Antipsychotic Drugs Black Box Warning. Use of antipsychotic drugs like Risperdal and Seroquel to control dementia patients has risen in recent years, despite the Food and Drug Administration’s (FDA) “black box” warning labels that these drugs can increase the risk of death for elderly dementia sufferers.
About 30% of nursing home residents are on antipsychotic drugs, according to the Centers for Medicare & Medicaid Services (CMS), most of them on newer, atypical antipsychotics. Federal law strongly discourages nursing homes from physically restraining unruly patients, but federal health-care programs such as Medicaid pay for drugs that may help calm aggressive behavior and agitation associated with Alzheimer’s.
In 2005, Medicaid spent $5.4 billion on atypical antipsychotic medicines—more than it spent on any other drug class, including antibiotics, AIDS drugs, or high blood pressure. Atypical antipsychotics are approved for schizophrenia and bipolar disorder, but in what is known as “off label” use—use not approved by the FDA for FDA-approved medications—doctors often prescribe the drugs to dementia patients.
The widespread use of antipsychotics among the elderly has begun to draw criticism from regulators, researchers, lawmakers, and the nursing-home industry. Senator Charles Grassley, the ranking Republican on the Senate Finance Committee, asked several drug manufacturers for records on how they may have marketed these drugs for use in geriatric patients and also has asked the Inspector General of the Department of Health and Human Services to investigate use of the drugs in nursing homes.
The $122 billion nursing-home industry has moved toward large
The $122 billion nursing-home industry has moved toward large, often understaffed, institutions where use of psychotropic drugs is rising. According to CMS, nearly 21% of nursing-home patients who don’t have a psychosis diagnosis are on antipsychotics. A 2005 study found antipsychotics were prescribed not only for psychosis, but for depression, confusion, memory loss, and feelings of isolation. Last year, CMS instituted new guidelines to limit the use of antipsychotics; however, it’s still easier for nursing homes to get reimbursed for giving patients extra pills than it is for hiring extra staff.
An Alzheimer’s patient often cannot refuse antipsychotic drugs, says Cynthia Rudder, of the Long-Term Care Community Coalition. “You are basically quieting them against their will and it is absolutely horrendous,” she says. Family members can object to the use of such drugs, but risk having their relative discharged for unruly behavior.
At CMS, officials stress the need to shift to smaller, less-rigid facilities as a way to reduce antipsychotic usage. Some nursing-home-industry officials agree change is needed, yet replacing drugs with approaches that require a more human touch is easier said than done.
There are some Alzheimer’s patients for whom nonpharmacological approaches simply don’t work
There are some Alzheimer’s patients for whom nonpharmacological approaches simply don’t work, says William Thies, a vice president at the Alzheimer’s Association in Chicago, and in these cases antipsychotics may be warranted. But the drugs need to be used very carefully, at the lowest dose and after ruling out a medical problem, says Thies, who has a doctorate in pharmacology.
A spokesman for AstraZeneca Pharmaceuticals LP, maker of Seroquel, says “decisions about medical treatment are made by physicians” and the company doesn’t recommend the drug “for uses other than its approved indications in schizophrenia and bipolar disorder.”
But according to the Wall Street Journal, some pharmaceutical companies have attracted scrutiny for marketing drugs for unapproved uses. It is illegal for drug makers to promote off-label uses, but doctors may prescribe medications as they see fit. Last month, the Arkansas attorney general filed suit against Johnson & Johnson and two of its units, claiming, among other things, that they “engaged in a false and misleading campaign” to promote its antipsychotic drug Risperdal to geriatric patients.