Risperdal, Atypical Antipsychotic, Linked to Fractures in Seniors

Toronto, CanadaA new study by researchers in Canada suggests that atypical antipsychotic medications such as Risperdal may have side effects that include a risk of falling and a risk of fractures. The study, which was published online in JAMA Internal Medicine (1/12/15) found that seniors aged 65 and older who were newly taking atypical antipsychotic medications were at an increased risk of falling and/or suffering fractures compared with patients not newly taking atypical antipsychotic medications.

Risperdal is an antipsychotic medication, used to treat schizophrenia and symptoms of bipolar disorder. It is sometimes prescribed off-label to treat conditions linked to dementia, especially in senior citizens. Other antipsychotic medications include Seroquel (quetiapine) and Zyprexa (olanzapine).

For the study, researchers analyzed data from adults aged 65 and older who were newly prescribed an atypical antipsychotic medication, including risperidone (the generic version of Risperdal). Information was tracked for 90 days following prescription, to identify if patients were treated for a fall or fracture. Researchers found that new prescriptions for atypical antipsychotic medications were associated with a 50 percent increased risk of a serious fall and a 52 percent increased risk of a nonvertebral osteoporotic fracture.

That increased risk was consistent regardless of the specific antipsychotic being prescribed or the dose of medication given.

Risperdal is not approved to treat symptoms of dementia in seniors, but is prescribed off-label for such use. Such off-label use, however, could put seniors at risk of adverse events including falls and fractures. Although it is not illegal for doctors to prescribe medications off-label, it is illegal for drug companies to market their medications for such uses.

According to reports, in 2014, Johnson & Johnson paid more than $1.6 billion in penalties from a settlement announced in November 2013 involving claims of illegal promotion of off-label drug uses. In November 2013, Johnson & Johnson agreed to settle allegations that the company knowingly marketed Risperdal for use in patients with dementia, even though the US Food and Drug Administration had refused to approve it to treat dementia because of an increased risk of stroke in patients using the medication to treat dementia. The Department of Justice also alleged Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, had evidence that Risperdal had an increased risk of diabetes but still marketed the medicine as having no safety concerns.