FDA Advisory Panel Recommends Black Box Warnings For Adderall And Other ADHD/ADD Drugs

Agency Wanted Some Ideas About New Safety Studies For These Increasingly Popular Stimulants

Reports of sudden deaths, heart attacks, and strokes in both children and adults taking drugs to treat attention deficit hyperactivity disorder (ADHD) prompted the FDA to convene an advisory panel committee of outside drug-safety experts in February 2006. The FDA asked the advisory panel to consider the issue of how best to study the potential cardiac risks of Adderall, Ritalin, and other stimulants. The advisory panel ultimately went further and recommended that a black box warning be put on Adderall, Ritalin, and other drugs used to treat attention deficit hyperactivity disorder.

Black Box Warning Recommended by Drug-Safety Experts

Specifically, the drug-safety experts recommended that a black-box warning be added now -- and not wait until any additional safety studies are done -- in order to make doctors and patients aware about the serious cardiovascular risks that are associated with Adderall, Ritalin, and the other ADHD/ADD drugs.

On February 8, 2006, a day before its meeting, this advisory panel received a collection of ADHD/ADD drugs "Briefing Information" prepared by the FDA which showed that during the time period 1999 to 2003 there were 81 deaths and 54 non-fatal cardiovascular events possibly linked to the ADHD/ADD drugs. These reports of adverse drug reactions included incidents involving Shire Pharmaceuticals PLC's Adderall, Johnson & Johnson's Concerta, Novartis AG's Ritalin, and some similar generic drugs.

Significantly, at the February 2006 advisory panel meeting it was learned that Adderall was involved in more fatal case reports than any other ADHD/ADD drug, with 24 deaths reported from 1999 through 2003 regarding patients who took Adderall for ADHD or ADD. After the meeting, Adderall's manufacturer, Shire Pharmaceuticals, issued a press release stating that while the compamy agreed with thet FDA's desire for more safety studies concerning Adderall, Shire disagreed with the advisory panel's recommendation that a black-box warning be put on Adderall.

No Black Box Warning After All

No sooner had the advisory panel announced its opinion that a black box warning was needed on Adderall and the other ADHD/ADD drugs than the FDA signalled that no label change would be forthcoming any time soon. According to news reports, Dr. Thomas Laughren, director of the FDA's Division of Psychiatry Products, made these remarks about the advisory panel's black-box warning recommendation: "We don't think anything different needs to be done right now.... We think the labeling right now is adequate."

In contrast, when members of this FDA advisory panel were asked to explain why they thought that Adderall and the other ADHD/ADD drugs should get a black-box warning, there is quite a different story told. Arthur A. Levin, director of the Center for Medical Consumers in New York City, maintained that "For us to sit around and talk about it, and for us to not make a very strong warning about the uncertainty of these drugs and their possible risks, would be unethical." Dr. Thomas R. Fleming, a professor of biostatistics at the University of Washington, said more bluntly that these "stimulants" might be far more dangerous to the heart than Vioxx or Bextra.

Back in January 2006 Dr. Peter Gross, the chairman for this FDA advisory panel, made the following remark about the lack of longer-term safety studies for Adderall and other ADHD/ADD drugs: "It almost sounds like cox-2 inhibitor redux" -- a foreboding reference to the 2004 recall of Vioxx that only came after the long "delayed" discovery that Vioxx substantially increases one's risk of heart attack or stroke.

In February 2005 Health Canada suspended the marketing of Adderall XR due to reports of sudden death, heart attacks, and strokes in pediatric and adult patients. Six months later, however, Health Canada reintroduced Adderall to the Canadian market in August 2005 not because the agency found Adderall to be safe but, rather, because "an independent panel found it impossible to accurately ascertain whether the drug increases the risk of cardiac death."