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18/02/2005
MHRA reissues antidepressant advice
The Medical and Healthcare Products Regulatory Agency (MHRA) has resissued recent advice on SSRIs, following a number of studies published in the latest edition of the British Medical Journal (BMJ).
An article in this week's BMJ claims that selective serotonin reuptake inhibitors (SSRIs), which are the most commonly prescribed form of antidepressant, may induce or worsen suicidal feelings in vulnerable patients.
The BMJ published three studies to back up the claims. The first study found that patients taking SSRIs were twice as likely to attempt suicide than those taking placebos, although no risk increase was found in fatal suicide attempts between SSRIs and placebo. The study also found that there was no difference between patients taking SSRIs and other antidepressants – known as tricyclic antidepressants.
However, the second study found that there was no increased of suicide or suicidal thoughts in patients taking SSRIs, although they did find some evidence of an increase in the risk of self-harming. The authors said that increased risks of suicide and self-harm could not be ruled out and larger trials over longer periods were required.
The final study found no difference in self-harm and suicide risks between patients prescribed SSRIs and those taking tricyclic antidepressants, although they suggested that under-eighteens prescribed SSRIs seemed to be more at risk of self-harm.
The BMJ said that these studies provided "useful insights" and would make doctors aware that patients taking SSRIs and tricyclics needed close monitoring. The BMJ also said that the prescription of antidepressant drugs to children and adolescents should bediscouraged.
Kamran Abbasi, BMJ Acting Editor, said:"The debate is not yet done, but these papers crystallise arguments that have been drifting in the ether these past months. How many people who turned to 'happy pills' would not have done so if they had been fully aware of the potential harms?"
The MHRA convened an Expert Working Group to review evidence on SSRIs in 2004. Its advice, which was published in 2004, suggested that a "moderate increase" in suicidal thoughts and self-harm among SSRIs could not be ruled it and stressed the importance of careful and frequent monitoring of patients. The group also considered evidence on withdrawal reactions and dose response and made recommendations in these areas.
Professor Ian Weller, Chair of the Expert Working Group, said that the studies published in the BMJ had already been considered by the group, along with all the other evidence and, in view of this, the group did not need to alter its recommendations. Professor Weller said: "SSRIs are an important group of medicines which have made a vital contribution to improving the lives of many patients who are living with moderate to severe depression. The balance of risks and benefits remains positive in those groups of patients for whom this medicine is licensed. However, depression is a serious condition and these are powerful medicines, and just like any medicine they can have side effects. It is important that people are aware of the side effects so that they can be alert to any possible concerns during treatment. That is why the group has made its recommendations available to patients and to healthcare professionals".
(KMcA/SP)
An article in this week's BMJ claims that selective serotonin reuptake inhibitors (SSRIs), which are the most commonly prescribed form of antidepressant, may induce or worsen suicidal feelings in vulnerable patients.
The BMJ published three studies to back up the claims. The first study found that patients taking SSRIs were twice as likely to attempt suicide than those taking placebos, although no risk increase was found in fatal suicide attempts between SSRIs and placebo. The study also found that there was no difference between patients taking SSRIs and other antidepressants – known as tricyclic antidepressants.
However, the second study found that there was no increased of suicide or suicidal thoughts in patients taking SSRIs, although they did find some evidence of an increase in the risk of self-harming. The authors said that increased risks of suicide and self-harm could not be ruled out and larger trials over longer periods were required.
The final study found no difference in self-harm and suicide risks between patients prescribed SSRIs and those taking tricyclic antidepressants, although they suggested that under-eighteens prescribed SSRIs seemed to be more at risk of self-harm.
The BMJ said that these studies provided "useful insights" and would make doctors aware that patients taking SSRIs and tricyclics needed close monitoring. The BMJ also said that the prescription of antidepressant drugs to children and adolescents should bediscouraged.
Kamran Abbasi, BMJ Acting Editor, said:"The debate is not yet done, but these papers crystallise arguments that have been drifting in the ether these past months. How many people who turned to 'happy pills' would not have done so if they had been fully aware of the potential harms?"
The MHRA convened an Expert Working Group to review evidence on SSRIs in 2004. Its advice, which was published in 2004, suggested that a "moderate increase" in suicidal thoughts and self-harm among SSRIs could not be ruled it and stressed the importance of careful and frequent monitoring of patients. The group also considered evidence on withdrawal reactions and dose response and made recommendations in these areas.
Professor Ian Weller, Chair of the Expert Working Group, said that the studies published in the BMJ had already been considered by the group, along with all the other evidence and, in view of this, the group did not need to alter its recommendations. Professor Weller said: "SSRIs are an important group of medicines which have made a vital contribution to improving the lives of many patients who are living with moderate to severe depression. The balance of risks and benefits remains positive in those groups of patients for whom this medicine is licensed. However, depression is a serious condition and these are powerful medicines, and just like any medicine they can have side effects. It is important that people are aware of the side effects so that they can be alert to any possible concerns during treatment. That is why the group has made its recommendations available to patients and to healthcare professionals".
(KMcA/SP)
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