death, non-fatal heart attack and non-fatal stroke, in people with established cardiovascular disease and a Body Mass Index (BMI) higher or equal to 27 kg/m2. Novo Nordisk, the manufacturer of Wegovy, received this authorisation on 23 July following compelling evidence from a recent post-approval clinical study involving over 17,600 participants. The study demonstrated that Wegovy, administered at a dose of 2.4 mg once weekly via subcutaneous injection for up to five years, significantly lowers the incidence of major adverse cardiovascular events (MACE) by 20 per cent compared to a placebo.

Great news for multiple sclerosis patients! The NHS has introduced a new 10-minute injection that can slow the progression of disability while reducing hospital treatment time by over 90 per cent. Currently, MS patients in England receive ocrelizumab (Ocrevus), manufactured by Roche, through twice-yearly intravenous (IV) infusions that can last up to four hours. Now, around 9,000 NHS patients in England will be able to receive the drug via a quick 'under-the-skin' twice-yearly injection. It takes just ten minutes, enabling patients to spend less time in the hospital receiving treatment. This roll-out follows approval from the Medicines and Healthcare products Regulatory Agency (MHRA), making the NHS one of the first healthcare systems worldwide to offer this new MS injection. Drug stocks are expected to be available in the coming weeks.