I plan to ask our pdoc this afternoon. If I learn anything, I'll post about it.
Forgot to ask the pdoc -- sorry! I was dealing with a child who wouldn't get out of the car to go to his appointment. I guess I was a bit rattled at the appointment.
Here's the FDA Advisory Committee articles. There are 3, the one that displays and then 2 links at the bottom.
Basically it looks like 25 deaths, 19 of which were children, and 12 of those had pre-existing heart disease. Pediatric deaths were .18-.53 per million prescriptions. Plus 54 serious cardiovascular events, with more events in adults than children. These events were .16-.53 per million prescriptions for children.
Ds has an appointment this Wednesday and I will be asking him about it and what would be a prudent course to take. I'll let you know what I find out. Don't worry about it, SmallMom -- I know exactly what you were going through!The numbers are very tiny. That does put it into some perspective. As always, you have to weigh the benefits vs. the risks.
bumped for KarenCee.IMac38944.5312615741
Dead indeed.
I spent some time on the FDA Advisory Committee website looking for them. Interestingly (or disturbingly?), they are now no where to be found.
This has some info, but not the detailed statistics I found before:
http://counsellingresource.com/features/archives/2006/drugs/ adhd-deaths/
It appears that several of the children who experienced sudden death had an underlying disorder known as hypertrophic obstructive cardiomyopathy. This is a heritable disorder that causes increased thickness of the heart muscle.
I wish they would release more detailed information, like how many of the 12 with heart disease had this particular condition, which stimulants they were taking, and what the dosages were.
I agree, NoTellin, information helps with the risk vs benefit evaluations that docs, parents and pateints have to do to make treatment decisions.I agree to. My daughter has a heart valve issue, and the cardiac risks are always a concern to me. Our doctor keep telling me the valve issues are ok.Here's the latest on this topic:
FDA Requires Warning on Cardiac Risks for Stimulant Drugs
8/23/06 -- A new warning on the labels of stimulants used to treat AD/HD will caution physicians not to prescribe the drugs for children or adults with heart problems.
The Food and Drug Administration (FDA) required the warnings after reports of sudden deaths of children who were taking the stimulants. The warnings will be included in the package inserts that come with popular AD/HD medications such as Ritalin, Concerta, and Adderall.
"Although some serious heart problems alone carry an increased risk of sudden death," reads the warning for Ritalin, "stimulant products generally should not be used in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug." The Ritalin label contains a similar warning for adults.
Last February, an FDA advisory panel on medication use recommended the warnings, and another panel comprised of cardiac experts, called for even stronger warnings.
And here's a longer version:
August 21, 2006
F.D.A. Orders Strong Warnings on Stimulants
By GARDINER HARRIS
The New York Times
WASHINGTON, Aug. 21 — Federal drug regulators have ordered that strong
warnings be put on the labels of stimulants like Ritalin to caution against
their use in adults or children with heart problems and to alert physicians
that the drugs cause one child in a thousand to experience hallucinations.
The new warnings are not as strong as those approved in February by an
advisory committee for the Food and Drug Administration, but they
significantly strengthen the risk information already on the drugs.
“We’re not trying to scare people out of using these drugs,” said Dr. Robert
J. Temple, director of the drug agency’s Office of Medical Policy. “Still, I
would be extremely reluctant to put people with heart failure on one of
these drugs.”
The warnings come after scattered reports of children dropping dead suddenly
while taking the drugs. In some cases, the children were later determined to
have had structural defects of the heart.
The new warnings advise against giving such children stimulants. The
problem, though, is that structural heart problems frequently go undiagnosed
because the tests needed to find such problems are often expensive.
“The difficulty for parents is that doctors won’t do a thousand-dollar heart
work-up for every kid,” Dr. Temple said. “The message here, though, is that
you have to do your best to find these problems out. Listen for murmurs.”
Heart problems are more common in adults.
The warnings state in part, “Sudden deaths, strokes and myocardial infaction
have been reported in adults taking stimulant drugs at usual doses.” In
addition to appearing on Ritalin, the warnings will be put on the labels of
Adderall and Concerta.
At a meeting in February, an F.D.A. advisory committee focused attention
unexpectedly on stimulants’ risks in adults after a report suggested that
the drugs might double the risk for strokes and serious arrhythmias in
children and adults. Such an increase may not be significant in children,
whose overall heart risks are low, but could cause concern in adults,
members said.
Dr. Steven E. Nissen, chairman of the cardiology department at the Cleveland
Clinic Foundation and a prominent member of the February committee, said in
an interview that he was pleased with the drug agency’s action.
“I think this goes a long way,” Dr. Nissen said, “toward properly warning
physicians and patients of the potential cardio and psychiatric risks of
these drugs.”
Nearly four million people take stimulants to treat attention deficit
disorder and hyperactivity, and their use is growing fastest in adults.
One drug, Ritalin, has been marketed since 1955, and dozens of studies have
shown it to be safe and effective. But no studies have been of sufficient
duration or included enough participants to evaluate stimulants’ long-term
effects on the heart.
Advisory committee members said they were concerned that any heart risks
affecting adults who took stimulants could go undetected. Dr. Temple said
the drug agency was exploring ways to study the problem.