Risperdal and Other Antipsychotics Prescribed for Unapproved Indications

Dr. Sharon Orrange
Dr. Orrange is an Associate Professor of Clinical Medicine in the Division of Geriatric, Hospitalist and General Internal Medicine at the Keck School of Medicine of USC.
Posted on

Three to four years ago those of us in primary care started to see more and more of our adult and elderly patients on Risperdal (risperidone) for many different uses. As it turns out, the drug company making that drug, Johnson and Johnson, will now be paying $158 million to settle claims that it inappropriately marketed Risperdal for non-FDA-approved uses. They aren’t the only ones; several other antipsychotic drug makers are paying big bucks for doing the same thing, specifically for Geodon and Zyprexa.

So how did we get so many prescribers to drink the Kool-Aid and prescribe Risperdal for off-label use? Marketing. Which is why at many academic centers, including mine, pharmaceutical reps are no longer allowed in hospitals, nor are any items with drug names on them (pens, pads, lights, thumb drives).

Risperdal is a member of a class of drugs known as atypical antipsychotics (Seroquel and Zyprexa are two others). Risperdal is approved and works well for the treatment of schizophrenia, bipolar disorder, and irritability associated with autism. Those are the three FDA-approved indications for risperidone. Period.

Many risperidone prescriptions are written for non-FDA-approved indications, also known as “off-label use”. Some others include behavioral disturbances (agitation and aggression) in adults with dementia, the treatment of tics associated with Tourette’s syndrome, severe behavior disorders associated with Tourette’s or attention-deficit hyperactivity disorder (ADHD), severely disruptive behaviors in children with developmental disability, and psychotic depression in adults.

The problem here is that physicians are taking a leap of faith and prescribing a drug for non- approved use based on information (“marketing”) from the company making the drug. You can see the danger there, I’m sure. Off-label use of atypical antipsychotics like risperidone is associated with benefits yes . . . but also harms.

For the downside, a Rand study this year found that off-label use of atypical antipsychotics was associated with several types of adverse events in older adults. These events included death, stroke, urinary tract symptoms, and weight gain.

Weigh in.

Dr O.

Risperdal is typically considered a Tier 3 drug by insurance companies if it is covered, meaning that you would pay your highest copay. The generic equivalent, risperidone, is usually considered a Tier 1 drug, falling under the lowest copay. Risperdal runs from about $150 for 30 0.25mg tablets to around $400 – $500 for 30 4mg tablets. Risperidone, in contrast, can be as much as $100 for 30 tablets, while some strengths are included in reduced price generic programs and may be as little as $4 for 30 tablets.

Drugs featured in this story

Filed under