Glaxo adds heart risk warning to ADHD drug

WASHINGTON (Reuters) – GlaxoSmithKline Plc has said it will
add a strong warning about possible heart risk to its attention
deficit hyperactivity drug Dexedrine, according to a letter
posted on the U.S. Food and Drug Administration’s Web site on
Monday.

Packaging for the drug will also include information about
possible psychiatric adverse events, like hallucinations and
mania, linked to stimulants, according to the letter dated
August 4.

Inclusion of the new warning comes after two FDA advisory
panels offered conflicting opinions over how strong such
warnings should be.

FDA representatives could not be immediately reached for
comment.

In March, an FDA panel said new information about heart
risks should be added to the labels for attention deficit
drugs. The outside experts stopped short of supporting a “black
box” warning — the strongest warning possible — saying they
did not want to scare off patients or their parents.

The panel also said ADHD drug labels should include
information about possible psychiatric risks.

In February, a different FDA panel recommended black box
warnings.

In its letter, Glaxo said it was adding the warning “in
response to a Food and Drug Administration … request sent to
the manufacturers of all CNS (central nervous system) stimulant
products approved for the treatment of ADHD.”

The British drugmaker said its drug will caution patients
and doctors that “misuse of amphetamines may cause sudden death
and serious cardiovascular adverse events.”

Dexedrine will also include warnings about the risk of
sudden death, hypertension and other concerns associated with
stimulant treatment in children and adolescents who have heart
problems.

Shares of Glaxowere up 6 cents, or well under 1 percent, at
$54.50 in afternoon trade on the New York Stock Exchange.