Johnson & Johnson unit Janssen Pharmaceuticals agreed to pay $5.9 million to settle a lawsuit brought by Montana’s attorney general alleging the company downplayed or hid Risperdal side effects while marketing the bipolar drug to doctors.
“This settlement is not only significant in terms of the amount of money Montana will receive, but also in that it protects our citizens from being prescribed Risperdal based on the types of false statements Janssen previously made to our health care providers,” Attorney General Tim Fox said in a statement issued by his office.
Janssen is admitting no wrongdoing. However just four months ago Johnson & Johnson agreed to pay $2.2 billion to settle False Claims lawsuits alleging that it paid kickbacks to doctors and promoted unapproved uses for three of its drugs, including Risperdal.
Risperidal, known generically as risperidone, is an antipsychotic medication that is approved by the Food and Drug Administration (FDA) to treat adults and children with schizophrenia, bipolar disorder, and autism with irritability. The drug has also been prescribed off-label for conditions such as anxiety, dementia, and attention deficit hyperactivity disorder, or ADHD.
Doctors have the authority to prescribe drugs to treat conditions for which they are not approved. However, drug companies cannot legally market drugs for unapproved uses. Drug companies are also required to disclose information about side effects associated with the drugs they promote.
Risperidal side effects include high blood sugar and weight gain, which can increase the risk for type 2 diabetes. In some cases, patients using Risperdal have developed extremely high blood sugar levels that led to coma or death. The drug has also been linked to a movement disorder known as tardive dyskinesia and the life threatening neurological disorder, neuroleptic malignant syndrome.
Risperidal can also increase prolactin levels in the blood, a hormone responsible for milk production in postpartum women. This can cause an alarming side effect in boys and young men known as gynecomastia, a condition in which breast tissue develops. Symptoms include tender and painful breasts, nipple discharge, and the growth of female breasts, which can be embarrassing to boys, causing psychological and emotional trauma. It also puts them at greater risk for breast cancer and problems with their reproductive system.
Gynecomastia can last for years. Treatment usually involves the breast cancer drug tamoxifen, or surgical procedures such as liposuction or a mastectomy.