Risperdal and Invega are antipsychotic medications made by Janssen Pharmaceuticals, a division of Johnson & Johnson. As second-generation antipsychotics they are supposed to be safer and more effective at treating certain conditions like schizophrenia. Risperdal is the older of the two, first approved by the U.S. Food and Drug Administration (FDA) in 1996, Invega in 2003.
Although Janssen and Johnson & Johnson have made billions on these medications, some patients have suffered serious complications from using them. Lawsuits over breast enlargement in young boys and muscle disorders, among other issues have cost the companies money in settlements and have led to calls from the public and advocates to recall the drug. There have been a few smaller Risperdal recalls and Invega recalls for various reasons, but in spite of the dangers associated with them, no full recall has ever been issued by the FDA or voluntarily by Johnson & Johnson
Risperdal and Invega: Second-Generation Antipsychotics
Risperdal is the generic drug risperidone and Invega is known as paliperidone. Both were developed by Janssen and were approved by the FDA to treat schizophrenia in adults. They can also be used to treat children over the age of 13, but they are not recommended for use in children. Both antipsychotics may also be used to treat mania during bipolar disorder cycles, and Risperdal can be used in children on the autism spectrum who display aggressive behaviors and severe mood swings.
Off-label, some doctors may prescribe Risperdal for attention deficit hyperactivity disorder, ADHD. This use has been controversial and has led to some of the lawsuits over the drug. Risperdal may be effective in treating some of the symptoms of ADHD like impulsiveness, inattention, and hyperactivity, but it can cause some serious side effects too.
There have been two Risperdal recalls and one Invega recall, all three over manufacturing or packaging mistakes that led to damage or contamination of the drugs. In 2011, certain lots of Risperdal were recalled because of contamination with a chemical called TBA. This is a chemical used in the treatment of wood, often in construction pallets. It is not necessarily toxic, but it does give off an offensive odor that may cause some people gastrointestinal distress. It was enough of a problem to initiate a recall of the affected lots of Risperdal.
In 2013 Risperdal faced another recall, this time because of contamination from mold. Luckily only one lot of the medication was affected because mold can be dangerous. The recall was voluntarily undertaken after testing found mold contaminants in a lot of over 70,000 dosages. As reported by Johnson & Johnson, no patients were harmed by the mold, but that may have been a lucky miss. If they had not recalled the lot, some people sensitive to the mold may have had serious reactions to it.
The Invega recall occurred in 2011. It was related to the syringes used to dose the injectable form of the drug. About 70,000 syringes were found to be possibly cracked. Cracks in the syringes could cause infections or reduced effectiveness of the drug. The recalled products were supposed to be sold around the world. Each of these recall incidents were indicative of manufacturing problems that Johnson & Johnson has had that put patients at risk.
Problems with Risperdal and Invega May Lead to Wider Recalls
So far all recalls associated with Risperdal and Invega have been associated with manufacturing problems, but there are serious health concerns too. These have spurred numerous lawsuits and eventually may lead to wider recalls of the drugs if evidence mounts and shows that they are riskier than the benefits to patients warrant. For many patients the benefits of using Risperdal or Invega are worth the potential risks, but for some those risks can be life-changing or may even be fatal. The FDA must weigh these risks and decide if a recall is necessary.
One of the most troubling problems has affected young boys taking Risperdal. With the increase in use of the drug off-label for boys with ADHD, this issue has become more widespread. Some boys have experienced gynecomastia while taking Risperdal, or breast enlargement. There is no real medical or health concern associated with gynecomastia, but it can be emotionally and psychologically damaging for a young boy to have breasts.
Most patients who experienced this side effect had to have surgery to remove the excess breast tissue, which comes with its own health risks. Most of the lawsuits related to Risperdal have come from the families of young boys who faced this problem. Plaintiffs have accused Johnson & Johnson of promoting the drug off-label for use in children, which is illegal and may have led to more boys being put at risk of developing gynecomastia.
Another serious issue with both Risperdal and Invega is the risk of death in certain elderly patients who take them. The drugs carry a black box warning about the fact that elderly people with symptoms of dementia using them may lead to death. The warning was only added in 2006 decades after Risperdal was on the market and years after Invega came out. The FDA required the warning after analyzing several trials that showed this specific population was more likely to die while taking either Risperdal or Invega as compared to those not taking either drug.
If you or someone you care about took Risperdal or Invega and were harmed by it, you are probably angry and looking for answers. From the death of an elderly patient to the devastating breast growth in a young boy, the health complications of these two drugs have the potential to be serious.
Recalls have not been issued over these health problems, but a number of lawsuits have been settled and filed. If you believe that Johnson & Johnson was guilty of wrongdoing in what you suffered from taking either drug, you may have a case to make against the company. Let a lawyer help you decide if you do have a strong case and what you can do to move forward.