If your child has suffered physical, emotional, or social damage from taking the drug Risperdal, please contact the attorneys at Raizner Slania LLP.
What Is Risperdal?
Risperdal is an atypical antipsychotic drug manufactured by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. It is used to treat bipolar disorder and schizophrenia in adults and adolescents ages 10-17. Originally approved by the FDA for use in adults with schizophrenia in 1993, Risperdal affects the levels of dopamine and serotonin in the brain, neurotransmitters known to impact mood and behavior. Risperdal is also known as Risperdaloro, Risperidona, Risperidone, and Rispolept.
Risks and Warnings
Risperdal generated worldwide sales of $24.2 billion from 2003 to 2010, despite the following risks and warnings:
In April 2005, the FDA issued a black box warning about antipsychotics, including Risperdal, stating that use of the drugs increased the risk of death in elderly dementia patients.
In 2006, Risperdal was approved to treat irritability in children with autism, but later that same year, researchers at Duke University found that the risk of gynecomastia, or male breast growth, was higher with Risperdal than with other antipsychotics, concluding that it accounted for 70 percent of the gynecomastia cases studied.
In spite of earlier findings, in August 2007 the FDA approved Risperdal for the treatment of acute mania or mixed episodes associated with Bipolar 1 disorder in children and adolescents.
In November 2008, The Wall Street Journal reported that Risperdal use was linked to the increased production of prolactin, a hormone that stimulates breast development and milk production in women. In women, excess prolactin levels can cause spontaneous milk production; in men, excess levels of prolactin can lead to gynecomastia, the abnormal growth of male breast tissue. In addition to breast growth, increased levels of prolactin may also increase the risk of breast cancer in young boys and adolescents, and damage the male reproductive system.
There have been nearly 13,000 adverse reactions reported to the FDA in connection with Risperdal, and the FDA estimates that less than 1 percent of all serious events are ever reported, indicating that the actual number of side effects occurring is likely much higher.
Hundreds of victims have filed claims over the more serious Risperdal side effects, and Johnson & Johnson has already paid several large settlements.
Risperdal and Gynecomastia
Although gynecomastia does not cause severe health complications, its effects are physically, psychologically, and emotionally damaging, particularly to adolescent male patients.
The symptoms of gynecomastia include:
- Breast pain
- Nipple discharge in one or both breasts
Surgery is often required to correct the condition, although liposuction can be effective in removing excess breast tissue in mild to moderate cases. In more severe cases, patients may need a mastectomy to remove breast tissue and excess breast skin.
Risperdal Lawsuit Information
It has been reported that among the 420 Risperdal lawsuits pending against Johnson & Johnson and its Janssen subsidiary, at least 130 of these cases allege that the drug caused male adolescent patients to grow breasts, suffer psychological trauma, and in many cases required surgery to remove the breast tissue.
Allegations of illegal marketing activities between 1993 and 2004 eventually caught the attention of consumer protection regulators in 36 states, and in August 2012, the makers of Risperdal reached an agreement with those states to settle numerous claims of misconduct for $181 million. Johnson & Johnson has also paid a reported $2.2 billion to settle federal charges of improper marketing and kickbacks associated with promoting a number of drugs for off-label use, including Risperdal. The drug maker is also accused of providing monetary incentives to Omnicare, a pharmaceutical supply company, to persuade doctors to prescribe Risperdal to patients.
If someone in your family has experienced physical and emotional trauma from taking Risperdal, please contact the attorneys at Raizner Slania LLP online for a no-risk consultation today.