Archives : 2023

No regard for patients!

Editorial Risperidone for monthly injection (Okedi°) was granted marketing authorisation on the basis of a randomised placebo-controlled trial in patients experiencing an acute exacerbation of schizophrenia (see “Risperidone as monthly injections” Prescrire Int n° 252 > Subscribers only). This placebo-controlled trial was doubly disgraceful.

1 October 2023

Rimegepant (Vydura°) in migraine

Marketing Authorisations Rimegepant is another CGRP receptor antagonist, with a chemical structure completely different from that of the monoclonal antibodies initially available. It is the first CGRP inhibitor to be authorised in the European Union for oral administration, both for the treatment and prevention of migraine attacks.
Full article (4 pages) available for download by subscribers

1 October 2023

Lenacapavir (Sunlenca°) in multidrug-resistant HIV-1 infection

Marketing Authorisations Lenacapavir is an antiretroviral drug that binds to the HIV-1 capsid. This disrupts various steps in the HIV lifecycle in which the capsid plays a role, such as transport of the viral genome into the nucleus of an infected cell, integration of the viral genome, and assembly of various viral components. It is the first antiretroviral with this mechanism of action to have been authorised in the European Union.
Full article (3 pages) available for download by subscribers

1 October 2023

Cannabidiol: sometimes serious adverse effects, and multiple drug interactions

Adverse Effects Cannabidiol (CBD), a cannabinoid, is naturally present in cannabis. Cannabidiol is used as an antiepileptic. Some CBD-containing products are sold without the regulatory status of medicines, and sometimes also contain other cannabinoids.
Full article (1 page) available for download by subscribers

1 October 2023

Drug shortages: patients lose out, healthcare professionals waste time

Outlook Drug shortages expose patients to a risk of serious, sometimes fatal, adverse effects, medication errors, and worsening of their disease. In daily practice, the workload of healthcare professionals is increased, with harmful consequences for the healthcare system, exacerbating an already fragile situation. In 2020-21, using the French pharmacovigilance database, France’s regional pharmacovigilance centres (CRPV) carried out a study on the consequences of drug shortages.
Full article (2 pages) available for download by subscribers

1 October 2023

Prescrire: a cosignatory of letters to various European institutions

Advancing Healthcare Policy In late 2022, Prescrire was a cosignatory of letters to three institutions in Europe: the Council of the European Union, the European Patent Office, and the European Parliament's Special Committee tasked with evaluating the handling of the covid-19 pandemic.

1 October 2023

Publication of clinical trial protocols

Advancing Healthcare Policy In a joint letter to the European Medicines Agency's Management Board, Prescrire contested an Agency plan that would delay publication of the protocols of drug trials.

1 October 2023

Practicalities

Editorial A drug is more than just an active substance mixed with excipients. There is more to consider than its pharmacological properties or its economic success. A drug is also a physical product that is part of the patient's daily life. And its packaging components, such as its box, the blister packs, bottle, vial or syringe, and the patient leaflet, are an integral part of this.

1 September 2023

Nivolumab (Opdivo°) in advanced gastric or oesophageal cancer

Marketing Authorisations Nivolumab, a monoclonal antibody directed against PD-1, has been authorised for patients with metastatic or inoperable gastric or oesophageal adenocarcinoma or squamous cell carcinoma. In these situations, does nivolumab represent a therapeutic advance compared to the treatments already available, and, in particular, does it extend survival?
Full article (3 pages) available for download by subscribers

1 September 2023

Dulaglutide, exenatide, liraglutide and other GLP-1 receptor agonists: thyroid cancer

Adverse Effects In 2022, a French research team published a case-control study which investigated the association between exposure to a GLP-1 receptor agonist and the risk of developing thyroid cancer.
Full article available for download by subscribers

1 September 2023

Glucarpidase (Voraxaze°) for high-dose methotrexate toxicity

Marketing Authorisations Glucarpidase has been granted marketing authorisation in the European Union for reducing plasma concentrations of methotrexate in patients who have received high-dose methotrexate for cancer treatment when elimination is delayed due to impaired renal function. In this situation, does glucarpidase reduce an excessively high plasma concentration of methotrexate? Does it limit the serious dose-dependent adverse effects of this cytotoxic drug? And what are its adverse effects?
Full article (2 pages) available for download by subscribers

1 September 2023

Prescrire's annual review of drug packaging: progress is too slow

A drug's packaging contains a set of components for use by patients, their caregivers and healthcare professionals. It is important that packaging is well designed with a view to ease of use and the prevention of errors with dangerous consequences.
Full article (4 page) available for download (free)

1 September 2023

R&D costs: secrecy at every level

In France, the pharmaceutical industry has managed to turn a law to ensure transparency about the public funding it receives into a promotional opportunity.
Full article available for download (free)

1 September 2023

Conditional marketing authorisation: easier to grant than to revoke

Progesterone is ineffective at preventing preterm delivery, but proved difficult to withdraw from the market. It is not the only example of this phenomenon.
Full article available for download (free)

1 September 2023

Interdisciplinary collaboration

Editorial Many healthcare professionals routinely provide care for a specific patient by working together or as part of a multidisciplinary team. When well organised, such collaborations are synergistic, and beneficial for patients.

1 July 2023

Daridorexant (Quviviq°) in insomnia

Marketing Authorisations The clinical evaluation of daridorexant in patients with chronic insomnia was not designed to demonstrate a potential advance compared with already available sleep-inducing drugs. While its mechanism of action is indeed different, there is no evidence that it represents a tangible clinical advance for patients.
Full article (4 pages) available for download by subscribers

1 July 2023

Clinical trials in children: many results go unreported

A group of US researchers have determined the proportion of clinical trials in children that were stopped prematurely, as well as the proportion of completed trials whose results were not reported.

1 July 2023

"Hybrid closed-loop" systems for blood glucose control: another way of delivering intensive insulin therapy

"Hybrid closed-loop" systems for blood glucose control in type 1 diabetes appear to maintain blood glucose close to physiological levels slightly more of the time than a "conventional" insulin pump, in particular at night. However, they also appear to slightly increase the incidence of hyperglycaemic episodes, mainly through malfunctions.
Full article (4 pages) available for download by subscribers

1 July 2023

Venlafaxine in the first trimester of pregnancy: possible risk of birth defects, especially cardiac malformations

Adverse Effects Venlafaxine is more dangerous than "selective" serotonin reuptake inhibitor antidepressants. It has been on Prescrire's list of drugs to avoid since 2014. As of 2023, various studies have shown that venlafaxine use during the first trimester of pregnancy carries a risk of birth defects, especially cardiac malformations.
Full article (2 pages) available for download by subscribers

1 July 2023

Good sources

Editorial The most robust evidence of a treatment's efficacy comes from comparative trials, conducted in accordance with a rigorous methodology to ensure that the comparison was not biased. Yet few health professionals have both the time and experience required to analyse trials themselves and put their results into perspective.

1 June 2023

Ivacaftor + tezacaftor + elexacaftor (Kaftrio°) in cystic fibrosis with at least one delta F508 mutation from 6 years of age

Marketing Authorisations Triple therapy with the CFTR modulators ivacaftor + tezacaftor + elexacaftor was initially authorised in the European Union for adults and adolescents who have cystic fibrosis with a delta F508 mutation on at least one of the CFTR alleles. It has also been authorised for use in children in the same situation, aged 6 years and older.
Full article (2 pages) available for download by subscribers

1 June 2023

Drug-induced impairment of lactation

Adverse Effects There are numerous causes of insufficient maternal milk production. It is often due to insufficiently frequent suckling and/or failure to "empty" the breasts sufficiently, for example because of nipple disorders. Sometimes, however, drugs are to blame.
Full article (4 pages) available for download by subscribers

1 June 2023

Proving a treatment's efficacy

Outlook What is the best way to demonstrate a treatment's efficacy? In other words, how do you establish a causal relationship between the treatment and a clinical improvement of sufficient value that it justifies the risk of experiencing the treatment's known, and as yet unknown, harms?

Full article (4 pages) available for free download.

1 June 2023

Difelikefalin (Kapruvia°) in pruritus associated with chronic kidney disease

Marketing Authorisations Difelikefalin is the first drug to be authorised in the European Union for the treatment of moderate to severe pruritis associated with chronic kidney disease in patients on haemodialysis.
Full article (4 pages) available for download by subscribers

1 June 2023

Prescrire's finances: 2022 annual report

Every year, Association Mieux Prescrire, the legal entity responsible for Prescrire's publications, publishes a summary of its annual financial report in the March issue of Prescrire and in the June issue of Prescrire International. The summary of its 2022 annual report is publicly available here.

1 June 2023

Recombinant Beta variant covid-19 vaccine with adjuvant (Vidprevtyn Beta°), as a booster

COVID-19 The recombinant Beta variant covid-19 vaccine with AS03 adjuvant was authorised in the European Union in mid-November 2022, for use only as a booster in adults who have already received an mRNA or viral-vector vaccine.
Full article (2 pages) available for download by subscribers

1 June 2023

A difficult choice

Editorial Corticosteroids have been used for a very long time, and a great deal is known about their adverse effect profile. In some chronic inflammatory diseases, other drugs with immunosuppressive effects are proposed, with the aim of reducing corticosteroid use. These drugs' adverse effects differ in part from those of corticosteroids, but some of them may not yet be known.

1 May 2023

Anifrolumab (Saphnelo°) in systemic lupus erythematosus after failure of standard therapy

Marketing Authorisations Anifrolumab is a monoclonal antibody that inhibits receptors for type I interferons. This immunosuppressant has been authorised in the European Union as add-on therapy for patients with systemic lupus erythematosus in whom standard treatment has been insufficiently effective.
Full article (3 pages) available for download by subscribers

1 May 2023

Dabigatran (Pradaxa°) for venous thrombosis in children and adolescents

Marketing Authorisations Dabigatran, an anticoagulant of the thrombin inhibitor class authorised for use in adults after venous thrombosis, a situation in which it does not represent a therapeutic advance, has now also been authorised for patients less than 18 years of age.
Full article (2 pages) available for download by subscribers

1 May 2023

Janus kinase inhibitors: higher incidence of serious adverse effects and death than with TNF-alpha inhibitors

Adverse Effects The increased incidence of serious adverse effects associated with tofacitinib and baricitinib, and probably also the three other JAK inhibitors used in chronic inflammatory diseases, raises questions about the harm-benefit balance of drugs of this class.
Full article (1 page) available for download by subscribers

1 May 2023

Spotlight: Archives

Spotlight

2023

No regard for patients!

Rimegepant (Vydura°) in migraine

Lenacapavir (Sunlenca°) in multidrug-resistant HIV-1 infection

Cannabidiol: sometimes serious adverse effects, and multiple drug interactions

Drug shortages: patients lose out, healthcare professionals waste time

Prescrire: a cosignatory of letters to various European institutions

Publication of clinical trial protocols

Practicalities

Nivolumab (Opdivo°) in advanced gastric or oesophageal cancer

Dulaglutide, exenatide, liraglutide and other GLP-1 receptor agonists: thyroid cancer

Glucarpidase (Voraxaze°) for high-dose methotrexate toxicity

Prescrire's annual review of drug packaging: progress is too slow

R&D costs: secrecy at every level

Conditional marketing authorisation: easier to grant than to revoke

Interdisciplinary collaboration

Daridorexant (Quviviq°) in insomnia

Clinical trials in children: many results go unreported

"Hybrid closed-loop" systems for blood glucose control: another way of delivering intensive insulin therapy

Venlafaxine in the first trimester of pregnancy: possible risk of birth defects, especially cardiac malformations

Good sources

Ivacaftor + tezacaftor + elexacaftor (Kaftrio°) in cystic fibrosis with at least one delta F508 mutation from 6 years of age

Drug-induced impairment of lactation

Proving a treatment's efficacy

Difelikefalin (Kapruvia°) in pruritus associated with chronic kidney disease

Prescrire's finances: 2022 annual report

Recombinant Beta variant covid-19 vaccine with adjuvant (Vidprevtyn Beta°), as a booster

A difficult choice

Anifrolumab (Saphnelo°) in systemic lupus erythematosus after failure of standard therapy

Dabigatran (Pradaxa°) for venous thrombosis in children and adolescents

Janus kinase inhibitors: higher incidence of serious adverse effects and death than with TNF-alpha inhibitors