FDA Advisory Committee Recommends ‘Black Box’ Warning for Ritalin, Adderall, Concerta, and Other ADHD Drugs for Potential Risk of Heart Attacks, Strokes, and Sudden Death

In what many experts are viewing as an unusual turn of events, an FDA advisory panel has voted to recommend that the agency order the inclusion of the most serious “black box” warning on all stimulant ADHD medications due to evidence of a potential risk of heart attacks, strokes, and sudden death. The drugs include amphetamines, such as Adderall, and methylphenidates, sold as Ritalin, Concerta, Methylin, and Metadate.What makes this action (by an 8-7-1) vote surprising to critics of what they see as an influence-riddled agency beholden to the pharmaceutical industry and a system that “rubber stamps” the fully-expected recommendations of supposedly independent panels is that the FDA is now faced with a vote that is clearly against the best interests of the drug companies.Thus, rather than having a “safe” vote that the agency can simply endorse as its position on a drug, the FDA is already expressing its view of the vote in terms that strongly suggest it may not adopt the panel’s carefully considered recommendation. This has done little more than throw fuel on an already blazing fire.

The panel also voted 15-0-1 to recommend that the FDA require that the drugs include a medication guide for patients and parents.

All of this controversy was prompted by data that showed that widely prescribed ADHD drugs like Ritalin may be lined to as many as 25 deaths that occurred between 1999 and 2003. Of these deaths, 19 involved children. In addition, the FDA was advised of 54 cases involving serious cardiovascular problems like heart attacks, strokes, hypertension, heart palpitations and arrhythmias in both adults and children taking these medications.

There is also the open issue of another 26 deaths between 1969 and 2003 in medicated ADHD patients involving suicide, intentional overdose, drowning, heat stroke, and underlying diseases.

The panel’s vote also caught the FDA off guard because the committee was convened to advise the agency on how to design studies to assess possible risks associated with stimulant ADHD medications.

During the meeting, however, talk soon turned to the over-prescribing of these drugs and the public as well as many doctors were unaware of these serious potential risks. The panel then agreed to consider the enhanced-warning issue that was outside of its planned agenda.

In attempting to lay the foundation for ignoring the panel’s vote, officials said they would be reluctant to require a black box warning based on a “theoretical risk.”

Such warnings could unreasonably deter patients and doctors from using a drug that could benefit them, said Robert Temple, MD, director of medical policy at the FDA’s Center for Drug Evaluation and Research. He stated: “The absence of bona fide problems in your hand pushes against the box. We will also, frankly, worry about the possibility that overstatement can do active harm.”

Thus, Temple indicated the full FDA would wait for the recommendation a pediatric advisory committee scheduled for March before reaching any decision with respect to new warnings. That panel, which is made up of pediatricians and psychiatrists, is considered more likely to look favorably on the benefits of ADHD drug treatment as outweighing the potential risks.

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