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Prescrire looks back at new drugs and new indications in 2010:
inadequate assessment; patients at risk

FEATURED REVIEW Prescrire's annual recap of new drugs and new indications reviewed last year in our French edition reveals that almost one-fifth of the new products approved were authorised in spite of a negative harm-benefit balance.
Full review (6 pages) available for free download.


  • In 2010, we rated 97 new drugs or new indications in our French edition la revue Prescrire, only 4 of which provided a therapeutic advantage. However, 19 others (1 in 5) were approved despite having more harms than benefits.
  • More paediatric products were released in 2010 than in previous years, but few of them made any real difference and many had not been properly evaluated.
  • Drug regulatory agencies can protect patients from exposure to dangerous drugs by refusing to grant market approval or by demanding their market withdrawal. Yet they are failing to fulfil this responsibility: so-called risk management plans and modifications to the wording in the SPC are only half-measures.
  • Too often the authorities put companies’ short-term financial interests above patients’ well-being by granting premature marketing authorisation, by agreeing to high levels of reimbursement that fail to take added therapeutic value into account, and by allowing the development of “umbrella” ranges.
  • The European authorities’ questionable plans for pharmacovigilance and advertising of prescription-only drugs were restricted after public mobilisation, but they are still likely to undermine healthcare quality.
  • Decision-makers must make patients’ well-being their top priority.

> Download the full text (Pdf, free).

> Click here for Prescrire's online Dossier, The Prescire Awards

©Prescrire 1 April 2011

"New drugs and indications in 2010: inadequate assessment; patients at risk" Prescrire Int 2011; 20 (115): 105-110. (Pdf, free)

Download the full review.
Pdf, free

The Prescrire Awards
(February 2011)