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ADHD/Adderal XR/deaths

The TVClubHouse: General Discussions ARCHIVES: 2005 Dec. ~ 2006 Feb.: Parenting Place: ADHD/Adderal XR/deaths users admin

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Julieboo
Member

02-05-2002

Friday, February 10, 2006 - 9:22 am   Edit Post Move Post Delete Post View Post Send Julieboo a private message Print Post    
They are reporting that 25 deaths have been a result of taking adderal. Anyone have any information? I heard it is not allowed in Canada.

Landi
Member

07-29-2002

Friday, February 10, 2006 - 9:56 am   Edit Post Move Post Delete Post View Post Send Landi a private message Print Post    
who is "they"? what is the source? please post these kinds of things, otherwise it is senstationalism journalism.

Julieboo
Member

02-05-2002

Friday, February 10, 2006 - 10:02 am   Edit Post Move Post Delete Post View Post Send Julieboo a private message Print Post    
It's been all over our local news. Thought it was like that everywhere. I'll see what I can post...

Julieboo
Member

02-05-2002

Friday, February 10, 2006 - 10:05 am   Edit Post Move Post Delete Post View Post Send Julieboo a private message Print Post    
From USA TODAY:
Posted 2/9/2006 10:30 AM Updated 2/10/2006 7:48 AM

Warnings advised on ADHD drugs
By Rita Rubin, USA TODAY
WASHINGTON — A Food and Drug Administration advisory panel on Thursday narrowly voted to recommend putting the strongest type of warning possible on widely prescribed stimulant drugs for attention deficit/hyperactivity disorder, or ADHD.
The FDA had asked the committee to consider what types of studies could be used to look at whether the drugs, which include Ritalin, Adderall, Focalin, Methylin, Metadate and Concerta, increase the risk of sudden death, heart attacks or strokes.

An FDA report released prior to the meeting said that 25 children and adults had died suddenly from 1999 to 2003 after taking ADHD drugs.

Doctors wrote more than 31 million prescriptions last year for stimulant ADHD drugs, according to IMS Health, a pharmaceutical information company.

Concern about cardiovascular risk led the FDA's counterpart in Canada, Health Canada, to pull Adderall off the market a year ago, but sales there later resumed. Adderall, the only amphetamine among the top-selling ADHD brands, already carries a boxed warning about how misuse might cause sudden death, heart attack or stroke.

Gerald Dal Pan, director of the FDA's Office of Drug Safety, wrote in a memo to the advisory panel that the reports of adverse reactions don't prove the drugs caused the problems.

Robert Temple, director of the FDA's Office of Medical Policy, said that although the agency doesn't need ironclad proof before warning patients about possible drug risks, "We still believe that what you tell people should reflect the available data. We didn't find the sudden death data very persuasive."

He said the FDA doesn't want to "overscare" people who might benefit from taking important drugs.

Advisory panel member Curt Furberg, a medical professor at Wake Forest University, said it could take years for studies to answer the question about whether the ADHD drugs increase the risk of cardiovascular problems. Meanwhile, he said, doctors and patients and their families should be alerted to the possibility.

In an 8-7 vote, the panel recommended prominently displaying information about possible cardiovascular risks in a "black box" warning on the drugs' labels and package inserts.

In a 15-0 vote, the panel also recommended that the FDA require "Medication Guides" that would explain possible risks in plain English to patients and their families. Some of the drugs already have such guides.

The FDA doesn't have to follow its advisory panels' recommendations, but usually does.

Julieboo
Member

02-05-2002

Friday, February 10, 2006 - 10:10 am   Edit Post Move Post Delete Post View Post Send Julieboo a private message Print Post    
from ABC news:
FDA report details 25 deaths in children and adults given ADHD drugs

February 9, 2006 - Ritalin and other stimulant drugs for attention deficit hyperactivity disorder should carry the strongest warning that they may be linked to an increased risk of death and injury, federal health advisers said Thursday.

A Food and Drug Administration advisory panel voted in favor of the "black box" warning after hearing about the deaths of 25 people, including 19 children, who had taken the drugs. The vote of the Drug Safety and Risk Management advisory committee was 8-7, with one abstention. One committee member, Dr. Curt Furberg, a professor of public health sciences at the Wake Forest University Baptist Medical Center, said it would be "inappropriate, unethical behavior" not to disclose that there was uncertainty about the safety of the drugs.
The FDA is not required to follow the recommendations of its advisory committees but typically does.

"The committee plainly wanted to tell us certain things ought to be in labeling in a more forceful way," Dr. Robert Temple, director of the FDA's Office of Medical Policy, told reporters after the meeting.

Doctors prescribe the drugs to about 2 million children and 1 million adults a month.

Drugs that would have to carry the warning labels are methylphenidates, which are sold as Ritalin, Concerta, Methylin and Metadate. The labels for Adderall and Adderall XR, both amphetamines, have included the warnings since 2004.

The advisory committee also recommended that the drugs include a medication guide for patients and parents. The vote on that was 15-0, with one abstention.

Adderall is made by Shire Pharmaceuticals; Ritalin by Novartis Pharmaceuticals Corp.; Concerta by Johnson & Johnson; Methylin by Mallinckrodt Pharmaceuticals; and Metadate by UCB. Other companies make generic versions of Ritalin.

The black box warning would not apply to Strattera, manufactured by Eli Lilly and Co. That drug is not a stimulant.

Julieboo
Member

02-05-2002

Friday, February 10, 2006 - 10:12 am   Edit Post Move Post Delete Post View Post Send Julieboo a private message Print Post    
I mean, what are we supposed to do with this information? Does it mean the kids should be taken off the meds? Which way of guilt do we go with? Option A; Keep the kids on the meds and maybe they die? or Option B; Take the kids off the meds, and they struggle every day in school and in learning?

Landi
Member

07-29-2002

Friday, February 10, 2006 - 10:46 am   Edit Post Move Post Delete Post View Post Send Landi a private message Print Post    
after reading this initially, i went and searched for news reports also. if you consider the amount of prescriptions written on a yearly basis, this is a SMALL amount. there were 31 MILLION prescriptions of ADD/ADHD medications written last year. Adderall is also an amphetamine based prescription, most are not. every medication has warnings and risks. A clear monitoring system needs to be in place by your child's physician. I know that my daughter is checked on a 3 month basis, for any changes in her normal system. she has organ checks, multiple blood and lab tests done.

considering that a DEA form is needed to acquire this medication and that parents should be totally informed before putting them on any and ALL medications. don't forget their is a risk of death for aspirin also.

you could always take the christian science approach and just pray and say "no" to all medications, as they all have risks.


Julieboo
Member

02-05-2002

Friday, February 10, 2006 - 10:58 am   Edit Post Move Post Delete Post View Post Send Julieboo a private message Print Post    
landi, do you know if it is "standard" for a kid on adderal to have blood tests every time they go in for an ADHD check?

My pediatrician has done no bloodwork whatsoever. They check his weight, height, blood pressure and temp. That's it. I am so unsure of him. When he called me back this morning, the first thing he told me was that he had not read the report. WHAT? Isn't that his responsibility? If for no other reason to calm us nervous parents down?

What is a DEA form?

Landi
Member

07-29-2002

Friday, February 10, 2006 - 11:12 am   Edit Post Move Post Delete Post View Post Send Landi a private message Print Post    
a DEA form is the triplicate prescription form that is required to process the stimulant prescription. it's not one of those little regular slips of paper that prescriptions are normally written on.

not every time does she get a blood test. but one should have been done at the beginning of starting any stimulant medication and usually every 6 months. if you want more done, REQUEST more to be done.

i'm not a nervous parent about these newspaper articles. now if the rate was higher than 25 people and considering that this was adults AND children, my nervousness might increase, but it would have to be a significantly higher number. also this isn't the medication that my daughter is on.

ADD/ADHD went through similar journalism a few years back. it brings up a hysteria that is unwarranted, and then it dies down again. this two shall pass.

julie if your child is growing at an acceptable rate compared to what he was before medication, via his weight/heigh/blood pressure tests, etc. i wouldn't be that concerned. but then again that is my opinion. i've just lived through it for the last 12 years.


Gemma120in2002
Member

07-05-2003

Sunday, February 12, 2006 - 10:40 am   Edit Post Move Post Delete Post View Post Send Gemma120in2002 a private message Print Post    
I have a child with ADHD and she takes Concerta and she is doing just fine.. I have ADD and I take Concerta too. I also had two strokes, and congestive heart failure 13 years ago, before I was diagnosed with ADD, and have had no problems at all with this medication.

Let me state clearly, the medication did NOT cause my strokes or my heart failure. A urinary tract infection caused them!!!

I've never had a blood test for this medication and neither has my daughter. We both have our weights checked and have our blood pressure monitored.

If you are concerned about your doctor's attentiveness to your daughter's health, then maybe you should look for another doctor.

These medications have been around for more than 30 years, and there have been very few adverse reactions reported until very recently. My doctor told me that many of the problems in the adults and children who have died can be related to illegal drug use. Unfortunately one of the terrible side effects of being ADD / ADHD is that drug use and other dangerous behaviors can be directly related to the condition.

Unfortunately the whole condition can be very overwhelming, and trying to deal with it and treat it properly without going crazy can be a real challenge.