Drug warnings
too late for Andrea Yates; Medical experts blast FDA
over new antidepressant warning
AUSTIN, Texas, July 10 /U.S.
Newswire/ -- While Andrea Yates's defense team argued about whether
or not she was sane when she drowned her five children, medical
experts told reporters that patients, like Andrea Yates, are not
adequately warned about the powerful and potentially dangerous
effects of antidepressant drugs.
In November 2005, more than four
years after the Andrea Yates tragedy, the FDA and Wyeth
pharmaceuticals agreed to warn patients and their doctors about the
risk of homicidal thoughts in relation to Effexor XR, an
antidepressant Yates was taking when she drowned her five children.
According to drug expert,
Professor James O'Donnell PharmD, and Moira Dolan M.D. of the
Medical Accountability Network, the warning is buried so deep in the
prescription information that nobody is likely to read it.
"I think that Wyeth should be
commended for being the first to put hostility and suicide warnings
on their label. Now they have an obligation to warn about homicidal
ideation, particularly when you consider the gravity of a homicidal
effect" said Dolan, executive director of the Medical Accountability
Network. "At the least the FDA should have required a 'dear doctor'
letter to be sent to physicians. I can tell you that doctors don't
have time to surf the Internet to find these labeling changes."
Dolan was also concerned about the
content of the warning itself. "Once you do find the modified label,
you would have to get all the way to the bottom of page 36 before
finding out that homicidal ideation was a possibility," said Dolan.
"How likely is it that anybody is going to find that?"
O'Donnell said that characterizing
these effects as "rare" was potentially misleading as well. "Rare
effects are simply those that occur in less than one in a thousand
patients," said O'Donnell. "To put this in perspective, in 2005
there were over 19 million prescriptions for Effexor XR. This could
easily equate to over a million people taking the drug. That means
that if the rate of homicidal ideation is anywhere near 1 in 1,000
patients, we could have tens, hundreds, or even a thousand people
out there thinking about killing people. If we've learned anything
from the Yates case, it's that even one such incident can have
tragic results."
O'Donnell further points out that
patients exhibiting any form of hostility are eliminated from drug
trials routinely, a practice for which pharmaceutical companies have
come under fire.
O'Donnell also expressed concern
that in many cases psychiatric patients are not monitored and that
the drugs themselves can increase the risk of a patient becoming
psychotic. This, he said, can cause an involuntary intoxication in
victims, bringing them to harm themselves and others through no
fault of their own. "Rapid changes in dose can result in devastating
psychiatric toxicities, including agitation, aggression and
violence," O'Donnell said.
"Having reviewed Andrea Yates's
full medical record, I have no doubt that this was a case of toxic
psychosis," said Dolan. "The records revealed that Andrea was put on
drugs that aren't even indicated for depression. When she did get
antidepressants, at least one of them was prescribed in
extraordinary doses. It's absolutely tragic that Effexor XR didn't
carry any warning about potential homicide risk until long after
Andrea's children were dead."
"In 2003, Wyeth Pharmaceutical
tried to warn doctors that children could experience hostility and
become suicidal while taking Effexor XR," O'Donnell said, citing a
letter that Wyeth sent to physicians. "The FDA made them withdraw
that warning, citing a need to include the warning for all drugs in
this class."
"Every mother who goes to her
doctor with the blues is at risk," Dolan warned.
Dolan and O'Donnell said they will
be exploring this further and sending complaints to the appropriate
authorities.
-----
Dr. Moira Dolan is Board Certified
in internal medicine and is the executive director of the Medical
Accountability Network. She has testified before an FDA Advisory
Committee on the content of drug label information.
James O'Donnell PharmD MS ABCP CNS
FACN R.Ph. is an author, consultant and associate professor at Rush
Medical College in Chicago. He has testified before a congressional
committee on psychiatric toxicities from other prescription drugs.
The Medical Accountability Network
is a private nonprofit organization of health care professionals
dedicated to the restoration of integrity in medicine. The group
considers that informed consent is the keystone to an ethical
physician patient relationship. Through advocacy, investigation and
education the Medical Accountability Network raises the
responsibility level of participants in all aspects of the
professional and public communities affected by medical issues. More
information can be found on its Web site:
http://www.medicalaccountability.net