US advisers urge heart risk warning on ADHD drugs

By Lisa Richwine

GAITHERSBURG, Maryland (Reuters) – 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 recommended 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
heart beats 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 overscare 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.

Shares of companies making ADHD drugs closed mixed on
Thursday. Novartis closed on the New York Stock Exchange down
0.55 percent at $54.40 per share, while Glaxo rose 1.77 percent
to $51.85 and Lilly rose 1.08 percent to $56.30.

Shire ended trading in London up 0.86 percent at 880.94
pence per share.