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07/06/2006
Prozac recommended for eight-year-olds
Prozac can be prescribed for children as young as eight, the European Medicines Agency has said.
The EMEA recommended to extend the indication for Prozac, or fluoxetine, to include the treatment of children of eight years of age or older who suffer from moderate to severe depression and who do not respond to psychological therapy.
In April 2005, the Agency's Committee for Medicinal Products for Human Use had ruled that warnings should be included in the product information of the class of serotonin selective re-uptake inhibitor medicines, or SSRIs, including Prozac, regarding the increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility in children and adolescents using antidepressants.
However, following a review, the CHMP concluded that the benefits of using Prozac outweighed the risks. However, it said that the manufacturers of the drug, Eli Lilly, should carry out additional studies to ensure that the safety profile of the drug remained acceptable.
The CHMP review found that Prozac had a "positive effect" on children and adolescents. However, it recommended that the drug should only be used along with psychological therapy in patients not responding to therapy alone after four to six sessions.
The CHMP said that a starting dose of 10mg per day should be used for under-eighteens, which could be increased to 20mg per day after one to two weeks. However, if no clinical benefit was seen within nine weeks, treatment should be reconsidered, the CHMP said.
The CHMP said that the significance of the observations in animal studies on sexual development, emotional behaviour and testicular toxicity would be further investigated and a system would be put in place to obtain safety data in treated children, particularly in relation to sexual development.
The CHMP also stressed that doctors and parents should also carefully monitor any children and adolescents taking Prozac for suicidal behaviour, particularly at the beginning of treatment.
(KMcA)
The EMEA recommended to extend the indication for Prozac, or fluoxetine, to include the treatment of children of eight years of age or older who suffer from moderate to severe depression and who do not respond to psychological therapy.
In April 2005, the Agency's Committee for Medicinal Products for Human Use had ruled that warnings should be included in the product information of the class of serotonin selective re-uptake inhibitor medicines, or SSRIs, including Prozac, regarding the increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility in children and adolescents using antidepressants.
However, following a review, the CHMP concluded that the benefits of using Prozac outweighed the risks. However, it said that the manufacturers of the drug, Eli Lilly, should carry out additional studies to ensure that the safety profile of the drug remained acceptable.
The CHMP review found that Prozac had a "positive effect" on children and adolescents. However, it recommended that the drug should only be used along with psychological therapy in patients not responding to therapy alone after four to six sessions.
The CHMP said that a starting dose of 10mg per day should be used for under-eighteens, which could be increased to 20mg per day after one to two weeks. However, if no clinical benefit was seen within nine weeks, treatment should be reconsidered, the CHMP said.
The CHMP said that the significance of the observations in animal studies on sexual development, emotional behaviour and testicular toxicity would be further investigated and a system would be put in place to obtain safety data in treated children, particularly in relation to sexual development.
The CHMP also stressed that doctors and parents should also carefully monitor any children and adolescents taking Prozac for suicidal behaviour, particularly at the beginning of treatment.
(KMcA)
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