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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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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

France's health technology assessment body: pushed to lower the bar!

Outlook The HAS's new principles for rating drugs, designed to facilitate access to new treatments, allow lower-quality evaluation. This may not be in patients' best interests.
Full article available for download (free)

1 December 2023

Drugs to avoid: an analysis of Australia’s pharmaceuticals market

Outlook A study by Australian academics, based on Prescrire’s annual review of drugs to avoid.
Full article available for download (free)

1 December 2023

Proposed multi-stakeholder platform to improve clinical trials in the European Union

Advancing Healthcare Policy Prescrire has responded to the consultation on the proposed key priorities for the platform, but chose not to apply for membership, in order to safeguard its independence.
Full article available for download (free)

1 December 2023

Flexibility

Editorial Healthcare professionals often specify how and when medicines should be taken when prescribing, dispensing or administering them, whether or not this information is included in the patient leaflet. These instructions are usually based on information provided in the summary of product characteristics, but is the level of evidence sufficiently strong to serve as a basis for hard and fast rules?
Full article available for download (free)

1 November 2023

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