Made For Adults, Used On Children
When a drug is prescribed to your child, you assume that it has been approved for children by the U.S. Food and Drug Administration (FDA). Sometimes, though, this is not the case. The antipsychotic drug Risperdal is one of those drugs that is regularly prescribed to children, but has not actually been approved by the FDA for use by children, other than in cases of bipolar disorder and schizophrenia. Manufactured by Johnson & Johnson, Risperdal first got FDA approval in 1993 to treat bipolar disorder and schizophrenia in adult patients.
Recently, a trend with Risperdal is for the drug to be used "off-label." Off-label prescribing is permissible if a doctor believes that a medicine may benefit a patient. However, the manufacturer is not allowed to promote a medication for an off-label purpose. Yet, this is just what Johnson & Johnson did. For example, at a Risperdal trial in Pennsylvania, a manager claimed that Johnson & Johnson trained salespeople to promote Risperdal to children's doctors. Additionally, according to Drug Dangers, investigations have revealed a 1994 Risperdal product plan that discussed "seeding" of promotional material with underlying suggestions that the product could be used in children and for unapproved uses. The company has also been accused of other improper marketing practices promoting unapproved uses such as the widespread use of:
- Physician motivational tools such as speaker fees, free travel and retreats, consulting agreements and other incentives to "learn" about unapproved uses for Risperdal
- Monetary incentives and sales motivational goals for pharmaceutical representatives to promote unapproved uses in children with behavioral issues
- Provision of large quantities of free samples to physicians known to be using the medication for unapproved uses
Find Out About Your Legal Options
If you have suffered from side effects after taking Risperdal, you may be entitled to compensation for your medical expenses, pain and suffering, and emotional distress. For more information about your legal options or to schedule a free and confidential attorney consultation, call 713-352-7883 or 877-643-3099 toll free or complete our contact form.