Risperidone Risks For Vulnerable Children In The UK

Risperidone is a second-generation antipsychotic drug (S.G.A.) which was approved for use in both America and the U.K. in 1993 to treat symptoms of serious aggression in adults during psychotic episodes. and then for adult bipolar disorder in 2003.

Doctors have also used the drug for many conditions across the age range in an 'off label'(U.S.) or 'off licence'(U.K.) way.

It was later approved for the short-term treatment of aggression in childhood autism in 2006, above the age of five, under 'expert supervision,' which means in practice a specialist child psychiatrist.

It can only be prescribed for a maximum of six weeks for the treatment of persistent aggression in adults for the above conditions and yet it can be used with many vulnerable children for drug treatments for many years.

This is a cause of great concern to educational and child psychologists across the U.K.

It is regularly reported that risperidone is being used with children whose primary presenting problem is anxiety associated with an autistic spectrum diagnosis. This is worrying as these children do not commonly display prolonged aggression with such a condition.

The NICE website list of 'common or very common side effects' for risperidone is very alarming in relation to the population of children with whom we work. A sample includes:

• agitation/anxiety

• arrythmias of the heart,

• gynaecosmastia (breast development)

• hyperglycaemia (leading to diabetes)

• hyperprolactinaemia (high prolactin levels)

• hypertension

• insomnia

• movement disorders e.g. tardive dyskenesia & Parkinsonisms

• QT interval prolongation which can lead to heart failure

• significant weight gain (from 7.5 kg to 10 kg in twelve months in some reputable studies)

Risperidone has been the subject of two landmark legal rulings and many thousands more individual or class actions in America, which highlights the rationale behind our concerns about its appropriate use in the U.K.

The first in 2013 was a settlement against the drug's manufacturer Janssen, a subsidiary of the Johnson & Johnson Corporation, for $2.3 billion due to violations regarding their publicity in two populations, the elderly and children.

The second was in November 2019 and consisted of one of the largest 'punitive settlements' in U.S. legal history.

The judge and jury chose to impose a fine of $8 billion as the manufacturer had not made the probability of these potential serious side effects in children clear to the public / parents in their advertising literature (this was then reduced to $6.8 million).

After the first trial the U.S. Department of Justice took the unprecedented action of putting out a statement from their director to publicly explain the reasons for the ruling.

There was also evidence in this case that Janssen had organized special sales units to illegally target doctors who treated the elderly and children, whose drugs were paid for by government funded Medicaid (who seem to readily accept grounds for funding such profitable drugs to treat children).

The severe side effects listed above have now been redefined as Metabolic Syndrome (MetS) and there is a developing body of research on this traumatising cluster of adverse reactions.

The particular side-effect of gynaecomastia, which can include eventual lactation, in adolescent boys is our gravest concern regarding any psychiatric medication for children, and is caused by risperidone producing an excess release of the female hormone prolactin in some subjects.

We believe that the resulting psychological trauma is profound at an already emotionally turbulent time of stress in their lives, i.e. adolescence, which is recognised to be a time of confusion and self doubt in young men, often leading to heightened mental distress.

Colleagues in various parts of the country have reported significant numbers of young males showing this severe side-effect, which may be lower than the reality due to the wholly inadequate voluntary reporting system which does not capture all the cases.

We are alarmed that children can be left on these very strong psychiatric drugs for years and are often not being properly monitored, despite the side effects listed above, due to reported shortages of psychiatrist colleagues.

Most local health care trusts (HCTs) rely on the medical health research association's (MHRA) voluntary 'yellow card system' for ensuring cases are reported and for drug safety in all populations and work closely with the national institute for clinical health and excellence (NICE).

We have spoken to pharmacists in our localities and have to conclude that they and the children's parents are not triggering this non-mandatory, yet essential, safeguarding procedure. This, we feel, puts the children we are professionally supporting at a greater risk of harm.

The side effects that young people and their parents are acutely aware of have not been commonly reported due to this procedure not being 'fit for purpose' and we believe there is significant under-reporting of the side-effects which fails to capture the essential monitoring data that services need.

For example, excessive weight gain may not be recorded as a severe side effect but be classified as clinical obesity, thus missing out vital data.

We believe that any reporting system to safeguard children should be supervised by the appropriate professional bodies and be enforced with disciplinary consequences, if it is not followed.

NICE advises that a comprehensive treatment plan should include psycho-social and educational interventions prior to using these medications.

We are sad to say from reports received from professionals in the field that this is rarely happening, possibly due to limitations in the numbers of appropriate personnel.

We believe therefore that the widespread use of risperidone in the vulnerable child population in the U.K. is a major safeguarding Issue which needs addressing and that in some shared cases it can be demonstrated that more physical and psychological harm has been done compared to any benefits for the child by the use of such medications.