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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

Clomifene: serious, sometimes irreversible, vision disorders  Adverse effects   In 2023, a US team published a case report of a 39-year-old woman who had, for 3 days, been taking 100 mg per day of clomifene (Clomid° or other brands), an oestrogen agonist/antagonist used to treat infertility by inducing ovulation. The woman described visual disturbances characterised by a blurry trail of multiple images persisting behind her hand as she moved it across her field of view. Full article available for download by subscribers 1 February 2024

Drugs that interfere with the placenta and affect the fetus  Adverse effects   The consequences of drug use on the placenta remain little studied as of 2023. Pharmacological knowledge about the substance in question helps to predict its impact on placental development and function, at all stages of pregnancy. Full article available for download by subscribers 1 February 2024

European Commission: taken to task by the Ombudsman for lack of transparency  Outlook   Following complaints on excessive response times, the European Ombudsman has reminded the European Commission that EU citizens have the right to access administrative documents and that access delayed is access denied. Full article available for download (free) 1 February 2024

Drugs to avoid in the name of better patient care: 2024 update  DRUGS TO AVOID - 2024 UPDATE   To make it easier to choose high-quality care, and to prevent disproportionate harm to patients, Prescrire has published its annual update of drugs to avoid. Full article (11 pages) available for download (free) 1 February 2024

Revision of European pharmaceutical legislation  Outlook   The European Parliament is set to vote on a proposed new regulation and directive in spring 2024. Prescrire has proposed a number of amendments. Full article available for download (free) 1 February 2024

Safety signals: why bother?  Editorial  A drug is a serious affair. With serious medical and ethical aspects, as well as economic and financial implications, to consider. It is the culmination of lengthy laboratory-based and clinical research. When the first safety signal appears, it would be unreasonable to tear down all that has been accomplished and waste all of the economic benefits at the drop of a hat. Full article available for download (free) 1 January 2024

Abemaciclib (Verzenios°), palbociclib (Ibrance°) and ribociclib (Kisqali°) added to an aromatase inhibitor in certain breast cancers  Marketing Authorisations   Abemaciclib, palbociclib and ribociclib have been authorised since the late 2010s for use in postmenopausal women with locally advanced or metastatic breast cancer, whose tumour cells express hormone receptors but do not overexpress the HER2 protein. According to the initial clinical evaluation of each of these CDK 4/6 inhibitors ("ciclibs"), none of them extended survival, while an increased incidence of serious adverse effects was reported. With longer follow-up, does the addition of a CDK 4/6 inhibitor to an aromatase inhibitor extend survival? And what more is known about their adverse effects? Full article (3 pages) available for download by subscribers 1 January 2024

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