Advisers urge heart risk warning on ADHD drugs
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Drugs taken by millions for attention deficit hyperactivity disorder should come with strong warnings that they may raise some patients’ risk of heart problems, a U.S. advisory panel said on Thursday.
The committee narrowly voted to recommend the warning even though members agreed it was unclear if the drugs contribute to sudden deaths, heart attacks and other complications.
ADHD drugs include Novartis AG’s Ritalin and Shire Pharmaceuticals Group Plc’s Adderall.
“The data is only suggestive at this point, but because of the gravity of the side effect, namely sudden death, physicians need to be made clearly aware of that concern,” said Dr. Peter Gross, the panel chairman and head of internal medicine at Hackensack University Medical Center in New Jersey.
The Food and Drug Administration will consider the panel’s recommendation for a warning highlighted by a black box, the most serious type for prescription drugs. The committee voted 8-7 in favor of the warning, with one abstention.
Each month, doctors write about 1 million prescriptions for ADHD drugs for adults and about 2 million for children, FDA reviewers said.
Several panel members said there was reason to worry because the ADHD drugs are amphetamines or chemically similar drugs. Amphetamines are known to raise blood pressure, often a precursor to severe heart problems.
Dr. Steven Nissen, a panel member and cardiologist at the Cleveland Clinic, said many prescriptions likely were unnecessary and he hoped a new warning would deter some use.
“I want to get people’s hands to tremble a little bit before they write that (prescription),” Nissen said.
Fifteen members also voted to urge the drugs be dispensed with a patient-friendly guide that explained the risks.
FDA officials said they typically reserved black-box warnings for risks clearly linked to a drug. The FDA had asked only for input on how to study if cardiac problems were related to the widely used medicines.
An FDA report from April 2004 noted 51 U.S. deaths among patients taking ADHD medicines. Other reports described high blood pressure, chest pain, heart attacks, strokes, irregular heartbeats and fainting.
FDA officials stressed the drugs have important benefits for many children and adults with ADHD, in which people have trouble focusing and may be impulsive or hyperactive to the point it affects school, work or relationships. Strong warnings might discourage effective treatment, they said.
“You don’t want to over scare people with data that aren’t very solid,” Dr. Robert Temple, director of the FDA’s medical policy office, told reporters after the meeting.
Shire spokesman Matthew Cabrey said the company was open to revising the label for Adderall, which already carries a black box saying misuse of amphetamines may lead to sudden death or serious cardiovascular events.
Johnson & Johnson, which makes an ADHD treatment called Concerta, “supports FDA efforts to ensure appropriate labeling for all medicines to treat ADHD,” company spokeswoman Bonnie Jacobs said.
Concerta is part of a family of treatments known as methylphenidates that includes Ritalin and another Novartis drug, Focalin. Amphetamines for ADHD include Adderall and GlaxoSmithKline Plc’s Dexedrine.
All of those drugs are stimulants.
Another ADHD drug, Eli Lilly and Co.‘s Strattera, is not classified as a stimulant. It was unclear if the panel thought a cardiac warning should be placed on Strattera also, said Dr. Gerald Dal Pan, director of the FDA’s drug safety office.
“It’s our understanding that the committee excluded Strattera from the recommendations,” said Eli Lilly spokeswoman Jennifer Bunselmeyer.
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