The world’s eighth largest drug manufacturer, Johnson & Johnson, agreed to pay as much as $2.2 billion earlier this month to settle US probes into the marketing of antipsychotic drugs – including Risperdal – to older adults, children and the disabled. According to a New York Times article The Justice Department has determined that the company promoted psychiatric medications for uses not approved by the Food and Drug Administration and may have even offered incentives for physicians to frequently prescribe them.
This latest lawsuit kindles concerns
that antipsychotics are being widely and
improperly prescribed to millions of Americans each year.
The American Chemical Society, based in Washington DC published that Antipsychotic drugs like Risperdal work by blocking dopamine, the chemical in the brain that contributes to high risk behaviors. Use of antipsychotics nearly tripled in the past two decades in the United States, with more than 16 million annual prescriptions for drugs such as Abilify, Clozaril and Seroquel. According to a study by Stanford University in 2008, more than half of prescriptions were for “off-label” use not approved safe and effective by the FDA. This latest lawsuit kindles concerns that antipsychotics are being widely and improperly prescribed to millions of Americans each year.
Particularly worrisome is the use of antipsychotics to treat vulnerable patients, including elderly nursing home residents. The federal government alleges that Johnson & Johnson and its subsidiaries promoted the use of the Risperdal for elderly patients with dementia, despite evidence that this would increase their risk of stroke, weight gain and diabetes. According to an audit by the US Department of Health and Human Services, Medicare claims were filed for antipsychotic drugs for 1 in 7 nursing home residents over the age of 65, with 83% attributed to off-label use. Antipsychotic drugs are increasingly used to treat problems related to dementia in older adults, though the medication has proven more effective for sufferers of schizophrenia and can cause serious side effects.
Antipsychotics are not the only drugs that are commonly misprescribed among the elderly. In 2011, a study published by the British Medical Journal suggested that the prescription of antidepressants may need to be reevaluated as well. The study showed that adults over 65 who took newer generation antidepressants – known as serotonin reuptake inhibitors (SSRIs) including Prozac and Zoloft – had a greater risk of having a stroke, seizures and higher salt levels in the blood than those who took older medications, known as tricyclic antidepressants (TCAs). These findings are contrary to the prevailing view that SSRIs are safer than TCAs.
In 2012, antidepressants were tied to a higher risk of falls
for nursing home residents, especially those with dementia.
While antipsychotics are used to manage psychosis symptoms related to schizophrenia and bipolar disorder, antidepressants are used to treat disorders like depression or anxiety and are intended to alter mood. As with antipsychotics, the use of antidepressants has increased since 1990 and has been a subject of much debate. Medical News Today reported that in 2012, antidepressants were tied to a higher risk of falls for nursing home residents, especially those with dementia.
Although all prescription medications can have adverse side effects, physicians and drug manufacturers have an ethical obligation to disclose the associated risks and potential
alternatives to patients or family members.
The American Journal of Geriatric Pharmacotherapy reported in 2011 that nearly 50% of nursing home residents are given antidepressants, though there is little knowledge available regarding how antidepressants are prescribed. Many may be dispensed solely on the basis of nurses’ observations or patient’s behavior rather than a proper diagnosis by a doctor.
Although all prescription medications can have adverse side effects, physicians and drug manufacturers have an ethical obligation to disclose the associated risks and potential alternatives to patients or family members.
The prevalence of lawsuits associated with antipsychotic and antidepressant drugs sends a strong message to drug manufacturers that they must practice full disclosure regarding the possible side effects, uses and abuses of psychiatric medications – and practitioners should exercise much greater caution in prescribing them.
Okun Oddo & Babat specializes in Medical Malpractice and Medical Negligenceclaims. Contact us today or call or call us at 212.642.0950 to arrange an appointment with one of our experienced New York attorneys.