Prescribing Information for Risperdal and Invega Doesn't Protect Patients

Johnson & Johnson is currently in the midst of reaching a settlement agreement with the Department of Justice for illegally marketing its anti-psychotic drug Risperdal to adolescents at a time when the drug only had Food and Drug Administration (FDA) approval for use in adults. As the government and the drug giant struggle to come to terms with each other, advocates for Risperdal victims and their families continue to fight J&J to update the medication's prescribing information to keep patients safe.

Risperdal and Invega, both manufactured by Johnson & Johnson, are strong medications intended for the treatment of serious psychiatric disorders like schizophrenia. While the medications can be effective, when taken by adolescents, especially males, they can have devastating side effects such as breast development and even milk production.

Currently, a citizens group representing individuals that have been injured by these drugs is seeking to have the FDA revoke approval for their use in children and adolescents. Their petition is backed by the medical guidance of Dr. Mark E. Mollitch, an endocrinologist and former member of the FDA's metabolic/endocrine Advisory Committee.

In his article Drugs and Prolactin, Mollitch notes that Risperal causes higher prolactin elevations than other anti-psychotic drugs in its class (prolactin elevation can lead to many complications including menstrual disruption in females, and erectile dysfunction and breast development in males.) In discussing this serious problem, Mollitch notes that the best way to diagnose medication-induced hyperprolactinemia is to "take the patient off the medication" and see if prolactin levels return to normal.

Not surprisingly, J&J has not provided doctors with that recommendation for the treatment of elevated prolcatin levels in patients taking Risperdal and Invega. If they did tell doctors that this was the best way to keep their young patients from developing devastating side effects, the drug giant's bottom line would be greatly reduced.

How bad would it be for J&J to share this prescribing recommendation with doctors? According to the company's own prescribing information, "87% of children and adolescents experienced elevated prolactin levels" while on Risperdal or Invega. If the company told doctors that children should stop taking the medication in order to correct hyperprolactinemia, they would lose almost all of their youngest consumers!

Since J&J has refused to do the right thing and stop these dangerous medications from being prescribed to children, the drug injury attorneys at Arnold & Itkin support the petition to the FDA to revoke Risperal and Invega's approval for use in children and adolescents. We believe it is the only way to preserve public safety.


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