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Charities positive about Prozac use

Recommendations from the EMEA on the use of Prozac in children has been well received by leading mental health charities

Children's and mental health charities have reacted positively to recommendations from the European Medicines Agency (EMEA) for the use of Prozac in children over eight years old if talking therapies and other forms of counselling do not work.

"While medication for the young should always be monitored, depression in children can be so destructive to their future and harrowing for their families that no treatment should be ruled out,î said Marjorie Wallace, chief executive of the mental health charity, SANE.

ìAll medication, if effective, must be considered on a balance of risk and benefit. We should not deprive children any more than we should deprive adults of available means of saving at least some many years of loneliness and despair," she added.

However, YoungMinds, the national charity dedicated to the mental needs of children and young people, has said that prescription medication should never be the first course of action, but admitted that there may be specific circumstances where psychological treatment alone is not effective for the child.

ìWhenever children experience mental illness an holistic approach to treatment and care is essential. This would include a package of care designed to ensure the best chance of recovery. After careful consideration and consultation with the child, their family and medical team, such treatments may be offered alongside other therapy,î said YoungMinds' development director, Avis Johns.

ìThough quite rare, the ability to combine a range of therapies with appropriate medication can provide significant benefits,î she added.

The European regulator has adopted a positive view on the use of Prozac and associated names for use in children and adolescents with moderate-to-severe depression, after its Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of using Prozac for this indication outweigh its potential risks.

Lilly filed an application to extend the indications to include major depressive episodes in children after a request from the UK. The company, which holds the marketing authorisation for Prozac for use in adults, first launched the product in 1986.

A licence for the product in this expanded indication has not yet been granted. The EMEA is meeting in August to discuss marketing authorisation for the product for use in children and there is every reason to be believe that it will be granted, as it is unusual for the regulator to rule against advice.

However, under licence, the EMEA will impose restrictions on the use of Prozac, the only selective serotonin re-uptake inhibitor (SSRI) the Medicine and Healthcare products Regulatory Agency has exempted from its general ban for use in children, which stipulate that the drug cannot be prescribed for use in children unless talking therapies have failed.

The regulator is also likely to impose other caveats on use of the product on advice from the CHMP which, as well as advising its use only in patients who do not respond to talking therapies, concluded that the starting dose should be 10mg per day (given as 2.5ml of oral solution) and may be increased to 20mg per day after 1-2 weeks, and treatment should be reconsidered after 9 weeks if there is no clinical benefit. In addition, Lilly has been told to put in place a system to obtain safety data in children taking Prozac, with particular emphasis on sexual development.

The CHMP has confirmed that doctors and parents should carefully monitor children and adolescents for suicidal behaviour, particularly at the beginning of their treatment.

Message to healthcare professionals
For healthcare professionals, the potential licensing approval for Prozac in this new indication represents a new stage in the treatment of depression in children. However, as the drug is not a first line treatment, healthcare professionals are unlikely to need re-educating as to its uses.

ìProzac is not intended as a first line treatment for children,î said a spokesman for Lilly UK. ìThey will first have to have 4-6 talking therapy sessions. If this is not sufficient, a low dose of Prozac can be prescribed, alongside more counselling. Our message [should a licence be granted] will be to reinforce this.î

He stressed that ìProzac is for moderate-to-severe depression, it's not just for those who feel a bit down, but for those who are potentially suicidalî.

For Lilly, the possibility of an expanded licence for Prozac, which has been off-patent and subject to generic erosion for a number of years, will have little impact.

30th September 2008

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