A sharply divided panel of experts recommended that medications for attention deficit hyperactivity disorder carry the Food and Drug Administration's strictest warning about potential risks of heart damage and sudden death.
By a vote of 8 to 7, with one abstention, an advisory committee to the FDA said these drugs, including
Shire Pharmaceuticals Group's
Adderall contain so-called black box warnings to alert patients and physicians to the possible problems.
The FDA isn't bound by its advisory panels' recommendations. The vote came during a meeting when medical experts were being asked to determine "research approaches" that could be used to study whether ADHD drugs increase the risk of heart problems, according to an FDA description of the gathering.
Although the FDA "has received case reports" of sudden death and heart damage, "these reports by themselves do not establish a causal relationship" between ADHD drugs and cardiac problems, said Gerald J. Dal Pan, director of the FDA's office of drug safety, in a written introduction to the advisory panel meeting.
However, panel members decided to act more emphatically, recommending that the black box warning be instituted. If subsequent tests prove there's no link between the drugs and heart disease, the black box warning could be removed, said one panel member according to
The FDA identified 11 brand-name ADHD drugs and some generics. Some brand-name drugs are closely related -- such as Shire's Adderall and Adderall XR -- and most are stimulants. The nonstimulant is Strattera from
. Other prominent brand names include Concerta from
Johnson & Johnson
and Focalin from Novartis.
The label for each ADHD drug has an assortment of warnings. For example, Strattera has a black box warning that refers to reports of suicidal thinking among children and adolescents. Labels for Adderall and Adderall XR warn about abusing amphetamines, which could lead to sudden death and heart damage.
Twelve months ago, Canada's health department ordered
a temporary suspension of Adderall XR. The department wanted to review reports throughout the world saying there had been 20 deaths among children and adults taking the drug. Canada lifted the ban in August.
When Canada issued the ban, the FDA said it had talked to its Canadian counterparts, adding that it "does not feel that any immediate changes are warranted in the FDA labeling or approved use of this drug."