-
Please provide any post marketing and yellow card scheme reports linking Mirabegron and LBBB(left branch bundle block)
Published: 31 December 2025
-
I am Yellow card champion at UHDB, which falls within the West Midlands Yellow card centre for reporting data. I receive comparison data for other organisations within the West Midlands, but we would also be interested to see this data for the East Midlands. The larger of the two acute hospitals which makes up our Trust is Derby, which sits in East Mids area for many aspects of clinical care / local health economy pathways hence our interest in EM data.
Published: 31 December 2025
-
MHRA NI_PASSS inspection conducted or reported in 2023 (after August 2023), 2024 and 2025 Please may i request the above inspection reports under fOI.
Published: 31 December 2025
-
I request copies of notifications for the import into the UK of datopotamab deruxtecan from December 2024 onwards. Such notifications would be required under the so-called specials regime.
Published: 31 December 2025
-
Please could you provide the currently approved .pdf artwork mock-ups of the patient leaflet, outer label/carton and inner label for the product PERFALGAN 10 mg/ml, solution for infusion, under licence number PL 12038/0006? I have attached the current SmPC to confirm the licence details.
Published: 31 December 2025
-
I am trying to find data on all yellow card reports associated with three uk weight loss drugs and cannot find anything on the yellow card site. I have seen studies in online journals etc but would like to see a list of all associated side effects with a quantity against it for Mounjaro, Wegovy and Saxenda. All side effects including death data, whether death directly because of it or following on from other side effects please.
Published: 31 December 2025
-
We would like to formally request the following information regarding the medical device ConvaNiox: • Conformity assessment conducted by UK Approved Bodies, followed by registration with the MHRA. • Supporting documentation submitted as part of the application for CE marking.
Published: 31 December 2025
-
I am writing to request information regarding reported adverse events associated with the following medicinal products: Amgevita, Humira and Imraldi. Specifically seeking clarity on whether the MHRA has received any reports of alopecia (hair loss) linked to the use of these products. Would it be possible to provide the following details: - The number of reports received for each medicine - The nature and severity of the cases - any other additional information. Please note I have reviewed the Yellow Card drug analysis profiles and there is only data available for the active ingredient (ADALIMUMAB) and no information for the individual products as mentioned above.
Published: 31 December 2025
-
Freedom of Information request - British Pharmacopoeia Commission (BPC) Minutes A meeting of the British Pharmacopoeia Commission was held at 10 South Colonnade, Canary Wharf, London E14 4PU on Monday 1st July 2024 Minute 670 – Bacterial Endotoxin Update - states in full "The Secretariat had discussed the request for revision for high endotoxin limits with representatives from the Ph. Eur. BET expert group and Group 12 and had been invited to present on the issue at a future meeting of CHMs Chemistry, Pharmacy and Standards committee. A member raised a query from a user about the European Pharmacopoeia method 2.6.14 on endotoxin testing, noting that the endotoxin tolerance standard be harmonised across these product types. The request, along with input from representatives of the Ph. Eur. BET expert group and Group 12, as well as confirmation of the approach taken by MHRA assessors would be discussed further at a future BPC meeting." My requests refer to the highlighted text in the order reported. Please provide the following 1. Details of the request for revision for high endotoxin limits, including - a list of product type affected - the current baseline and proposed increased limits taken to be parenteral and intrathecal/epidural - if this is discussed in future meeting a copy of the minutes showing the discussion - the justification for increasing the limits 2. A copy of the European Pharmacopoeia method 2.6.14 3. A list of what were considered to be unharmonized endotoxin standards and the product types across which they are not harmonised as per request 1 4. Details of the approach taken by MHRA assessors to high endotoxin or a link to source showing justification for the MHRA approach 5. Minutes of the meeting in which the matters were discussed and any report following, NB the website stops publishing 3 March 2025 and there is no record of this discussion My justification for these disclosures is based on well-founded concerns for public health. There is an overriding public interest for disclosure of plans for raising the acceptable level of endotoxin in pharmaceutical products in view of events of the past 5 years Endotoxin is classified as a pyrogen which is supposed to be present unintentionally “Pyrogens are fever-inducing contaminants that may unintentionally be present in medicines administered by injection (including vaccines, blood products, radiopharmaceuticals, antibiotics and large volume solutions for infusion)”. It is also however an excipient. IN other words, it is deliberately introduced to the very same products that we have been told the MHRA is working so hard to make contaminant free. Endotoxin in particular was used in the production of the coronavirus vaccine as noted in the patent filed by Ugur Sahin, “Coronavirus vaccine” Saccharolipids describe compounds in which fatty acids are linked directly to a sugar backbone, forming structures that are compatible with membrane bilayers. In the saccharolipids, a monosaccharide substitutes for the glycerol backbone present in glycerolipids and glycerophospholipids. The most familiar saccharolipids are the acylated glucosamine precursors of the Lipid A component of the lipopolysaccharides in Gram-negative bacteria. Typical lipid A molecules are disaccharides of glucosamine, which are derivatized with as many as seven fatty-acyl chains. The minimal lipopolysaccharide required for growth in E. coli is Kdo2-Lipid A, a hexa-acylated disaccharide of glucosamine that is glycosylated with two 3-deoxy-D-manno-octulosonic acid (Kdo) residues.” A search on the National Library of Medicine using the terms “organ distribution endotoxin “ brings up 551 results. This a well-studied and understood subject, and of great relevance in view of the pharmacokinetic nature of chemically purified lipopolysaccharide LPS This differs significantly from natural bacterial endotoxin both in biodistribution and effect. This too is well known to the scientific and pharmaceutical industry as reported in this paper from 1994 “Cellular distribution of endotoxin after injection of chemically purified lipopolysaccharide differs from that after injection of live bacteria” Antigenic LPS was detected in all tissues 1 hour after injection of both bacteria and LPS and was present in liver and spleen over the 28-day study period. Whole bacteria were identified in tissue macrophages for the first 48 h after injection; later, bacterial cell walls were replaced by diffuse antigenic material throughout the cytoplasm Antigenic LPS was localized within hepatocytes only after injection of chemically purified LPS. Engineered LPS goes to the liver and remains there for 28 days. This is consistent with the patent for coronavirus mentioned above regarding Lipid A which uses lipid A as an immunostimulant with a preference to target the liver, The same “Coronavirus Vaccine” patent asserts that “Immunostimulants may be provided to a subject by administering to the subject RNA encoding an immunostimulant in a formulation for preferential delivery of RNA to liver or liver tissue. The delivery of RNA to such target organ or tissue is preferred, in particular, if it is desired to express large amounts of the immunostimulant and/or if systemic presence of the immunostimulant, in particular in significant amounts, is desired or required. RNA delivery systems have an inherent preference to the liver. This pertains to lipid-based particles, cationic and neutral nanoparticles, in particular lipid nanoparticles such as liposomes, nanomicelles and lipophilic ligands in bioconjugates. Liver accumulation is caused by the discontinuous nature of the hepatic vasculature or the lipid metabolism (liposomes and lipid or cholesterol conjugates).” NHS digital publishes hospital finished consultant data using ICD Codes. Both liver disease and thyroid dysfunction are on the increase with obvious spikes or trends correlating to the vaccine rollout. Some of these 8000+ charts translated from excel to Python are in Appendix 1 The same patent describes how the product works through draining lymph nodes “The “lymphatic system” is part of the circulatory system and an important part of the immune system, comprising a network of lymphatic vessels that carry lymph. The lymphatic system consists of lymphatic organs, a conducting network of lymphatic vessels, and the circulating lymph. The primary or central lymphoid organs generate lymphocytes from immature progenitor cells. The thymus and the bone marrow constitute the primary lymphoid organs. Secondary or peripheral lymphoid organs, which include lymph nodes and the spleen, maintain mature naïve lymphocytes and initiate an adaptive immune response. RNA may be delivered to spleen by so-called lipoplex formulations, in which the RNA is bound to liposomes comprising a cationic lipid and optionally an additional or helper lipid to form injectable nanoparticle formulations. “ Endotoxin is one of the contaminants which the lymphatic system is uniquely designed to degrade and remove and immune system pushes it there from which should be degraded and expelled Lymph invasion route of bacteria and endotoxin and CD4+/CD8+ T cells ratio changes of draining lymph node of burn infection wound “Lymph fluid in the efferent lymph trunk of CILN was collected for the measurement of endotoxin by the Limulus Amebocyte Lysate test. Lymph fluid tumor necrosis factor-alpha (TNF-α) concentration was measured by enzyme-linked immunosorbent assay (ELISA).” The MHRA has published a paper entitled “Impact of COVID-19 vaccine reports on disproportionality analyses for other vaccines” , in which necrotic lymphadenopathy is an overriding signal from Pfizer product Evidence mentioned above shows that commercial endotoxin behaves differently to endotoxin from natural bacteria and is not easily cleared form the body which plausibly explains the severe lymphadenopathy . While correlation is not causation there is strong correlative evidence in NHS diagnostic data suggesting the level of endotoxin agreed in the coronavirus vaccine contract at 12.5 EU/ml for product and 12.5 EU/ml for substance was very high and dangerously so and exceeded safe limits. All examples in Appendix 1 reflect endotoxin substance biodistribution It is therefore in the overriding public interest to know what future plans are for normalising a new high level of endotoxin to ensure product safety is maintained and public trust in regulators can be maintained.
Published: 31 December 2025
-
Alison Cave recently stated that there had been a multitude of studies globally which have proved that vaccines do not cause autism. Can you please provide me with a list of the studies she relied upon to make that statement?
Published: 31 December 2025
