Agency warns of withdrawal risks for patients taking SSRIs
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《英国医生杂志》
Doctors prescribing selective serotonin reuptake inhibitors (SSRIs) to patients with depression and anxiety should warn them first of the risks associated with stopping the treatment, the Medicines and Healthcare Products Regulatory Agency (MHRA) has advised, after receiving recommendations from an expert group convened by the Committee on Safety of Medicines. Doctors should also monitor closely patients starting to use the drugs.
But the expert group found no evidence of more suicidal thoughts or tendencies among adults prescribed the drug than among those taking placebo or older tricyclic drugs.
This is despite the fact that the potential harmful effects of the drug in children are now widely recognised. The MHRA has issued warnings about the risk of self harm and suicidal thoughts in young people taking the drugs ( BMJ 2004;328: 3-4) and the Food and Drugs Administration in the United States has also heard reports of similar concerns ( BMJ 2004;329: 641, 18 Sep).
The yellow card system, a mechanism in the United Kingdom for reporting adverse reactions, had indicated that there might be similar effects in adults.
The expert working group concluded, "From the available clinical trial data, both published and unpublished, a modest increase in the risk of suicidal thoughts and self harm for SSRIs compared with placebo cannot be ruled out."
It added that, compared with other antidepressants, "there is insufficient evidence from clinical trial data to conclude that there is any marked difference between members of the class of SSRIs or between SSRIs and other antidepressants with respect to their influence on suicidal behaviour."
"The number of patients in the trials is not sufficient confidence intervals," said Kent Woods, chief executive of the MHRA. He added that, although the yellow card system could "generate a signal of the nature of the problem," it "cannot give you an indication of how common that problem is."
The expert group also warned that, given the concern about the use of SSRIs by children and adolescents, it is important for doctors to monitor closely young adults up to the age of 30.
It has also issued a warning that the serotonin and noradrenaline reuptake inhibitor venlafaxine should be prescribed only by psychiatrists and other medical practitioners with a special interest in mental health.
The expert group began its investigation in May 2003. According to Professor Woods, the committee looked at the results of 600 randomised controlled trials; the GP research database, which covered 146 000 patients; and spontaneous reports of suspected adverse reactions.
The National Institute for Clinical Excellence waited until the MHRA report was published before issuing its latest guidelines on treating people who have depression and anxiety. These recommend initial psychological treatment for people with mild and moderate depression, as they can be as effective as drug treatments. Where antidepressants are prescribed for moderate or severe depression, SSRIs should be used, it says.(Lynn Eaton)
But the expert group found no evidence of more suicidal thoughts or tendencies among adults prescribed the drug than among those taking placebo or older tricyclic drugs.
This is despite the fact that the potential harmful effects of the drug in children are now widely recognised. The MHRA has issued warnings about the risk of self harm and suicidal thoughts in young people taking the drugs ( BMJ 2004;328: 3-4) and the Food and Drugs Administration in the United States has also heard reports of similar concerns ( BMJ 2004;329: 641, 18 Sep).
The yellow card system, a mechanism in the United Kingdom for reporting adverse reactions, had indicated that there might be similar effects in adults.
The expert working group concluded, "From the available clinical trial data, both published and unpublished, a modest increase in the risk of suicidal thoughts and self harm for SSRIs compared with placebo cannot be ruled out."
It added that, compared with other antidepressants, "there is insufficient evidence from clinical trial data to conclude that there is any marked difference between members of the class of SSRIs or between SSRIs and other antidepressants with respect to their influence on suicidal behaviour."
"The number of patients in the trials is not sufficient confidence intervals," said Kent Woods, chief executive of the MHRA. He added that, although the yellow card system could "generate a signal of the nature of the problem," it "cannot give you an indication of how common that problem is."
The expert group also warned that, given the concern about the use of SSRIs by children and adolescents, it is important for doctors to monitor closely young adults up to the age of 30.
It has also issued a warning that the serotonin and noradrenaline reuptake inhibitor venlafaxine should be prescribed only by psychiatrists and other medical practitioners with a special interest in mental health.
The expert group began its investigation in May 2003. According to Professor Woods, the committee looked at the results of 600 randomised controlled trials; the GP research database, which covered 146 000 patients; and spontaneous reports of suspected adverse reactions.
The National Institute for Clinical Excellence waited until the MHRA report was published before issuing its latest guidelines on treating people who have depression and anxiety. These recommend initial psychological treatment for people with mild and moderate depression, as they can be as effective as drug treatments. Where antidepressants are prescribed for moderate or severe depression, SSRIs should be used, it says.(Lynn Eaton)