Guest guest Posted July 31, 2004 Report Share Posted July 31, 2004 > " SSRI-Research " <ssri-research > > Thu, 29 Jul 2004 22:23:16 -0400 > [sSRI-Research] US acts on drug suicide > warning > > US acts on drug suicide warning > > Sarah Boseley, health editor > Wednesday March 24, 2004 > The Guardian > http://society.guardian.co.uk/mentalhealth/story/0,8150,1176570,00.html > > Prozac, Seroxat and other commonly used > antidepressants of the same class must carry > warnings that children and adults might become > suicidal while taking them, the American drug > regulator said yesterday, increasing the pressure on > the UK to act. > The Food and Drug Administration (FDA) stopped short > of stating that the drugs can cause some people to > want to kill themselves, but made it clear it was a > possibility. Doctors should be aware that if a > patient's depression appeared to get worse, it > " could be due to the underlying disease or might be > a result of drug therapy " , the FDA said. > > David Healy, the consultant psychiatrist from north > Wales who raised concerns about suicidal thoughts > and the SSRI (selective serotonin reuptake > inhibitors) class of drugs, said yesterday that the > FDA announcement was very close to stating that the > drugs caused the problems that have been reported. > > " They won't use the 'cause' word all that quickly > but they have said this happens during the early > days of treatment and it also happens when you > change the dose. That is as causal as you can get, " > he said. > > " They are hedging their legal bets. Regulators are > at real risk of being brought to the courts by > pharmaceutical companies that are unhappy with what > they have done. " > > An expert working group was set up by the UK drug > regulator, the Medicines and Healthcare Products > Regulatory Agency (MHRA), last year to investigate > the allegations not only that the drugs made people > suicidal and aggressive, but also that they suffered > severe side-effects when they tried to stop taking > them. > > The group looked first at the clinical trial > evidence relating to children and found that there > were more suicides in those on SSRIs than on the > placebo. As a result, the MHRA banned the use of all > the drugs except Prozac by those under 18. > > But the working group is still examining the > evidence in adults. Richard Brook, chief executive > of the mental health charity Mind, resigned last > week from the group over the MHRA's reluctance to > reveal publicly that Seroxat over the minimum dose > of 20mg a day was ineffective and led to more > side-effects. He now thinks the MHRA should follow > the example of the US. > > " In view of this decision by the conservative FDA, I > think the MHRA must now immediately issue advice to > people in the UK over suicidality in adults, " he > said. > > " I fear they won't, because they have a reluctance > to engage proactively with this issue, and also > because they are concerned about the European > licence. " The drugs were licensed for the whole of > Europe and it is likely that the MHRA would want to > wait for a European consensus. > > The FDA says that patients on the drugs must be more > closely monitored for suicidal thoughts. Karen Barth > Menzies, a lawyer with Baum Hedland in the US, which > is pursuing legal claims against the companies, > welcomed the FDA statement, but regretted that it > had taken a decade of pressure to get the bold-print > warnings manufacturers will now have to include on > labelling. > > " Through our litigation over the past 13 years, > we've seen the internal documentation that shows the > drug companies have known that their drugs can cause > suicide and violence even before the drugs were > approved for marketing, " she said. " Moreover, both > the FDA and drug companies have known that these > drugs are only marginally effective in treating > depression, thus the perception that the benefits > outweigh the risks is based on misleading promotion > of the drugs' benefits. " > > > [Non-text portions of this message have been > removed] Quote Link to comment Share on other sites More sharing options...
Recommended Posts
Join the conversation
You are posting as a guest. If you have an account, sign in now to post with your account.
Note: Your post will require moderator approval before it will be visible.