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Spotlight

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100 most recent
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GLP-1 agonists: depression, suicidal thoughts or behaviour?

Adverse effects In July 2023, the European pharmacovigilance committee (PRAC) decided to launch a review of GLP-1 agonists, following reports of suicidal thoughts and thoughts of self-harm. To what extent do GLP-1 agonists expose patients to a risk of depression, suicidal ideation, attempted suicide or suicide? This article summarises the main findings of our search of the literature for answers to this question.
Full article available for download by subscribers

1 April 2024

Is Prescrire overly alarmist about conditional marketing authorisations?

Outlook Following the publication (in Prescrire International n° 246) of an Editors’ Opinion on the withdrawal of the conditional marketing authorisation for rucaparib (Rubraca°) in certain types of ovarian cancer, we received a letter from a senior official at the European Medicines Agency (EMA). This letter provides us with the opportunity to review the issues and risks associated with “conditional” marketing authorisations.
(see also "Winners and losers" Prescrire Int n° 246, subscribers only)
Full article available for download by subscribers

1 April 2024

First version of the European list of critical medicines: Prescrire's comments

Outlook A lack of transparency that the authors could swiftly rectify to allay concerns over how the list was compiled and why certain medicines are missing.
Full article available for download (free)

1 April 2024

40 years without sales representatives

Editorial One method used by companies to promote their health products is through sales representatives who meet with healthcare professionals at their place of work, otherwise known as detailing. Prescrire has been documenting the harmful effects of the biased information spread through this practice and its impact on prescribing for 40 years now.
Full article available for download (free)

1 March 2024

Voxelotor (Oxbryta°) in sickle-cell disease

Marketing Authorisations Voxelotor binds to haemoglobin and increases its affinity for oxygen. It is claimed that this prevents sickling and premature destruction of red blood cells. A reduction in oxygen release by haemoglobin would be expected in its presence. Voxelotor has been authorised in the European Union for the treatment of haemolytic anaemia due to sickle-cell disease, as monotherapy or in combination with hydroxycarbamide. In this situation, does voxelotor correct the clinical effects of anaemia or reduce the the incidence of complications of sickle-cell disease?
Full article available for download by subscribers

1 March 2024

Pregabalin and gabapentin: sometimes fatal overdoses

Adverse effects Various studies have confirmed that pregabalin overdose carries a risk of coma and respiratory depression. The risk of overdose is increased in patients with renal impairment. The severity of such overdoses is increased when pregabalin is combined with a central nervous system depressant such as an opioid. Gabapentin also carries a risk of overdose in the presence of renal impairment.
Full article available for download by subscribers

1 March 2024

Intranasal fentanyl (Instanyl° Doseguard°): finally made safer

Marketing Authorisations The new multidose presentation of fentanyl solution for intranasal administration, Instanyl° DoseGuard°, is safer for patients than the former presentation, as it is equipped with a safety cap, an electronic dose counter, and a mechanism to temporarily prevent any further administration within a given time period.
Full article available for download by subscribers

1 March 2024

Medical devices mimicking medicinal products: the European Court of Justice confirms a strict stance

Outlook In early 2023, the European Court of Justice upheld a legal ruling from Germany challenging the status of two medical devices that consisted exclusively of chemical substances and resemble medicinal products. Certification bodies or authorities are justified in denying medical device status to products of this kind for which a lack of pharmacological action has not been demonstrated.
Full article available for download by subscribers

1 March 2024

Leave my placenta alone!

Editorial Prescrire has a longstanding interest in the consequences of drug exposure during pregnancy, for both the woman and the unborn child. This interest extends to women who are not yet aware they are pregnant, and to the long-term consequences of in-utero drug exposure, in particular on the child's development.
Full article available for download (free)

1 February 2024

Olaparib (Lynparza°) as "maintenance" therapy for certain advanced ovarian cancers after first-line chemotherapy

Marketing Authorisations Olaparib is authorised as "maintenance" treatment (with or without bevacizumab) in women with certain ovarian cancers following first-line chemotherapy. In both authorised clinical situations, the initial authorisation was based on a single double-blind randomised clinical trial, with an interim analysis showing no reduction in mortality after a median follow-up of about 40 months. As of mid-2023, longer-term results are available from both of these trials.
Full article available for download by subscribers

1 February 2024

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