CNN Money - Do ADHD drugs cause heart attacks in children?

[Guest guest]

SSRI-Research@

Fri, 3 Feb 2006 17:28:38 -0500

[sSRI-Research] CNN Money - Do ADHD drugs cause heart attacks

in children?

 

 

FYI

 

http://money.cnn.com/2006/02/01/news/companies/adhd/index.htm?section=money_late\

st

 

FDA eyes heart risks of ADHD drugs

 

Agency wants know if medication for attention deficit hyperactivity

causes heart attacks in children.

 

By Aaron Smith, CNNMoney.com staff writer

February 2, 2006: 8:59 AM EST

 

NEW YORK (CNNMoney.com) - Do ADHD drugs cause heart attacks in children?

 

Following a temporary suspension of Adderall XR in Canada last year,

the Food and Drug Administration wants to find ways to study the

long-term heart risks of drugs for Attention Deficit Hyperactivity

Disorder.

 

Although this sort of news can cause parental panic, there's no proof

that these drugs cause fatal heart attacks. And Ritalin, the most

recognizable name in ADHD treatments, has been FDA-approved and on the

market for half a century. The first kids who took Ritalin are now old

enough to be concerned about the new Medicare bill. So Ritalin, a

Novartis (up $0.44 to $55.60, Research)-produced drug that lost patent

protection decades ago, is not a new drug with unseen long-term side

effects.

 

The FDA will be taking a close look at ADHD drugs at an advisory

committee on Feb. 9. It is responding to reports of sudden death,

heart attack, stroke and hypertension in children and adults

takingADHD drugs, the agency said.

 

The committee will try to find the best way to test the drugs for

cardiovascular risks in long-term use.

 

Although it won't get specific about ADHD products or drug makers, the

agency appears to be talking primarily about Adderall XR, the market

leader produced by the British company Shire (Research). The FDA

issued an alert in 2005 that a Canadian health care agency had pulled

Adderall XR off the market because of reports of sudden unexplained

death in children taking the drug. It was returned to shelves six

months later.

 

ADHD is a mental disorder that impairs concentration and the ability

to control behaviorin four percent of U.S. adults and three percent to

seven percent of children, according to the American Psychiatric

Association. The three drugs are based on separate compounds:

methylphenidate hydrochloride for Ritalin; atomoxetine hydrochloride

for Strattera, produced by Eli Lilly & Co (up $0.27 to $56.89,

Research).; and Adderall XR is an amphetamine. Sold as a generic by

various companies, methylphenidate sales totaled $60 million in 2004,

according to the most recent figures from Verispan/Drug Topics. This

pales in comparison to revenue from its branded competitors: $552

million in 2005 sales for Lilly's Strattera, and $607 million in 2004

sales for Shire's Adderall XR, in the most recent figures available.

 

 

 

On its label, Adderall XR warns that amphetamine misuse may " cause

sudden death and serious cardiovascular adverse events. " Since 2005,

Strattera has carried an FDA warning label that the drug could

increase the risk of suicidal thinking in children and teens, which is

the type of warning generally applied to antidepressants. Strattera

and Ritalin do not carry warnings of potentially fatal heart problems

-- although Ritalin's label urges caution in use with patients with

hypertension.

 

Adderall Risks?

Adderall XR, a longer-acting version of Adderall, was yanked off the

Canadian market for six months in 2005 because of reports of 20 sudden

deaths and 12 strokes in adults and children using the drug. In

February, 2005, the FDA sent out an alert that Health Canada, a

government health care agency, had suspended marketing of Adderall XR

products " due to concern about reports of sudden unexplained death in

children taking Adderall and Adderall XR. "

 

But the FDA alert also said there was " a very small number of cases "

and that the agency " cannot conclude that recommended doses of

Adderall can cause [sudden unexplained death.] " The FDA did not pull

Adderall XR from the market. Health Canada allowed Adderall XR to

return to the market in August 2005, with a warning about misuse of

the drug and the fact that it should not be used in patients with

" structural cardiac abnormalities. "

 

Matt Cabrey, a spokesman for Shire, said there is no proven link

between Adderall and sudden deaths in any patients, and that there

have been more than 50 million prescriptions for Adderall products

since their FDA approval in 1996. Referring to the upcoming FDA

meeting, Cabrey said it's " an important process and Shire is

supportive of the committee evaluation. "

 

Dr. Andrew Adesman, chief of Developmental and Behavioral Pediatrics

at Schneider Children's Hospital in Lake Success, N.Y. and an ADHD

expert, believes that Adderall XR did not likely cause the pediatric

deaths.

 

Sudden death from heart attacks does occur in children, but it is

rare, and no link to ADHD drugs has been proven.

 

" Adderall XR is back on the market in Canada, because after review it

was not clear that Adderall XR was contributing to these risks, " said

Adesman. " As rare and horrible as these cases are, there's no clear

link to medication. So the issue [for the FDA] is teasing out whether

there's a risk specific to medication, or whether this is an expected

outcome given the numbers of children treated. "

 

But if the risk of death seems slim or nonexistent, why is the FDA

scrutinizing ADHD drugs?

 

Adesman said the FDA was " put in an awkward light " by the Adderall

XR's temporary suspension in Canada last year and " is obligated to

make sure it has the information it needs to be sure that the

medicines are as safe as they believe they are. "

 

-------