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Spotlight

Every month, the subjects in Prescrire’s Spotlight.

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100 most recent
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Environmental impact of drugs: taking drug utilisation data into account

Outlook Drug residues have been detected in surface water and groundwater in countries around the world. The main source of residues of drugs for human use in the environment is excretion in the urine and faeces. A team of Swedish and Italian researchers has developed a tool for predicting the environmental impact of drugs that takes drug utilisation data into account.
Full article available for download by subscribers (3 pages)

1 October 2024

European "pharmaceutical package": letter on clinical data exclusivity

Advancing Healthcare Policy Prescrire was a cosignatory of a letter sent to members of the European Parliament asking them not to extend the regulatory protection afforded to originator medicinal products.
Full article available for download (free)

1 October 2024

Short-term interruption of treatment with a xaban or dabigatran: sometimes fatal thrombosis

Adverse Effects A study based on a South Korean health insurance database, including 11 000 patients with atrial fibrillation who were treated with a xaban-type oral anticoagulant or dabigatran and followed up for one year, showed that treatment interruption, even for one day, was associated with a 2-fold increase in the risk of premature death and a 10-fold increase in the risk of stroke, transient ischaemic attack or systemic embolism.
Full article available for download by subscribers

1 October 2024

Phasing out patient leaflets in paper form: eco-responsible or irresponsible?

Editorial In 2023, the European Commission embarked on a thorough revision of Europe's pharmaceutical legislation. One of the proposed changes is to gradually phase out package leaflets in paper format and replace them with an electronic version.
Full article available for download (free)

1 September 2024

Selinexor (Nexpovio°) in relapsed or refractory multiple myeloma: not acceptable

Marketing Authorisations For patients with relapsed or refractory multiple myeloma, various combinations of antineoplastic drugs extend survival. Selinexor, an exportin-1 inhibitor, has been authorised in the European Union for use in multiple myeloma: in combination with bortezomib and dexamethasone after at least one line of treatment; and in combination with dexamethasone after at least four lines of treatment.
Full article available for download by subscribers (3 pages)

1 September 2024

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

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