Drug regulatory agencies are mandated to protect patients’ health. Unfortunately, they will be unable to fulfil this role as long as they, and many of the experts who sit on their committees, are financially dependent on drug companies (Rev Prescrire 306, Prescrire Int 100). Many examples of agencies’ failure to protect patients were again observed in 2009.
Market withdrawals of harmful drugs: too few, too slow
In 2009, 3 drugs were withdrawn from the European market because of their adverse effects: benfluorex (an amphetamine marketed for more than 30 years in France), because of neuropsychological and cardiovascular disorders (including pulmonary hypertension and valve disease) (Prescrire Int 101 and 105); efalizumab, a drug authorised 5 years previously for psoriasis, despite its clearly negative riskbenefit balance (Rev Prescrire 306 and Prescrire Int 103); and injectable propacetamol, because of the increased risk of cutaneous disorders compared with injectable paracetamol (Rev Prescrire 313).
Many more drugs with unfavourable risk-benefit balances remain on the market, some of which have been around for decades.
Information about adverse effects: withheld or barely visible
Adverseeffects identified after a product has been markovienne are added to the summary of product characteristics (SPC), but these so-called variations are generally difficult to find, given the large volume of other information in the SPC.
Since 2004, the European Medicines Agency (EMA) has listed "major" variations in a document called "Steps taken after authorisation" on its website. This makes it easier for patients and healthcare professionals to find variations, but the information is often very brief and posted late. We regularly ask the EMA for access to specific data (see inset page 93). The French Health Products Safety Agency (Afssaps) does not publish a similar list of variations.
Thus, when the French agency does not disseminate information about a specific risk, it can only be identified through detailed comparison of successive versions of the SPC.
Important variations identified in 2009 illustrate the crucial need for transparency and public access to safety data: for example, cardiac disorders with domperidone (Rev Prescrire 313); increased risk of thrombosis with transdermal patches containing ethinylestradiol + norelgestromine (Rev Prescrire 311); cardiac and visual disorders with oseltamivir (Prescrire Int 102); a risk of suicide with varenicline (Rev Prescrire 311); and cardiac and hearing disorders with sildenafil, tadalafil and vardenafil (Rev Prescrire 306).
Refusal of marketing authorisation: an effective means of protection
In 2009, we welcomed decisions by the European Committee for Medicinal Products for Human Use (CHMP) to reject a number of marketing applications. Other applications were withdrawn by the companies concerned, after the CHMP issued an unfavourable opinion. These measures protected the public from exposure to unjustified risks.
Examples include: desvenlafaxine in depression, because of more cardiac adverse effects than with other antidepressants (Prescrire Int 103); ramelteon, a melatonin receptor agonist for insomnia, because its adverse effects far outweigh its efficacy (Prescrire Int 101).
©Prescrire April 2010
Source: "A look back at 2009: one step forward, two steps back" Prescrire Int 2010; 19 (106): 89-94.
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