Glaxo adds strong heart risk warning to ADHD drug
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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 Glaxo were up 6 cents, or well under 1 percent, at $54.50 in afternoon trade on the New York Stock Exchange.
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