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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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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

When the cause of a disorder is not immediately obvious: could a drug be responsible?

Outlook The potential role of a drug in the onset of a disorder is often overlooked or rarely considered. Yet many disorders are sometimes drug-induced, and in some cases this aetiology was long unsuspected or considered unlikely. This article discusses a few examples of clinical situations for which a drug-related cause was initially considered unlikely, but became credible over time.
Full article available for download by subscribers

1 January 2024

Prescribing cascades: recognise them and take corrective action

Adverse effects Using a systematic literature review, a research team identified situations in which a drug was prescribed to treat a disorder caused by another drug. Nine prescribing cascades turned out to be particularly problematic in older patients, due to their clinical consequences, the frequency with which the drugs involved were prescribed, or the severity of their potential adverse effects, yet alternatives were available.
Full article available for download by subscribers

1 January 2024

When to take a safety signal into account: Prescrire's experience

Outlook A large number of safety signals, suggesting the existence of previously unknown or incompletely documented adverse effects, can be found in numerous publications from a wide variety of sources. How can healthcare professionals tell which signals are worth taking into account in order to provide better patient care? This article is based on Prescrire's experience and continuous monitoring of the literature.
Full article (4 pages) available for download by subscribers

1 January 2024

Defending the right to compensation for the victims of drug-induced harms

Advancing Healthcare Policy Prescrire and France Assos Santé have proposed a series of amendments to members of the European Parliament working on the revision of the 1985 European Product Liability Directive.
Full article available for download (free)

1 January 2024

Patient characteristics

Editorial The best treatment option in a given clinical situation is the one that offers the best balance between efficacy and harm, making it the most suitable option for most patients. For most patients, but not all. Because sometimes a patient characteristic shifts this balance to a point where another treatment would be more suitable.
Full article available for download (free)

1 December 2023

Nirsevimab (Beyfortus°) to prevent RSV infection in infants

Marketing Authorisations Palivizumab was the first drug to receive European marketing authorisation for the prevention of RSV infection. Its use is restricted to certain infants at increased risk of developing severe disease. Nirsevimab, another monoclonal antibody directed against the RSV F protein, has been authorised for the prevention of RSV infection in neonates and infants, including those who have no risk factors for developing severe disease. Does nirsevimab reduce the incidence of severe RSV disease or death compared with palivizumab in infants with risk factors, or compared with placebo in healthy full-term infants?
Full article (3 pages) available for download by subscribers

1 December 2023

Negative post-marketing trials: often ignored

Outlook Accelerated or conditional marketing authorisation pathways are designed to speed up patient access to potential therapeutic advances. But when post-marketing trials conducted to evaluate these drugs using clinical endpoints do not confirm the pre-authorisation trial results obtained using surrogate endpoints, drug regulatory agencies and the organisations responsible for cancer guidelines rarely take these negative results into account.
Full article available for download by subscribers

1 December 2023

Ustekinumab (Stelara°): no live vaccines before 6 months of age for infants who have been exposed in utero

Adverse Effects Infants exposed in utero to an immunosuppressant such as ustekinumab are, as a result, susceptible to serious infections for several months after birth if they are given a vaccine containing live attenuated bacteria or viruses.
Full article available for download by subscribers

1 December 2023

Zonisamide: as dangerous as topiramate during pregnancy?

Adverse Effects The EMA has concluded that a pregnancy test should be "considered" before initiating treatment with zonisamide. Its close pharmacological similarity to topiramate, which has established teratogenic effects, plus the few available data, indicate the need for caution in women who are, or could become, pregnant.
Full article available for download by subscribers

1 December 2023

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