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Spotlight

Every month, the subjects in Prescrire’s Spotlight.

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Spotlight

100 most recent
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DSM: still riddled with conflicts of interests

Editorial The American Psychiatric Association (APA) has been producing successive versions of the Diagnostic and Statistical Manual of Mental Disorders (DSM) since 1952. The aim of the DSM is to propose a definition for every psychiatric disorder.
Full article available for download (free)

1 October 2024

Finerenone (Kerendia°) in chronic kidney disease with albuminuria associated with type 2 diabetes

Marketing Authorisations Patients with type 2 diabetes are at risk of microvascular disease, which can lead to kidney failure. The aldosterone receptor antagonist finerenone has been authorised in the European Union for use in patients with type 2 diabetes who have developed chronic kidney disease with albuminuria. Does finerenone reduce mortality or the incidence of end-stage kidney disease in this situation? And what are its adverse effects?
Full article available for download by subscribers (4 pages)

1 October 2024

Solifenacin + tamsulosin (Vecalmys°/Vesomni°) in benign prostatic hyperplasia: not acceptable

Marketing Authorisations A fixed-dose combination of the antimuscarinic drug solifenacin and the alpha-1 blocker tamsulosin has been authorised in France and some other European countries to relieve the symptoms of benign prostatic hyperplasia when monotherapy (of any kind) has been considered insufficiently effective.
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1 October 2024

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.
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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.
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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

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