New warnings for anti-psychotic drugs and elderly patients
You have to wonder, what took so long?
On Monday, the Food and Drug Administration announced that it would require strong warnings on anti-psychotic drugs advising that they raise the risk of death in older people with dementia.
At issue are so-called “conventional” anti-psychotic medications such as Haldol, Compazine, Mellaril and Thorazine. (For a complete list, see the FDA’s press release <http://www.fda.gov/bbs/topics/NEWS/2008/NEW01851.html> .) A similar warning was issued for “atypical” anti-psychotics, including Risperdal and Zyprexa, in 2005.
Neither class of medication is approved for elderly dementia patients, but they’re frequently prescribed any way for symptoms such as agitation, combativeness or out-of-control behavior. The FDA gives doctors discretion to prescribe for “off label” purposes.
At a press conference Monday, FDA officials said two recent scientific studies supplied justification for the expanded warnings. Yet the drugs’ dangers have been known for years.
In December 2005, only months after the first FDA warning, an important study in the New England Journal of Medicine found that conventional anti-psychotics were “at least as likely as atypical agents to increase the risk of death among elderly persons.”
Also, in June 2007, an article in the Annals of Internal Medicine concluded that conventional anti-psychotics were associated with a higher risk of death than atypical medications.
It’s an issue with widespread significance for the frail elderly. Some experts suggest as many as one in every four nursing home residents may be taking anti-psychotics. Last year, David Graham, a well-known FDA whistleblower, suggested the medications might be responsible for the deaths of 15,000 nursing home patients every year.
The really important question is whether anti-psychotic drugs are truly necessary or whether they’re used to sedate dementia patients in homes that are under-staffed and ill prepared to meet complex patients’ needs.
I spoke to Dr. Dan Loiterstein, a geriatric psychiatrist at Rush University Medical Center, late Monday and asked him to help interpret the FDA’s actions.
Q. Will this change the medications prescribed for patients with dementia in nursing homes?
A. Probably not. It’s been known since late 2005 that there’s a mortality risk associated with these drugs. It’s not news within the educated medical community.
Q. And yet, a lot of older people with dementia are being prescribed anti-psychotic drugs. Is that unfortunate?
A. Maybe. Using these medications is always your last choice in treating the neuropsychiatric symptoms of dementia. Unfortunately, with a lot of patients we’ve reached that threshold.
Q. How would you define that threshold?
A. We’re not able to control their behavior with other modifications, such as trying to change their environment or increase their level of care. Sometimes, when you have patients who become combative or agitated, in order to provide for the safety of patients and a caregiver, you need to give these medications.
Q. Can you give an examples of something in the environment that could be modified?
A. Certainly, you want to look for pain. If you’re moving someone around in bed and they’re in pain and they can’t communicate, that might be expressed as agitation or combative behavior.
Or, if someone is exhausted they may become more easily irritated. You’d want to think about ways to keep them stimulated, meaningful ways to keep them engaged so they don’t sleep during the day and stay awake at night.
Q. So, is this really just a matter of the FDA catching up?
A. It certainly seems that’s the case.