Risperdal, the brand name of the atypical antipsychotic medication risperidone is produced by Janssen Pharmaceuticals, a division of Johnson & Johnson which is the world’s largest pharmaceutical and medical products manufacturer.
Over its lifetime, Risperdal has earned nearly $40 billion in sales for Johnson & Johnson. Brand name Risperdal, which is now available as a generic medication and a similar drug, Invega (paloperidone) continue to bring over $3 billion in yearly earnings for Johnson and Johnson.
Risperdal was approved by the Food and Drug Administration (FDA) in 1993 for the treatment of schizophrenia in adults. It was later approved to treat bipolar disorder and by 2007, three pediatric indications were added including schizophrenia in children, bipolar disorder in adolescents and behavioral disorders associated with autism.
Johnson & Johnson and its subsidiary, Janssen face multiple accusations and lawsuits claiming improper marketing of the medication for children prior to its approval for use in any children, dating back to 1994.
Off-Label Prescribing of Risperdal
Off-label prescribing is allowed for uses that are not approved by the FDA if a physician feels that a medication may help a particular patient, however the manufacturer is prohibited from promoting the medication for any unapproved indications.
Johnson & Johnson and the subsidiary Janssen, requested approval for the use of Risperdal in children shortly after the medication was first approved in 1993. The FDA rejected the pediatric application in 1996 due to a lack of clinical evidence. Despite the lack of approval, reports have surfaced indicated that Janssen had been illegally marketing Risperdal for use in pediatric patients since the product first came on the market.
Janssen also has been accused of marketing the medication for other unapproved uses such as general autism, ADHD, depression, obsessive-compulsive disorder, anxiety, conduct disorder, post-traumatic stress disorder, and uses in the elderly such as Alzheimer’s disease.
At its peak revenue year of 2007, just prior to generic approval, Risperdal garnered over 50 percent of the market for antipsychotic use in both children and elderly patients.
Specific Marketing Activity
Janssen’s application for Risperdal use in children had been denied by the FDA in 1996 due to a lack of evidence for safety and effectiveness and a failure to specifically identify disease states for which it would be used. FDA documentation dating back to this time shows that the FDA noted suspicions that the approval had been requested because the medication was already in use in adolescents and children.
Investigations have revealed a 1994 Risperdal product plan that discussed “seeding” of promotional material with underlying suggestions that the product could be used in children and for unapproved uses. The company has also been accused of other improper marketing practices promoting unapproved uses such the widespread use of:
- Physician motivational “tools” such as speaker fees, free travel and retreats, consulting agreements and other incentives to “learn” about unapproved uses for Risperdal
- Monetary incentives and sales motivational goals for pharmaceutical representatives to promote unapproved uses in children with behavioral issues and in elderly patients with dementia
- Provision of large quantities of free samples to physicians known to be using the medication for unapproved uses
- Volume based kickbacks paid to the largest pharmacy provider for nursing homes
Some of these practices led to government insurance fraud in programs such as Medicaid and Medicare for which the company paid $172 million in civil penalties and $485 million in criminal penalties to the US government and 45 states.
Child Specific Risks Associated with Risperdal
Risperdal was not approved for any uses in children until 2006 but clear problems had surfaced at least 5 years prior when the Miami Herald reported severe side effects being suffered by children in the foster care system when Risperdal had been used as a chemical restraint, also an unapproved use.
At least 1,207 serious adverse events including 31 deaths were associated with Risperdal use in children between 1993 and 2008. Multiple studies and reports have continued to confirm serious risks associated with Risperdal use in children.
Risperdal has been shown to cause gynecomastia or development of breast tissue in males, due to a stimulation of the pituitary gland, resulting in increased levels of prolactin, a hormone common in pregnant and nursing women.
The development of gynecomastia is particularly disturbing in adolescents and children as in addition to the physical changes which are permanent and must be removed through surgery, boys will often suffer significant emotional and mental trauma.
Risperdal has also been shown to cause premature development of breasts in girls and to cause lactation in women who are not pregnant or nursing (galactorrhea) and may cause the development of pituitary tumors which create multiple metabolic disruptions.
Other Risks of Risperdal:
- Risperdal may also cause severe and life-threatening reactions in both children and adults such as:
- Tardive Dyskinesia –movement disorder causing abnormal facial and limb movements which must be treated with additional medication and is often irreversible even when the drug is discontinued
- Neuroleptic Malignant Syndrome – serious reaction causing muscle rigidity, uncontrollable fever, changes in consciousness that may be life-threatening
- Other Movement Disorders– tremors, agitation, sedation, blurry vision, dizziness, cardiovascular events such as heart failure and metabolic disorders such as diabetes
- Other Severe Risks – metabolic disorders such as diabetes and cardiovascular events such as heart failure and stroke, possibly resulting in death
The first lawsuit regarding Risperdal side effects caused by use in children was filed in 2010 by a 21 year old man who had taken Risperdal for off-label use while a juvenile between 1999 and 2004. He claimed injury suffered from breast tissue development and related emotional trauma.
The company has paid $ millions in settlements regarding injury and trauma associated with Risperdal use and continues to face multiple lawsuits, including those related to improper marketing.