The statistics are alarming because people are using the drugs recreationally or to boost academic and professional performance. The scientists who published the study concluded that about 1.6 million teenagers and young adults had misused these stimulants during a 12-month period and that 75,000 showed signs of addiction.
Last month, the FDA's Drug Safety and Risk Management Advisory Committee held 2 days of hearings, and after listening to all the testimony and reviewing the data presented, recommended that all ADHD drugs carry a black box warning on increased cardiovascular risks.
This month, the Pediatric Advisory Committee is meeting on March 22, 2006, and will focus on neuropsychiatric adverse event reports and trial data on ADHD medications. The committee will also receive an update on efforts to better understand cardiovascular adverse events possibly related to ADHD medications, according to the FDA web site.
Allen Jones, speaking as a representative of the Alliance, told the panel the FDA should instruct the pharmaceutical industry to advise the FDA of all adverse events that have been reported concerning ADHD drugs immediately, and also it should demand that all clinical trials in possession of the drug companies be turned over to the FDA so that independent researchers can review them for adverse events.
"We don't have the luxury of time to wait for the future trials," he pointed out. "Children are dying," he said.
I grieve particularly today for the 51 dead of ADHD drugs that were announced yesterday by the FDA, she told the panel.
I guess my up-front message, front and center, she continued, is that you know that ADHD drugs can cause serious side effects and death, including sudden death, hypertension, myocardial infarction, stroke, and possibly bipolar disorder.
This being the case, she said, I urge you to recommend that these drugs have an appropriate black box warning placed on the label starting immediately.
Sandra Lucas, appeared at the hearing to speak on behalf of the Citizens Commission on Human Rights, a psychiatric watchdog group, and told the panel, we do know that the side effects of the stimulants are not only present, they are extremely serious and sometimes lethal.
So, she asked the committee, while the FDA ponders the problem of studying the issue and conducting the studies that may have inherent flaws, what real, immediate protections are to be put in place for parents and children?
During the hearing, Drug Safety panel member, Dr Art Levin, told the committee, I think we have to recognize that when a drug is approved and marketed the public assumes a level of comfort in the safety of that drug unless they are told otherwise.
And, for us to sit around and talk about this, he continued, to have three advisory committee meetings discussing the signals and not to make, at the very least, a very strong warning to people that there is uncertainty here about the safety of these drugs and that they need to be aware of that pending clarification I just think is inappropriate, unethical behavior.
Committee member, Dr Steve Nissan advised, we have to elevate the level of concern and if it slows the growth of this, that is probably appropriate because I think most observers would argue that ten percent of ten year-olds do not have this disease and what has happened is that this is out-of-control use of drugs that have profound cardiovascular effects and, as a cardiologist, I can tell you that, he said.