New Heart Alert for Some ADHD Drugs
Strongest Warning Focuses on Amphetamine-Based Drugs
Aug. 22, 2006 -- Amphetamine-based drugs for ADHD, such as Adderall and
Dexedrine, now come with a new, expanded 'black box' warning for an increased
risk of sudden death in patients with heart problems.
A black box warning is the most serious warning added to a drug's label
Earlier this year, two FDA advisory panels recommended new warnings and
information for all stimulant drugs used to treat attention deficit
hyperactivity disorder (ADHD). But the panels didn't quite agree on the
In February, one panel recommended a black box warning. But, in March, a
separate panel stopped short of recommending the black box warnings.
Since Adderall and Dexedrine are amphetamines, they already had a black box
warning about amphetamine abuse.
That black box warning for the two drugs now includes the following
sentence: "Misuse of amphetamines may cause sudden death and serious
cardiovascular events." Notice of the warning for Dexedrine appeared on the
FDA's site yesterday.
Ritalin and Concerta, two other drugs used to treat ADHD, aren't
amphetamines. So they don't bear the black box warning about amphetamine
However, they are stimulants and do carry warnings about the risk of sudden
death in people with heart problems. The FDA has not decided these drugs need
to carry a black box warning.
Ritalin is made by Novartis. Concerta is made by McNeil Pediatrics. Adderall
is made by Shire. Dexedrine is made by GlaxoSmithKline. All are WebMD
ADHD Drug Warnings
Warning information for all stimulant ADHD drugs includes the following:
Sudden death has been associated with stimulants at usual doses in children
and teens with structural heart abnormalities or other serious heart
Children, teens, or adults who are being considered for treatment with
stimulant medicines should have a careful checkup (including family history and
a physical exam) to check for heart disease.
Patients who develop symptoms such as chest pain during exertion,
unexplained fainting, or other possible heart symptoms should promptly get a
Sudden death, stroke, and heart
attack have been reported in adults taking stimulant drugs at usual
doses for ADHD.
Adults are more likely than kids to have serious structural heart
disease of the heart muscle), serious heart rhythm abnormalities, coronary
artery disease, or other serious heart problems.
Adults with such heart abnormalities should also generally not be treated
with stimulant drugs.
GlaxoSmithKline, maker of Dexedrine, said in a letter posted on the FDA web
site that it added the warning based on recommendations from the FDA advisory
WebMD contacted the makers of Ritalin, Concerta, and Adderall for their
In a statement emailed to WebMD, McNeil Pediatrics spokeswoman Julie Keenan
confirmed that McNeil Pediatrics has worked with the FDA to update the warnings
section of the prescribing information for Concerta extended-release
The update was "based on recommendations regarding use of stimulant
medications to treat ADHD from two FDA advisory committee meetings," Keenan
"We encourage parents whose children use Concerta to contact their
physician if they have any questions," she adds.
The makers of Ritalin and Adderall didn't respond before deadline.
The ADHD drug Strattera isn't a stimulant, so it doesn't carry the same
warnings. Strattera is made by Eli Lilly and Company, also a WebMD sponsor.