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The findings of new research suggest that more than half of patients in the U.K. prescribed powerful antipsychotics like Risperdal, Seroquel and Zyprexa appear to be given the drugs for off-label uses, which have not been determined to be safe and effective.
In a study published last month in the British Medical Journal, researchers from the University College of London found that large numbers of patients prescribed both first generation and newer antipsychotics were given the drugs for reasons other than those approved by government regulatory agencies. In some cases, only a fraction of the patients given the drugs had bipolar disorder, psychosis, depression or other ailments for which the drugs are approved.
Researchers looked at data on more than 47,000 patients prescribed either the newer drugs Risperdal, Seroquel or Zyprexa, or older first generation antipsychotics such as Haldol or chlorpromazine, examining the causes of the prescriptions and psychological disorders diagnosed among the patients.
Off-label use occurs when a drug is prescribed for a purpose that is not approved by government drug regulators, such as the FDA in the U.S. While doctors in the U.S. are free to prescribe the drugs for any reason they see fit, drug manufacturers are not allowed to advertise the drugs for such uses, until they have provided evidence establishing that the indication is safe and effective.
Less than 50% of those prescribed Haldol or chloropromazine were diagnosed with either a psychosis or bipolar disorder, the researchers determined, meaning more than half were prescribed the drugs for off-label uses.
Rates of off-label prescriptions for the newer drugs were often even higher. Only 46% of Risperdal prescriptions in the U.K. were for approved uses, while an even lower number, 36%, were prescribed Seroquel for uses approved on the label. Zyprexa had the highest percentage of prescriptions actually approved by regulators at 62%.
Researchers found that those prescribed the drugs for off-label uses were often given the highest doses, increasing the risk of side effects from Risperdal and other antipsychotics.
In some cases, the drugs were prescribed for uses like dementia, which medical professionals have specifically warned against. Antipsychotics prescribed for dementia increase the risk of death, provide few if any benefits and are often used as a form of chemical restraint in nursing homes, the FDA and other medical groups have warned.
The study also comes amid increasing concern over the side effects of Risperdal, particularly when prescribed to boys and young men. Researchers in the latest study found that in the U.K., Risperdal was the antipsychotic most often prescribed to patients under the age of 18, often for uses that have not been approved.
Risperdal (risperidone) is an atypical antipsychotic medication originally introduced for adults with schizophrenia. However, the medication has been widely used among children for behavioral disorders as well, including schizophrenia, bi-polar disorder, autism and aggression.
Use of Risperdal by young boys has been linked to a risk of gynecomastia, which is a rare medical disorder where the males develop full breasts. Some boys and young men using Risperdal have experienced the development of breasts up to a D-cup, often resulting in the need for surgical removal.
In the United States, a growing number of Risperdal lawsuits are currently being pursued against the drug makers, alleging that inadequate warnings about the gynecomastia risk were provided for families and the medical community. In addition to the physical injury, the complaints often allege that the young boys who experienced breast growth face humiliation, bullying and other psychological problems as a result of Risperdal-induced gynecomastia.