Group items tagged

AstraZeneca UK has revised the expiry dates for certain batches of Fluenz Tetra nasal spray vaccines as a precautionary measure, after finding that their potency (strength) dropped faster than predicted once thawed, during routine testing. The Medicines and Healthcare products Regulatory Agency (MHRA) has been informed by the manufacturer that the printed expiry date for a limited number of batches is "incorrect." However, the MHRA has assured patients that the affected batches are safe to use and fully effective within the amended expiry date. If the vaccine is administered after the amended expiry date, it may be less effective in protecting against flu, it said. The UK regulatory authority also reiterated that it "keeps the safety of medicines, including vaccines, under review, and acts where necessary to protect patients and the public."

The Criminal Enforcement Unit (CEU) of the Medicines and Healthcare products Regulatory Agency (MHRA) seized a large quantity of suspected illegally traded medicines, including powerful prescription-only medicines, during raids conducted at two residential and two business premises across North Manchester. Officers from the MHRA and Greater Manchester Police carried out searches across two residential addresses in Oldham and Cheetham in the early hours of Wednesday (29 November), and arrested a man in his 20s on "suspicion of conspiracy to supply controlled drugs, breaches of the Human Medicines Regulations 2012 and money laundering." They also seized thousands of illegal medicines from two business addresses in Bury and Miles Platting, including powerful opioid painkillers and antidepressants, as well as unlicensed versions of erectile dysfunction drugs.

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.

The Department of Health and Social Care (DHSC) has introduced a new prescription pre-payment certificate (PPC) for Hormone Replacement Therapy (HRT) which is said to benefit around 400,000 women who suffer from negative symptoms of the menopause in England. PPC will be rolled-out from 1 April and it reduce the HRT costs to less than £20 a year. Women prescribed HRT - the main treatment for menopause symptoms - will have access to a new scheme enabling access to a year's worth of menopause prescription items for the cost of two single prescription charges (currently £18.70). As part of commitments to reduce the cost of HRT for menopausal women, the prescription PPC will be valid for 12 months. It can be used against a list of HRT prescription items, and a patient can use this against an unlimited number of HRT items, such as patches, tablets and topical preparations. There will be no limit to how many times the certificate can be used while it is valid. "The introduction of the certificate delivers one of our year one priorities for the Women's Health Strategy for England. Published last summer, the strategy sets out an ambitious new agenda for improving the health and wellbeing of women and girls and to improve how the health and care system listens to women. Menopause was announced as a priority area within the strategy," said DHSC.

The Medicines and Healthcare products Regulatory Agency (MHRA) on Monday (29 January 2024) approved the medicine Rezzayo (rezafungin) to treat invasive candidiasis, an infection caused by a yeast called Candida. Invasive candidiasis can pose a serious health risk as it can affect the blood, heart, brain, eyes, bones and other parts of the body. Napp Pharmaceuticals Ltd was granted the marketing authorisation for the medicine based on phase 3 clinical trial data. In the randomised, double-blind, controlled study, more than half of the invasive candidiasis patients who were given a weekly dose of rezafungin were cured at day 14. Among 94 patients who were given a daily dose of caspofungin (another antifungal treatment), 57 of them were cured during the same time.

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.