Risperdal and Invega rained billions of dollars for their manufacturer, Johnson and Johnson’s. Bestsellers perhaps, but these antipsychotic drugs but both are linked to serious adverse effects like abnormal breast development in boys and a difficult-to-treat movement disorder called tardive dyskinesia. Worst, these drugs can even lead to a grievous sudden cardiac arrest. Johnson and Johnson had already paid billions of dollars to legislators for concealing these side effects from the public and now, the manufacturer is facing mounting lawsuits filed by those who were injured by Risperdal and Invega.
In 1993, the Food and Drug Administration (FDA) approved Risperdal for schizophrenia. Invega was approved in 2006 for treating the same condition. Later, FDA expanded the uses of these drugs for treating bipolar disorder in adults and adolescents as well as for a limited class of Austism Spectrum Disorders. It was in 2006 when medical authorities approved Risperdal for children’s usage but long before that, the drug has already been off-label marketed. Risperdal and Invega are marketed under the hood to address other medical problems like anxiety, sleep disorders, depression and Attention Deficit Hyperactivity Disorder (ADHD) in children.
Risperdal used to be Johnson and Johnson’s, and Janssen’s (J & J’s pharmaceutical company) biggest cash cow with sales peaking over $4.5 billion in 2007. It only declined when the company lost the drug’s patent protection. As of 2012, J&J reported that Risperdal was only making a little over $300 million. Invega was also a once-upon-a-time among the bestsellers of the manufacturer with sales raging for as high as $424 million in 2010.
Lawsuits were thrown to Johnson & Johnson for Risperdal and Invega because of two major issues as cited;
1. The off-label marketing uses of these drugs when J&J marketed both medications before FDA’s approval, and,
2. The serious side effects which includes breast enlargement on boys (gynecomastia) which may require surgery and some hard-to-treat movement disorders like tardive dyskenisia
How these Second-Generation Antipsychotics (SGAs) Work
Second-Generation Antipsychotics are believed to have less risk of extra pyramidal adverse effects compared to First-Generation Antipsychotics (FGAs).
Risperdal’s active components, called metabolites, break down in the liver. The broken components work by blocking some receptors in the brain. Invega, on its end, is a metabolite of Risperdal, the most important one. Invega has similar physiological effects like Risperdal although it is metabolized by the body in a different way.
Risperdal and Invega are meant to work on their own, but in some cases, they may be combined with other drugs such as antidepressants. Risperdal are sold in liquid, tablet or injectable forms while Invega have extended-release tablet. It also comes in a-once-in-a-month injectable form branded as Invega Sustenna.
Adverse Effects that Led to Lawsuits
Risperdal and Invega as Second Generation Antipsychotics target two receptors in the brain – serotonin and dopamine – to reduce or cure psychiatric conditions. SGA drugs are generally used as major tranquilizers and/or neuroleptics.
As serotonin/dopamine antagonists, Risperdal and Invega work by blocking those neurotransmitter chemicals in the brain to create balance. Unfortunately, the way these SGA’s work is also the cause why abnormalities occur leading to several physical issues, some that are even fatal.
Serious and Fatal Side Effects of Risperdal and Invega
• Gynecomastia. Gynecomastia is the most reported adverse effect of Risperdal and Invega. The condition refers to the enlargement of the tissues and growth abnormality on a male’s breasts, more specifically to adolescent. The breasts then appear as though they were of a woman’s. This abnormal growth happens because Risperdal and Invega increase prolactin levels in the body. In a few reported cases of those who experienced Risperdal gynecomastia, milky-like discharge was also noted.
• Movement Disorders. Among the most dangerous adverse effects of SGAs like Risperdal and Invega are movement disorders like tardive dyskinesia, dystonia and Extrapyramidal Symptoms (EPS). Some of these disorders are treatable but severe cases often become permanent conditions.
• Diabetes, Heart Problems and Death. Risperdal and Invega are linked to high blood sugar and Type 2 diabetes among patients who have taken them. Antipsychotics like these carry black-box warnings which indicate risk of sudden cardiac arrest.
Other Invega and Risperdal Side Effects:
• Priapism (prolonged penile erection)
• Akathisia (restlessness)
• Abdominal pain
• Nausea Anxiety
Illegal Marketing of Risperdal
Risperdal has been marketed off-label to treat Attention Deficit Hyperactivity Disorder (ADHD) and children and elder medical conditions despite of the fact that it was only approved for a limited autism-related conditions and schizophrenia. Doctors may be allowed to prescribe off-label medications but the law prohibits companies from actively promoting these drugs; something that J&J missed as the manufacturer was accused for extensively marketing Risperdal for off-label uses since the 90’s. Johnson and Johnson’s extensive marketing approaches included giving bonuses to sales companies who marketed the drug to doctors and providing lucrative consulting deals to those doctors who prescribed these drugs. It was also cited J&J paid physicians to give favorable speeches for Risperdal.
Government regulators, the District of Columba and attorneys general of 36 states settled a lawsuit with Johnson & Johnson on August 2012. There had been a negotiation between J&J and the federal authorities and on 2013, the company finally paid $2.2 billion to settle those charges.
Since Respirdal’s birth in the market, it was already consumed by countless of children, young adults and elder-lies.
On September 2012, Aaron Banks, a Risperdal consumer who widely used the drug from the years 2000 to 2004, settled a lawsuit over Johnson and Johnson. His unpleasant experienced with the adverse effect of the drug included psychological trauma and humiliation brought by breast enlargement which he got as a side effect from taking the drug. Banks had to undergo to a surgery to treat the condition. It was the success of the Aaron Bank’s lawsuit that leads hundreds of other Risperdal consumers to step forward and file cases against J&J.
Lawsuits, Recalls and Settlements Timeline
Stepping back to the early 1990’s, Johnson and Johnson had already asked the Food and Drugs Administration to approve Risperdal for children and young adults but FDA denied the request. FDA analyzed that there wasn’t sufficient evidence to prove the efficacy of the drug; hence, the denial of J&J’s request.
On January 2010, the Department of Justice, state attorneys general and whistle blowers filed lawsuit against J&J stating that the company paid millions of dollars to a pharmaceutical supply company to backed some bogus services. A year later, in August 2011, several states filed lawsuits against Johnson and Johnson for off-label promotions of Risperdal without disclosing the possible severe adverse effects to its consumers
• 2011. Two lots of Risperdal were re-called due to chemical contamination.
• February 2011. 70 000 syringes of Invega Sustenna were discovered to have cracked that could lead to reduced efficacy, worse, infections to its users.
• 2013. A lot of Risperdal Consta injectable was re-called due to mold concerns.