The growth in withdrawals also derives from greater efficiency in prevention
Sarah Todaro
The quota nimesulide; the antitussive syrup that hurts the heart; the packages withdrawn from the market because the dose is not the right one... Alerts on the drugs we use every day are increasingly frequent, but they are "a good sign", even if often the public and healthcare professionals themselves seem "incapable of perceiving the need of a continuous review of the risk/benefit profile of the drugs». Thus sounds, a little hard-nosed, the clarification - perhaps necessary - with which the latest issue of the Aifa (the Italian Medicines Authority) bulletin of information on drugs takes stock of the subject of "Pharmacovigilance".
A necessary clarification, after the prominence given by the news to the news of the possible liver damage linked to the use of nimesulide.
The story is known: AIFA imposed the non-repeatable prescription (usable only once) for nimesulide at the end of the review of the safety profile by the EMEA (EU Medicines Agency). Revision triggered - as required by the Community Code of Medicines - for the choice of a member state, Ireland, to prevent its marketing in its territory. The news caused a sensation, but is now almost forgotten. Actually "outdated".
At the end of October, another warning exploded from the EMEA game bag: "There is an antitussive syrup that can hurt the heart: it is better to stop using it, given that there are less risky alternative treatments on the market". This time the sentence concerned clobutinol-based antitussives ("over-the-counter" medicines, which can be purchased without a prescription in many EU countries): also in this case, the review on the risk/benefit ratio was triggered by the thumbs down of a state member – Germany – which has suspended its marketing since September.
Three more reports in November: the suspension throughout Europe of a well-known painkiller; the warning about the risks of serious hypersensitivity in relation to an osteoporosis treatment; updated safety information on the use of an anti-rejection drug during pregnancy.
Different sides of the same coin: more checks, more reports - even from companies - more efficiency in preventing risks. "The re-evaluation of the benefit/risk profile - writes AIFA - is not an implicit admission of guilt, nor is it a symptom of a system that fails in its mission to avoid unnecessary risks".
Between 2001 and 2007, at least ten products were withdrawn by the EU supervisory network in relation to the serious adverse reactions caused by their use. And according to the objectives of the EMEA "Road map" for 2010, surveillance and monitoring will only increase. In fact, the Agency has just launched the creation of Encept, the European network of pharmacovigilance and pharmacoepidemiology centres: the aim is to create an ad hoc network for post-marketing studies.
To date, 63 centers have been identified, of which 5 in the pediatric area: the pool includes, among other things, 22 centers with expertise in the cardiovascular area, 19 centers in the neurological area, seven centers in the endocrinology and diabetes area. Among the Italians, the Mario Negri Institute of Milan, the Pharmacology sections of the Universities of Verona and Messina, the CeVEAS (Centre for the evaluation of the effectiveness of health care) of Modena, the Biostatistics unit of the University of Milan-Bicocca.
The problem will be the funds: the EMEA will contribute with the funding raised in the context of EU research projects; the rest will come from signed contracts
