http://www.nytimes.com/2006/03/23/health/23fda.html?th&emc=th
By GARDINER HARRIS
Published: March 23, 2006
GAITHERSBURG, Md., March 22 — Stimulants like Ritalin lead a small number of children to suffer hallucinations that usually feature insects, snakes or worms, according to federal drug officials, and a panel of experts said on Wednesday that physicians and parents needed to be warned of the risk.
The panel members said they hoped the warning would prevent physicians from prescribing a second drug to treat the hallucinations caused by the stimulants, which one expert estimated affect 2 to 5 of every 100 children taking them. Instead, they said, the right thing to do in such cases was to stop prescribing the stimulants.
On Feb. 9, a different advisory committee voted 8 to 7 to recommend that the Food and Drug Administration place its most serious warning label, a so-called black box, on the labels of stimulants to warn that they could have dangerous effects on the heart, particularly in adults. That recommendation grew out of reports that 25 people, mostly children, had died suddenly while taking the drugs.
The twin conclusions come more than 50 years after Ritalin was first approved to treat attention deficit disorder and hyperactivity. Since then, stimulants have become among the most widely prescribed medicines in the world. In the United States alone, about 2.5 million children and 1.5 million adults take them; as many as 10 percent of boys ages 10 to 12 do.
In addition to Ritalin, two other stimulants, Adderall and Concerta, are popular.
The drugs have been studied in hundreds of trials over five decades and have proven to be extremely effective. But they have always been controversial, with some experts saying they are overprescribed. It is a measure of the difficulty of uncovering the physiological effects of medicines that experts are only now grappling with some of the drugs’ serious, though rare, physical and mental effects.
Dr. Thomas B. Newman, an epidemiologist at the University of California, San Francisco, who is a member of the pediatric advisory committee, estimated that out of 100 patients treated for a year with stimulants, 2 to 5 will suffer serious psychotic episodes like hallucinations.
“It’s a small number, but it’s real,” said Dr. Robert M. Nelson, an intensive-care physician at Children’s Hospital of Philadelphia and chairman of the committee.
Dr. Kate Gelperin, an F.D.A. drug-safety specialist, told the committee that the agency had discovered a surprising number of cases in which young children given stimulants suffered hallucinations. Most said that they saw or felt insects, snakes or worms, Dr. Gelperin said.
Dr. Gelperin described the case of a 12-year-old girl who said that insects were crawling under her skin. Another child was found by his parents crawling on the ground and complaining that he was surrounded by cockroaches. In both cases, the hallucinations disappeared after drug therapy was stopped. The boy’s doctor persuaded his parents to give him stimulants again, and his hallucinations reappeared.
F.D.A. officials made clear to the advisory panel that they considered the reports of hallucinations a problem that deserved a label warning.
“We were struck by the hallucinations,” said Dr. Rosemary Johann-Liang, deputy director of the division of drug-risk evaluation at the F.D.A. “We felt it was a drug effect.”
The agency does not have to follow the conclusions of its advisory panels, but it usually does. Dr. Robert Temple, director of the Office of Medical Policy at the agency, said after the meeting that the agency would “turn quite quickly to implementing the recommendations we’ve gotten.”
Dr. Temple added, “The area of uncertainty is what to do about the black-box warning on cardiovascular risks in adults.”
After the advisory committee meeting in February, agency officials said they had no intention in the near future of placing such warnings on stimulant labels about their potential heart risks.
Wednesday’s panel, made up mostly of experts in pediatric medicine and psychiatry, discussed only the potential risks of the drugs among children, while February’s group focused mostly on the risks to adults. The pediatric panel agreed with the earlier group that children who have heart problems should probably not be given stimulants. But most children who die suddenly from heart ailments never knew they were at risk, and most children put on stimulant therapy are not given thorough heart evaluations.
“You can’t screen 2.5 million children” with intensive heart evaluation tests, Dr. Nelson said.
Thanks, Dad!
I really appreciate that you are always on top of these news articles. This is a phenomenon I have seen for years but have had a difficult time getting doctors, even psychiatrists, to pay attention to. Thanks for letting everyone know about this risk so we don’t have kids getting labeled psychotic because of drug side effects.
–- Steve
Re: Panel Advises Disclosure of Ritalin's Psychotic Effects
I post articles like these not because I am anti-med (which I am not), but because I believe that the patient (or in the case of a child, the legal guardian) should retain as much control over the process of treating medical and psychological problems as possible. If we are to make truly informed decision we need to know the honest truth, not marketing spin, not what some faceless dr. (who may have no actual clinical experience) theorizes and not what ever fad comes along.
The fact that a very small minority of children taking stimulants in chronic fashion experience similar adverse reactions that recreational abuers face is little surprise to me, but it is big news to have someone in a position of authority acknowledge it publically.
The important thing is not to end our use of psychotropics, but to get parents, practitioners and other professionals (like teachers perhaps) to be aware of what can go wrong, so they can watch for the onsset and correct the problem before really bad things occur.
Science, including medical science is supposed to be about truth. It is not supposed to be marketing for large corporations who could give a fig about the lives who may be ruined from “market expansion”. And Pharma actually benefits from many adverse events - should a new psychological problem occur from the first med, they have another one waiting to treat this, and so on.
But as always, you are welcome.
Re: Panel Advises Disclosure of Ritalin's Psychotic Effects
[i]Since then, stimulants have become among the most widely prescribed medicines in the world. In the United States alone, about 2.5 million children and 1.5 million adults take them; [b]as many as 10 percent of boys ages 10 to 12 do[/b].[/i]
The casual way these kinds of figures are being accepted reminds me of the frog slowly boiling to death as the temperature of the water in the pan gradually increases. Pretty soon, the figures will account for a majority of boys and it will be considered abnormal to sit still and pay attention in class (10% ON drugs, how many more not on drugs - another 10%? - more?). Parents probably now [i][b]expect [/b][/i]at least one of their children to be diagnosed with these capital letters.
If environmental factors don’t explain the children’s behaviors, where were all these behaviors (and the figures only speak to numbers taking these drugs - not total ‘diagnosed’) when I was young? Why is there no mention of this phenomenon in the history books for any era? Why are the pre-drug days of this “disorder” not spoken of in the same hushed tones as those when polio was rife? Or am I to believe that this “disorder” was just as prevalent 50 years ago and that Ritalin was, therefore, a long-awaited miracle palliative that was immediately prescribed to millions? If it wasn’t so prescribed, why wasn’t it? Should 50 x 2.5 million untreated baby boomers be looking to sue their family doctors? And, if 10% of boys were, for millenia, going untreated and, therefore, uneducated, how on earth did the world get to where it is today advancement-wise? Finally, as all Darwin theorists are no doubt asking themselves, why didn’t the “superior” female evolve into a position of power long ago?
Is it not more likely that, in this case, the supply sought out and created its own demand - either in cahoots with the demand-creators in the food, entertainment and divorce industries, or through one massive con perpetrated by the drug, medical and scholarly (governmental acquiescent citizen creators) industries. There is just something so Aldous Huxley-esque about the whole thing. As a person who believes that the basic design of the human body is perfect, the very idea of an inherent, unforced error in 10% of specimens is, for me, ludicrous (although I’m pretty sure there are many who would like to see that idea expanded upon).
Also, if 2.5 million children in America are taking these drugs, wouldn’t you expect a little more people to be participating on these forums? A parent may have decided to believe the official line, and may have decided to go with drugging, but surely 2.5 to 5 million parents and equal numbers of grandparents and other relatives’ groups (let’s call it 20 million concerned individuals), haven’t just accepted these things for their young loved ones without even a second thought? Is there no room for the belief that a massive illegal recreational market for these stimulants is in full swing. Just because a certain quantity of drugs is being sold, doesn’t mean that the same quantity is going down “legitimate” throats. Do you suppose that the drug industry cares who is driving sales?
The following except from a recent CBS news report into these panels’ findings may help to illustrate how the water is heated and the frog boiled:
http://www.cbsnews.com/stories/2006/03/22/health/main1429683.shtml
[i]”The FDA has struggled since last year with the question of how to communicate the potential risks associated with ADHD drugs.
Psychiatrists and mental health advocates said leaving the disease untreated could rival the risks the drugs may pose.”[/i]
Granted these lines are part of the reporter’s copy and do not [b]DIRECTLY [/b]quote any medical authority. All the same, can you spot a word that, given the scientific evidence so far, should not have been used?
Clue: It’s a really important medical distinction and it begins with “d”.
How long before everyone accepts that as fact also? How long before that frog soup is ready?
6 years ago my dd was placed on a stimulant and developed anxiety, anorexia, paranoia and hallucinations. When I talked with the dr about it, he said it couldn’t possibly be the medication because she was only taking 7.5mg of Adderall a day. When I researched the medication I found that all her symptoms were under Overdose Symptoms. Drs need to be better informed about the risks of stimulant medications and stop prescribing it for every little learning difficulty. More thorough evaluations need to be preformed to figure out what is truly going on.