FDA Approved Uses of Risperdal
Risperdal has been approved by the FDA to treat certain psychological disorders. It is used to treat various disorders in adults and children, such as schizophrenia, bipolar disorder, and complications from autism. There has even been a push to treat Attention Deficit Disorder with it.
If a person has taken Risperdal, one of the biggest dangers they could face is gynecomastia or the development of male breast tissue. If you or a loved one were prescribed Risperdal for a mental disorder and are now struggling with gynecomastia, a Raleigh Risperdal lawyer can help.
Some of the disorders Risperdal is approved by the FDA to treat include schizophrenia, bipolar disorder, and complications from autism. Additionally, there are some off-label uses of Risperdal to treat Attention Deficit Hyper Activity Disorder or ADHD. The symptoms of the underlying illness may include severe mood swings, major depressive disorder, and a withdrawal from activities and other people. If a person is noticing any of these in a loved one, it would be worth talking to a family doctor.
There may be other side effects of Risperdal, however, the one that is most concerning is gynecomastia, or the development of male breast tissue. Gynecomastia is not necessarily just weight gain, but there may be other associated symptoms with the breast tissue growth. This can have some devastating effects on those affected, especially if they are young men.
In 1993, the FDA first approved Risperdal for the use in the management of manifestation of psychotic disorders. In 2003, the FDA approved Janssen Pharmaceuticals’ request for additional usage of Risperdal for adult’s short-term treatment of acute manic or mix episodes associated with bipolar disorder as well as for those with schizophrenia. In 2006 and 2007, the FDA approved Risperdal use for children and adolescents for the treatment of bipolar, schizophrenia, and autism disorders.
As more and more adverse event reports were filed, these dangers became more recognized. For example, the first instance of gynecomastia was indicated as a low risk, rare event, and was not highlighted in the warning label. After additional clinical trials and the adverse reports, the warning labels were changed to warn of the increased risk of gynecomastia.
FDA Warnings Issued
In 2006, it started to be well-known by the FDA that Risperdal could cause gynecomastia. These warnings are important because they indicated that the pharmaceutical company, Janssen Pharmaceuticals of Johnson & Johnson, had actual or constructive knowledge of the dangers associated with their medication.
The thinking is that the company either had knowledge that Risperdal could cause gynecomastia or that they should have known and did not perform enough testing of their product before it was rushed to market. The claim brought against Jannsen Pharmaceuticals is a failure to warn claim, alleging that they knew or should have known about the increased risk of gynecomastia and failed to disclose it through clinical trials or information submitted to the FDA. They failed to warn the public and prospective patients about the risk associated with taking Risperdal.