Users may have suicidal thoughts |
Children on a medicine for attention deficit hyperactivity disorder may be at increased risk of suicidal thoughts and behaviour, experts caution.
The Medicines and Healthcare products Regulatory Agency is warning doctors to be on the look out for warning signs.
It received 11 reports of suicidal thoughts or behaviour among an estimated 15,000 users of Strattera in the UK last year - mainly children.
Experts urged parents not to be alarmed saying the drug benefited many.
For the majority of children on Strattera (atomoxetine), the drug's benefits outweigh any risk and they should continue on the treatment, they said.
Doctors and patients, together with parents and guardians, are being advised of this risk and should be made aware of any possible signs and symptoms as a precautionary measure.
Updated warnings will be put on the drug's patient information leaflet.
The news follows recent reports of concerns about potential suicidal side effects of commonly used antidepressants among children and teenagers.
Dr June Raine of the MHRA said: "We are advising healthcare professionals that patients should be carefully monitored for signs of depression, suicidal thoughts or suicidal behaviour and referred for alternative treatment if necessary.
Suicidal thoughts
"Children who are doing well on this medication should continue their treatment.
"Those who experience any unusual symptoms, or are concerned, should speak to their doctor to discuss the best course of action."
The drug is one of many used to help control the symptoms of ADHD - inability to pay attention and impulsiveness and hyperactivity.
It was licensed in the UK in July 2004 and can be given to children aged six upwards.
The most commonly prescribed treatment for those with ADHD, however, remains the stimulant Ritalin (methylphenidate).
Andrea Bilbow, chief executive of the ADHD charity ADDISS, said: "The risk is very small. The benefits still likely outweigh any risk.
"Parents should not be alarmed. If a child is on Strattera and doing well, don't stop.
"If they are concerned, they should go and discuss this with their doctor. And doctors should be screening users for suicidal thoughts."
She said because of the nature of ADHD, many children with the condition were already vulnerable and at risk of suicidal thoughts and should be monitored regularly anyway.
"These kids what ever drug they are on do need to be monitored more often."
She said around 40,000 children in England and Wales had been diagnosed with ADHD and were on some form of medication for the condition.
However, because ADHD is under-recognised, as many as 400,000 could actually have the condition, or 5% of children.
The drug Strattera has also been linked to liver damage. "
http://www.mhra.gov.uk/news/strattera_qa_290905.pdf
TRANSCRIPT of PRESS RELEASE
"Press release
Date: Thursday 29 September
Time: 2.00pm
Subject: Strattera®
Contact: Press Office 0207 084 3535 / 3564
press.office@mhra.gsi.gov.uk
Out of hours 07770 446 189
_________________________________________________________________
Updated warnings on the risk of suicidal thoughts with Strattera®
The Medicines and Healthcare products Regulatory Agency (MHRA) is to
look into the health risks and benefits of Strattera®, a prescription-only medicine used to treat attention deficit hyperactivity disorder (ADHD). This follows new clinical trial data which identified an increased risk of suicidal thoughts and behaviour in children treated with Strattera®.
Strattera® is not extensively used in the UK for the treatment of ADHD, but patients together with parents and guardians are being advised of this risk and should be made aware of any possible signs and symptoms.
Dr June Raine, Director of Medicines post-licensing at the MHRA said, "We are advising healthcare professionals that patients should be carefully monitored for signs of depression, suicidal thoughts or suicidal behaviour and referred for alternative treatment if necessary. Children who are doing well on this medication should continue their treatment. Those who experience any unusual symptoms, or are concerned, should speak to their doctor to discuss the best course of action."
Updated warnings will be put on the patient information leaflet (PIL) for Strattera® about the risk of suicidal thoughts and behaviour.
Patients and healthcare professionals are urged to report any suspected adverse reactions to Strattera® via the Yellow Card Scheme. They are
available directly from the Yellow Card hotline on freephone 0808 100 3352 or can be completed on the web at
www.yellowcard.gov.uk.
Ends
Notes to Editor:
1. Strattera® (atomoxetine) is used to help control the symptoms of
attention deficit hyperactivity disorder (ADHD - inability to pay attention and
impulsiveness and hyperactivity) in children and adolescents. It was licensed in the UK in July 2004.
2. It is estimated that approximately 15,000 patients have been
treated with Strattera® in the past year. It is not extensively used in the UK
and Ritalin® (methylphenidate) is the main drug used in the treatment of ADHD.
3. On 15 September 2005, the manufacturer (Lilly) submitted further
analyses of their clinical trial data which do identify an increased risk of
suicidal thoughts in those receiving Strattera® compared with those receiving placebo.
4. The Yellow Card Scheme enables healthcare professionals and
patients to report any suspected adverse drug reaction to the MHRA.
5. The MHRA is the government Agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe. We keep
watch over medicines and devices, and we take any necessary action to
protect the public promptly if there is a problem. No product is risk-free.
Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks."
Suicidal thoughts in children and adolescents treated with
Strattera (atomoxetine)
1. What is Strattera (atomoxetine)?
Strattera (atomoxetine) is used to help control the symptoms of attention deficit hyperactivity disorder (ADHD - inability to pay attention and impulsiveness and hyperactivity) in children and adolescents. Strattera is authorised for the treatment of ADHD in children of 6 years and older and in adolescents as part of a comprehensive treatment programme. Treatment must be initiated by or under the supervision of a physician with appropriate knowledge and experience in treating ADHD.
2. How long has Strattera been on the market?
Strattera has been marketed in the UK since July 2004 but has been available in the United States since November 2002.
3. How many patients are taking Strattera in the UK?
It is estimated that up to 15,000 patients have been treated with Strattera since it was marketed.
4. What is the issue?
An analysis of 12 clinical trials carried out in 1,357 children/adolescents that compared the effects of Strattera and placebo (sugar pills) in the treatment of ADHD has identified an increase in the rate of suicidal thoughts/behaviour in Strattera treated individuals compared with those receiving placebo.
There were six events occurred in those treated with Strattera - one
case of suicide attempt and five of suicidal thoughts.
No events occurred in 851 patients receiving placebo.
The age range of children experiencing these events was seven to 12 years. It should be noted however that the number of adolescent patients included in the clinical trials was low. There were no completed suicides in these
trials.
5. What advice is being given?
The Chairman of the Committee on Safety of Medicines (CSM) is writing to health professionals to advise that:
• Patients on Strattera should be monitored for signs of depression,
suicidal thoughts or suicidal behaviour and referred for appropriate treatment if necessary.
• Patients and parents should be informed about this risk and advised to watch for any clinical worsening, irritability or agitation, suicidal thoughts or behaviour or other unusual changes in behaviour. Children taking Strattera who are feeling well need not be concerned. Those who are concerned or unwell should consult their doctor to discuss the best course of action.
6. Are there alternatives to taking Strattera?
Methylphenidate (trade names are Ritalin, Concerta XL and Equasym) is an
amphetamine like drug
which has been available in the UK for decades and was licensed as part of a comprehensive treatment programme for attention deficit hyperactivity disorders (ADHD) in children aged 6 years and older in 1988. Treatment should be under the supervision of a specialist in childhood behavioural disorders.
7. Do these alternative treatments carry the same risk?
It is recognised that methylphenidate (trade names are Ritalin,
Concerta XL and Equasym), another medicine licensed for the treatment of ADHD, may worsen an individual's underlying depression.
MHRA
29 September 2005"
END OF TRANSCRIPT
Amphetamine/Speed-like substance - licensed for children of 6 years old by government drug regulators!
SAY NO TO REGULATORS, DOCTORS, and STREET PUSHERS! SAY NO TO CHILDREN ON SPEED!
Children who are doing well on this medication should continue their treatment 