January 7, 2011
Researchers in a new study have found that doctors write millions of prescriptions of antipsychotic medications for off label uses every year despite a lack of evidence of benefit for these uses and risk of serious side effects.
Physicians are prescribing the newer antipsychotic drugs known as second generation or atypical antipsychotics (AAP), developed since the 1990’s for treatment of schizophrenia, for off label uses such as bipolar disorder, depression, anxiety, attention deficit disorder, dementia and autism.
Since 1995, the number of prescriptions written for these drugs has doubled, reports Reuters.
More than half of the 16.7 million prescriptions written for these drugs in 2008 were for off label uses. Off label use is the prescribing of a drug for treatment of a disease or condition that the U.S. Food and Drug Administration (FDA) has not approved.
“Atypical agents were once thought to be safer and possibly more effective,” Dr. G. Caleb Alexander, lead researcher on the study, told WebMD. “And what we’ve learned over time is that they are not safer, and in the settings where there’s the best scientific evidence, they are no more effective.”
In prescribing these drugs for off label uses, physicians are placing patients at risk for serious and potentially fatal side effects without evidence the drugs even work. Patients taking typical antipsychotics can have adverse effects such as weight gain, diabetes, heart disease, hyperlipidemia and sudden death.
Atypical antipsychotics include:
- Aripiprazole (marketed as Abilify)
- Clozapine (marketed as Clozaril)
- Olanzapine (marketed as Zyprexa)
- Olanzapine/Fluoxetine (marketed as Symbyax)
- Quetiapine (marketed as Seroquel)
- Risperidone (marketed as Risperdal)
- Ziprasidone (marketed as Geodon)
The study entitled Increasing off-label use of antipsychotic medications in the United States, 1995–2008 appears in this month’s issue of Pharmacoepidemiology & Drug Safety.
“Time and time again what we see is medications that are prematurely adopted in populations that have little or nothing to gain, and this study is yet another example of how both doctors and patients may overenthusiastically or prematurely adopt medicines beyond the evidence base,” said Dr. G. Caleb Alexander to WebMD.