martedì 7 dicembre 2004

antidepressivi in GB

una segnalazione di Francesco Troccoli

First World
UK issues new guidelines for antidepressants, advises restricted use of Wyeth's Efexor
Candace Hoffmann

Il NICE (National Institute for Clinical Excellence), ossia l'agenzia
britannica equivalente alla FDA negli USA, ha prodotto nuove linee guida in cui si raccomanda maggiore cautela nell'impiego degli antidepressivi.
The UK's Medicines and Healthcare Products Regulatory Agency said Monday that the overall benefits of most SSRI antidepressants outweigh their risks, but did issue stronger warnings on their use, BBC News and other news sources report. The agency did, however, single out Wyeth's Effexor, which will result in a new, interim label that states, in part, that Effexor be prescribed only by specialists and that it should not be given to patients with heart disease.
The agency's move for Effexor, sold in the UK as Efexor, "follows evidence that Efexor is involved in a higher rate of deaths from overdose than other SSRIs and that it may affect heart function," BBC News reports. Wyeth announced that the agency called for interim product labelling changes for both Efexor and Efexor XL in the UK, and in a filing with the US Securities and Exchange Commission said that it plans to challenge the agency's action, as reported in iWon. The company said it would be discussing the matters with regulators worldwide.
The MHRA's report follows its review of SSRIs after safety concerns arose over their use. The agency said that SSRI antidepressants should carry stronger warnings about the risk of withdrawal reactions once the treatment is stopped, and in most cases, only the lowest doses should be prescribed. Additionally, young adults should be monitored closely when prescribed antidepressants, as reported in MSNBC. The review also concluded "that a modest increase in the risk of suicidal thoughts and self-harm among adults taking SSRIs compared with placebo could not be ruled out," as reported in MSNBC. Moreover, no antidepressant was recommended for the initial treatment of mild depression.
The National Institute for Clinical Excellence also issued new guidelines for patients prescribed antidepressants, and emphasised the benefit of non-drug interventions for patients suffering from anxiety disorders. NICE also did not recommend the use of an antidepressant for initial treatment of mild depression, BBC News reports. Nonetheless, if antidepressants are used, NICE did recommend the use of SSRI antidepressants such as Eli Lilly's Prozac and GlaxoSmithKline's Seroxat, sold as Paxil in the US.
A Glaxo spokesman said that the new guidelines clarified the use of the newer antidepressants, reports BBC News.