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Spotlight

Every month, the subjects in Prescrire’s Spotlight.

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100 most recent
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Bupropion + naltrexone (Mysimba°) for weight loss: set to be withdrawn from the market in the European Union?

Marketing Authorisations The pharmaceutical company Orexigen Therapeutics has failed to fulfil its obligation to conduct a post-authorisation trial to assess the long-term cardiovascular adverse effects of the fixed-dose combination of bupropion + naltrexone (Mysimba°), which is authorised in the European Union for use in patients with obesity or who are overweight. Now, 9 years after its authorisation, the European Commission has asked the European Medicines Agency to review its harm-benefit balance.
Full article available for download by subscribers

1 September 2024

In-utero exposure to corticosteroids: increased risk of serious infections during the first year of life

Adverse Effects A study using Taiwanese healthcare databases, including about 2 million children, assessed the risk of infection linked to in-utero exposure to a corticosteroid prescribed to prevent prematurity-related respiratory distress syndrome. The risk of hospitalisation for a serious infection during the first year of life appeared to be about 25% greater in the exposed children.
Full article available for download by subscribers

1 September 2024

Prescrire's review of drug packaging in 2023: reconciling ease of use with safety is an ongoing challenge

Drug packaging can be considered high quality if it makes the drug safer and easy to use, and if it is designed to protect people who come into contact with the patient from the risk of poisoning, especially children.
Full article (4 pages) available for download (free)

1 September 2024

Prescrire's contribution to the EMA's consultation on the "Concept Paper for the Development of a Guideline on Non-Inferiority and Equivalence Comparisons in Clinical Trials"

Advancing Healthcare Policy In the interests of patients, Prescrire's contribution emphasises two points that are fundamental to the quality and safety of health care, and that the EMA must take into account while developing its forthcoming guideline on "non-inferiority" trials.
Full article available for download (free)

1 September 2024

European Commission: lobbyists block nutritional labelling

Editorial Nutri-Score is a labelling system for food and beverages that informs consumers about the product's nutritional quality. The label is displayed on food packaging on a voluntary basis by manufacturers, and by supermarket chains on their own-brand products.
Full article available for download (free)

1 July 2024

Dupilumab (Dupixent°) in prurigo nodularis

Marketing Authorisations Dupilumab, an immunosuppressive monoclonal antibody directed against interleukin-4 and interleukin-13 receptors, has been authorised in the European Union for the treatment of prurigo nodularis, a condition that can greatly impair patients' quality of life.
Full article available for download by subscribers

1 July 2024

Netarsudil (Rhokiinsa°) or netarsudil + latanoprost (Roclanda°) in chronic glaucoma: not acceptable

Marketing Authorisations Eye drops containing netarsudil, alone or combined with latanoprost, have been authorised in the European Union to lower intraocular pressure in adults with chronic open-angle glaucoma or ocular hypertension. Netarsudil exposes patients to a higher risk of adverse effects than the first-choice ocular antihypertensive drugs, timolol or latanoprost, while offering no demonstrated gain in efficacy.
Full article available for download by subscribers

1 July 2024

Zanubrutinib (Brukinsa°) in certain haematological malignancies

Marketing Authorisations Zanubrutinib has been authorised for use in chronic lymphocytic leukaemia and Waldenström macroglobulinaemia (as has ibrutinib), and in certain patients with relapsed or refractory marginal zone lymphoma. Does zanubrutinib extend survival compared with the other options used in these situations, in particular ibrutinib? Does it have fewer or less severe adverse effects than ibrutinib?
Full article available for download by subscribers

1 July 2024

Methadone: an analysis of adverse effects reported in France

Adverse Effects Methadone, a long-acting opioid, is used for the treatment of opioid dependence and as an analgesic. A French regional pharmacovigilance centre analysed, over a 10-year period, 509 reports of adverse effects in patients exposed to methadone, of which 8 out of 10 were serious. By being aware of the situations in which the use of methadone carries a risk of serious adverse effects, these situations can be anticipated.
Full article available for download by subscribers

1 July 2024

Mediator° trial appeal: a judgement that better reflects the harm done

Outlook French appeal court finds Servier guilty of four charges, handing down sentences more respectful of the victims of decades of constant, organised deception.
Full article available for download (free)

1 July 2024

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