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 information.
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 warnings.
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 use.
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 sponsors.
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 problems.
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 heart evaluation.
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 abnormalities, cardiomyopathy (a 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 committees.
WebMD contacted the makers of Ritalin, Concerta, and Adderall for their comments.
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 tablets.
The update was "based on recommendations regarding use of stimulant medications to treat ADHD from two FDA advisory committee meetings," Keenan says.
"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.
SOURCES: News release, FDA. GlaxoSmithKline: "Important Prescribing Information," Letter to Doctors, Aug. 4, 2006. Novartis: "Prescribing Information for Ritalin." McNeil Pediatrics: "Prescribing Information for Concerta." Shire: "Prescribing Information for Adderall." WebMD Medical Reference from Healthwise: "Pediatric Cardiomyopathy." WebMD Medical News: "Experts Urge Stern ADHD Drug Warnings." WebMD Medical News: "New Warnings Urged for ADHD Drugs." Julie Keenan, spokeswoman, McNeil Pediatrics.