New Warning For Anti-Psychotic Drugs

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 <> .)  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. 



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