Post by norbert1 on Sept 2, 2008 21:10:23 GMT -5
Understanding the "Black Box" warning for antipsychotic medications.
Question - I read information from makers of Seroquel with all kinds of scarey stuff...I am used to disclaimers but this specifically states "Seroquel is not approved for dementia patients....what's what with this the inquiring mind wonders. H/C
Response - The explanation of the warnings for antipsychotics is long and complex.
It began a few years ago when they were running a study on Zyprexa in Canada. They observed that there was a slightly higher stroke rate in patients (dementia patients?) who were taking the med. So the Canadian drug agency issued a warning and Zyprexa added a warning to its package insert. It turns out that the makers of risperdal had seen the same effect and had had a similar warning for quite some time.
Some doctors reacted to the initial information by switching back to “conventional” antipsychotics like Haldol and Thorazine, but a later study showed that the harsher conventional antipsychotics had a greater risk that the newer “atypical” antipsychotics” (Seroquel, Risperdal and Zyprexa). And eventually, the warning was applied to all antipsychotics.
The US FDA did a review of various trial data that had been submitted over the years and determined that there is a slightly increased risk of death from cerebral-vascular events (strokes) in dementia patients who took various antipsychotics. The FDA eventually ordered a “Black box warning” on all antipsychotics. Included in the warning is the statement “Seroquel (or this antipsychotic) is not approved for dementia patients.”
Because the tests that are submitted to FDA are considered to be private property of the drug companies that submitted them, the FDA will not disclose the results that influenced the warning decision. A later public meta-analysis study looked at data from all published studies and determined that there is an increased risk to dementia patients. Meta analysis of different studies done with different criteria is a very inaccurate way to study something, but it does indicate that there is a basis for the concern. The study indicated a 1 to 2 percent increased risk of death from cerebral-vascular event (stroke).
Overall, this warning statement by the FDA is cynical, self serving and designed to confuse consumers, and is not helpful.
This warning was issued shortly after the Vioxx debacle, when it was eventually discovered that Vioxx created an increased risk for heart patients. The FDA received a lot of criticism for approving the drug in the first place. So when the antipsychotic issue came along less than a year later, they had to be seen taking strong action.
The fact is, that only 4 medicines are approved for dementia patients (specifically, approved for treating the actual dementia). Other medicines (diabetes, heart, blood pressure) are not specifically approved for dementia patients. And there is nothing illegal about using a med for more than the original purpose it was approved for. Most meds are given for off label purposes, or for age groups that the meds were never tested on, or for patients with a co-existing illness.
Ok, the antipsychotic issue is a little more complex than the usual “off-label” issue. Antipsychotics are approved for people with severe psychosis - specificly people with schizophrenia. Well it turns out that people with dementia often have psychosis. The psychosis is caused by a similar imbalance of neurotransmitters and the meds work for psychosis of dementia also, although much lower doses are required.
When most people read “Seroquel is not approved for dementia patients” what they think is that Seroquel is NOT SUPPOSED to be given dementia patients. That is not what it says. The statement is actually a CYA statement that states that this is an off label use. But those who do not understand how the drug approval process works, think that the statement means something much worse. You may remember EV’s stepson who found that statement and was determined that the med was inappropriate, dangerous, and prohibited. The second-guessing by someone who was not involved in the treatment decisions with the doctor created a great deal of trouble.
I do not want to minimize the risks that come with antipsychotics. There has always been some risk from Antipsychotics. Seroquel seems to be the one with the lowest side effect profile, but is well known for weight gain. Because of this, there is an associated risk of diabetes development. There is now an increased understanding that vascular factors seems to play a part in Alzheimers, so this risk is consistant with things being discover about the disease. And you have to remember that this is an at-risk group of people, who already have a terminal illness and usually, other chronic illnesses. So yes, there is a SMALL risk of having MAJOR complication with this med. It is the choice of the devil.
How have dementia doctors responded to all this? The problem is that there are no other meds that can be used for psychosis and agitation and aggression in dementia patients, so the meds are still widely used. There is little choice if treatment is needed. So doctors pay more attention to heart and stroke risk factors, and treat if necessary. And they use the meds at the lowest possible doses.
Most caregivers realize that this is a quality of life issue, vs quantity of life. If the person is tormented by psychosis (hallucinations or delusions) or they post a risk to themselves, caregivers or other residents, then treatment is needed. It is a matter of quality of life and ability to receive appropriate care.
Norbert
Article about the black box warning
pn.psychiatryonline.org/cgi/content/full/40/9/1
FDA announcement of the black box warning
www.fda.gov/cder/drug/advisory/antipsychotics.htm
Official seroquel information sheet
www.astrazeneca-us.com/pi/seroquel.pdf
www.newsinferno.com/archives/1457#more-1457
February 27th, 2007 A new report published in the current issue of the Canadian Medical Association Journal (CMAJ) claims that, among elderly patients, “the risk of death associated with conventional antipsychotic medications is comparable to and possibly greater than the risk of death associated with atypical antipsychotic medications.
www.thestar.com/article/221474
Dr. David Conn, co-chair of the Canadian Coalition for Seniors' Mental Health, said the organization released guidelines more than a year ago that focus on treating depression and behaviour in long-term care facilities.
"In our guidelines we say you should only use atypical antipsychotics if there's a risk of harm or if there's great suffering or disability caused by the symptoms," he said.
------------------------
Warning extended to older “typical” antipsychotics
FDA Warns About Some Psychiatric Drugs
By MATTHEW PERRONE, AP
Posted: 2008-06-18 11:22:40
WASHINGTON (June 17) -- The Food and Drug Administration warned doctors Monday that prescribing a certain group of psychiatric drugs to seniors suffering from dementia can increase their risk of death.
Antipsychotic drugs are approved to treat schizophrenia and bipolar disease, but doctors frequently prescribe them to treat elderly patients with dementia.
FDA's announcement was an update to a 2005 action, when regulators added warnings about increased heart attacks and pneumonia to drugs called atypical antipsychotics. The medicines include blockbusters like Eli Lilly & Co.'s Zyprexa and Johnson & Johnson's Risperdal.
FDA said Monday those same risks apply to 11 older drugs known as typical antipsychotics, including Pfizer's Navane and Endo Pharmaceutical's Moban. (..also Haldol and Thorazine..) The drugs were developed in the 1950s and have largely been replaced by the newer medications, which are believed to have fewer side effects, such as tremors.
Under FDA's orders, both drug types will now carry boxed warnings ? the most serious a drug can carry ? describing their risks to dementia patients.
Analysts did not expect the announcement to negatively impact drug company earnings because the original antipsychotics are available as low-cost generics.
Federal officials have repeatedly urged doctors not to medicate seniors unnecessarily. Despite such warnings, health professionals continue to prescribe psychiatric drugs "off-label," or for uses that have not been approved by FDA. About 20 percent of seniors in nursing homes who receive antipsychotics have not been diagnosed with psychiatric problems, according to data released by Medicare earlier this year.
While FDA regulates the approval and marketing of drugs, doctors are free to use their judgment when prescribing drugs.
The agency based its decision on two studies of a combined 65,000 seniors which showed those taking antipsychotics were more likely to die than those not on the drugs. Agency officials said it's not clear why antipsychotics hasten death. Scientists also could not determine from the data whether one group carries greater dangers than the other.
"We've struggled with this decision but we ultimately decided the data are strong enough to expand this label to drugs in both classes," said Thomas Laughren, director of FDA's psychiatric drug division.
Question - I read information from makers of Seroquel with all kinds of scarey stuff...I am used to disclaimers but this specifically states "Seroquel is not approved for dementia patients....what's what with this the inquiring mind wonders. H/C
Response - The explanation of the warnings for antipsychotics is long and complex.
It began a few years ago when they were running a study on Zyprexa in Canada. They observed that there was a slightly higher stroke rate in patients (dementia patients?) who were taking the med. So the Canadian drug agency issued a warning and Zyprexa added a warning to its package insert. It turns out that the makers of risperdal had seen the same effect and had had a similar warning for quite some time.
Some doctors reacted to the initial information by switching back to “conventional” antipsychotics like Haldol and Thorazine, but a later study showed that the harsher conventional antipsychotics had a greater risk that the newer “atypical” antipsychotics” (Seroquel, Risperdal and Zyprexa). And eventually, the warning was applied to all antipsychotics.
The US FDA did a review of various trial data that had been submitted over the years and determined that there is a slightly increased risk of death from cerebral-vascular events (strokes) in dementia patients who took various antipsychotics. The FDA eventually ordered a “Black box warning” on all antipsychotics. Included in the warning is the statement “Seroquel (or this antipsychotic) is not approved for dementia patients.”
Because the tests that are submitted to FDA are considered to be private property of the drug companies that submitted them, the FDA will not disclose the results that influenced the warning decision. A later public meta-analysis study looked at data from all published studies and determined that there is an increased risk to dementia patients. Meta analysis of different studies done with different criteria is a very inaccurate way to study something, but it does indicate that there is a basis for the concern. The study indicated a 1 to 2 percent increased risk of death from cerebral-vascular event (stroke).
Overall, this warning statement by the FDA is cynical, self serving and designed to confuse consumers, and is not helpful.
This warning was issued shortly after the Vioxx debacle, when it was eventually discovered that Vioxx created an increased risk for heart patients. The FDA received a lot of criticism for approving the drug in the first place. So when the antipsychotic issue came along less than a year later, they had to be seen taking strong action.
The fact is, that only 4 medicines are approved for dementia patients (specifically, approved for treating the actual dementia). Other medicines (diabetes, heart, blood pressure) are not specifically approved for dementia patients. And there is nothing illegal about using a med for more than the original purpose it was approved for. Most meds are given for off label purposes, or for age groups that the meds were never tested on, or for patients with a co-existing illness.
Ok, the antipsychotic issue is a little more complex than the usual “off-label” issue. Antipsychotics are approved for people with severe psychosis - specificly people with schizophrenia. Well it turns out that people with dementia often have psychosis. The psychosis is caused by a similar imbalance of neurotransmitters and the meds work for psychosis of dementia also, although much lower doses are required.
When most people read “Seroquel is not approved for dementia patients” what they think is that Seroquel is NOT SUPPOSED to be given dementia patients. That is not what it says. The statement is actually a CYA statement that states that this is an off label use. But those who do not understand how the drug approval process works, think that the statement means something much worse. You may remember EV’s stepson who found that statement and was determined that the med was inappropriate, dangerous, and prohibited. The second-guessing by someone who was not involved in the treatment decisions with the doctor created a great deal of trouble.
I do not want to minimize the risks that come with antipsychotics. There has always been some risk from Antipsychotics. Seroquel seems to be the one with the lowest side effect profile, but is well known for weight gain. Because of this, there is an associated risk of diabetes development. There is now an increased understanding that vascular factors seems to play a part in Alzheimers, so this risk is consistant with things being discover about the disease. And you have to remember that this is an at-risk group of people, who already have a terminal illness and usually, other chronic illnesses. So yes, there is a SMALL risk of having MAJOR complication with this med. It is the choice of the devil.
How have dementia doctors responded to all this? The problem is that there are no other meds that can be used for psychosis and agitation and aggression in dementia patients, so the meds are still widely used. There is little choice if treatment is needed. So doctors pay more attention to heart and stroke risk factors, and treat if necessary. And they use the meds at the lowest possible doses.
Most caregivers realize that this is a quality of life issue, vs quantity of life. If the person is tormented by psychosis (hallucinations or delusions) or they post a risk to themselves, caregivers or other residents, then treatment is needed. It is a matter of quality of life and ability to receive appropriate care.
Norbert
Article about the black box warning
pn.psychiatryonline.org/cgi/content/full/40/9/1
FDA announcement of the black box warning
www.fda.gov/cder/drug/advisory/antipsychotics.htm
Official seroquel information sheet
www.astrazeneca-us.com/pi/seroquel.pdf
www.newsinferno.com/archives/1457#more-1457
February 27th, 2007 A new report published in the current issue of the Canadian Medical Association Journal (CMAJ) claims that, among elderly patients, “the risk of death associated with conventional antipsychotic medications is comparable to and possibly greater than the risk of death associated with atypical antipsychotic medications.
www.thestar.com/article/221474
Dr. David Conn, co-chair of the Canadian Coalition for Seniors' Mental Health, said the organization released guidelines more than a year ago that focus on treating depression and behaviour in long-term care facilities.
"In our guidelines we say you should only use atypical antipsychotics if there's a risk of harm or if there's great suffering or disability caused by the symptoms," he said.
------------------------
Warning extended to older “typical” antipsychotics
FDA Warns About Some Psychiatric Drugs
By MATTHEW PERRONE, AP
Posted: 2008-06-18 11:22:40
WASHINGTON (June 17) -- The Food and Drug Administration warned doctors Monday that prescribing a certain group of psychiatric drugs to seniors suffering from dementia can increase their risk of death.
Antipsychotic drugs are approved to treat schizophrenia and bipolar disease, but doctors frequently prescribe them to treat elderly patients with dementia.
FDA's announcement was an update to a 2005 action, when regulators added warnings about increased heart attacks and pneumonia to drugs called atypical antipsychotics. The medicines include blockbusters like Eli Lilly & Co.'s Zyprexa and Johnson & Johnson's Risperdal.
FDA said Monday those same risks apply to 11 older drugs known as typical antipsychotics, including Pfizer's Navane and Endo Pharmaceutical's Moban. (..also Haldol and Thorazine..) The drugs were developed in the 1950s and have largely been replaced by the newer medications, which are believed to have fewer side effects, such as tremors.
Under FDA's orders, both drug types will now carry boxed warnings ? the most serious a drug can carry ? describing their risks to dementia patients.
Analysts did not expect the announcement to negatively impact drug company earnings because the original antipsychotics are available as low-cost generics.
Federal officials have repeatedly urged doctors not to medicate seniors unnecessarily. Despite such warnings, health professionals continue to prescribe psychiatric drugs "off-label," or for uses that have not been approved by FDA. About 20 percent of seniors in nursing homes who receive antipsychotics have not been diagnosed with psychiatric problems, according to data released by Medicare earlier this year.
While FDA regulates the approval and marketing of drugs, doctors are free to use their judgment when prescribing drugs.
The agency based its decision on two studies of a combined 65,000 seniors which showed those taking antipsychotics were more likely to die than those not on the drugs. Agency officials said it's not clear why antipsychotics hasten death. Scientists also could not determine from the data whether one group carries greater dangers than the other.
"We've struggled with this decision but we ultimately decided the data are strong enough to expand this label to drugs in both classes," said Thomas Laughren, director of FDA's psychiatric drug division.