The various drugs used to combat attention deficit hyperactivity disorder, or ADHD, do not increase the risk of heart attacks, strokes or sudden death, according to a new study published in The New England Journal of Medicine that was funded by public health officials, who hope to resolve ongoing confusion over the cardiovascular risks of these drugs.
In reaching their conclusion, the researchers studied data from four health plans of more than 1.2 million children and young adults between two and 24 years old who were taking or had taken ADHD meds and found no increased risk of heart problems. In fact, just 81 cases of serious heart problems were found, suggesting the low number of events limited the statistical power of the study.
The study is one of three commissioned by the FDA after reports of heart attacks, strokes and sudden cardiac arrest in children taking ADHD meds were submitted five years ago to regulators, including Health Canada. The concerns prompted several FDA advisory committee hearings and Canadian regulators temporarily suspended marketing ADHD pills.
Meanwhile, the American Heart Association issue some controversial guidelines suggesting that children who were taking the meds for the first time should be tested for any possible heart problems. "After ADHD is diagnosed, but before therapy with a stimulant or other medication is begun, we suggest that an ECG (electrocardiogram) be added to the pre-treatment evaluation to increase the likelihood of identifying cardiac conditions that may place the child at risk for sudden death,” Victoria Vetter, head of the AHA statement writing committee, and professor of pediatrics at the University of Pennsylvania School of Medicine in Philadelphia, said at the time (see this).
But as the NEJM study notes, this led to "concern and confusion" among doctors and families about the risks of the drugs, although the AHA later revised its recommendations (here is the study abstract and here is the FDA statement).
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Gould et al published a case-controlled study in 2009 (below) that showed a statistically significant association between stimulant use in children age 7-19 and sudden unexplained cardiac death. Guess maybe FDA missed that one.
http://ajp.psychiatryonline.org/article.aspx?volume=166&page=992
Looks as if the results of this study will just add to the controversy, particularly in the area of sudden cardiac arrest
And of course, based on what is known (causing depression, growth retardation, etc.) their use should be outright banned in children. Instead, we have the American Academy of Pediatrics giving their imprimatur to give them to ever younger children.
Amen, Tim
Don't forget this one FDA
http://www.guardian.co.uk/society/2006/feb/11/health.medicineandhealth
Ritalin heart attacks warning urged after 51 deaths in US
Move to highlight risks of drug prescribed to hyperactive children
"The recommendation by an advisory panel of the Food and Drug Administration to put a "black box" warning - the most serious possible - on all ADHD drugs in the US is likely to be accepted. Pressure will mount now on the British authorities to warn publicly of the risk."
So all of the past reports are tossed out? Yeah, like we trust the FDA judgement! they also approved the sudden-death antipsychotic Saphris! among others!
This study and the one mentioned by OII came up with fairly similar conclusions if you read them closely.
The Gould article estimates that approximately 1.8% of sudden unexpected deaths in the 7-19 year age group were in patients with a history of stimulant use. The article cites prior studies suggesting that the rate of sudden unexpected death in this age group is somewhere in the range 0.8 to 8.5 per 100,000 patient years. This gives an estimated upper limit for the risk of stimulant-associated sudden death of 1 per 654,000 patient-years.
The NEJM article estimates the risk of sudden cardiac death at one per 100,000 patient years.
Comparing the annual risk of sudden death from stimulants with that of dying in an automobile accident (1 per 8,500 for the US population as a whole, probably 2-3x higher for teenagers), both studies find the risk to be less than 1/20th that of driving a car.
The Gould study has a strange disconnect, as they describe their motivation for conducting their study as being based in part on a previous study showing a 20-21% increase in cardiac ER and physician office visits for youth on stimulants, but their study find a 640% increase in sudden death which is implied to be cardiac in nature. The paper does not discuss this apparent discrepancy.
This is not to say that there may not be very good reasons not to treat kids with stimulants. But both of these studies suggest that the risk of sudden death is not high among them.
If you think amphetamine sulfate use doesn't increase the risk of adverse cardiac events, you're living in la-la-land.
I think we have consensus here on the cardiac dangers of stimulants and the ill-informed decision of FDA. I'm not a big fan of Public Citizen and Dr Sidney Wolfe, but I could see this as an issue that PC could bring up as a Citizen's Petition and try to get FDA to reverse its stand. I can't participate because of my ties to industry, but maybe some independent voice or group of voices out there in the public domain could take up the cause.
Mike S. not la la land, but data land. Read the studies.
Following the data when it takes us away from the direction of our preconceptions is why we don't burn witches anymore.
John, please present your "hard data" to the mother of a seven year old child with ADHD and a previously undiagnosed congenital heart disease who has a sudden cardiac death on a stimulant, then give your "hard data" eulogy to a churchful of grieving relatives and see how far that gets you.
OII, I'm surprised at your vehemence, as you are usually someone who does not react emotionally.
Does a person such as the one you mention exist? I'm sure that somewhere, he or she does. Just like there are people who wear steel masks or are quadraplegics because they lost their lower jaw in an auto accident. I'm sure you would not suggest that we ban automobiles because of this.
Both of these articles suggest the possiblity of an increased risk of CV events in juveniles treated with stimulants, but relative risk and absolute risk are different things.
If I buy a house with a roof built from plywood, my risk of being killed by a meteorite might be double what it is in a house with a roof built from closely spaced 4x4s and one inch boards. But since my risk in once case is one in a million, and in the other case its one in 500K, I'll probably decide which house to buy based on whether the roof leaks, and not based on the meteorite risk.
Likewise, doubling the risk of MI in a 15 year old may be a real effect. But as a practical matter, the rate is a small fraction of the risks we all subject our children to on a daily basis without giving it much thought.
John, I concede your point, and you've probably exposed my bias on this class of drugs. That bias is that stimulants are way overprescribed for children with ADHD and I believe that the psychological effect of FDA's decision on parents and prescribers will be to encourage more use of these drugs, thus fulfilling the Pharmacological Law of Unintended Consequences.
As you know, although childhood and adult onset ADHD are separate diagnoses, as a praactical matter many kids who are placed on these meds continue them as adults, and I think that we have pretty good data on adverse cardiovascular effects of stimulant druga in adults, such as sudden cardiac death due to ventricular fibrillation. You will note posts by academics on this board and other sources that attest to the widespread use of stimulants on college campuses in this regard.
Thus while technically "safe" in kids these drugs are time bombs in a tablet waiting to go off when they get older.
OII, I am not familiar enough with the overall literature to make a global judgment on the use of these drugs. I do find the statistics troubling.
I have a good friend who chose to treat his son with Adderall. My friend is the most loving, family oriented guy you would likely ever run across, and would never make a decision of this sort based on his own convenience. Nor is he a dupe who believes whatever recommendation he receives from someone with a degree. This was a long, drawn-out, carefully considered decision that was revisited at regular intervals.
So while I find the statistics very troubling, I would not take this choice away from someone who has researched it much more deeply than I have, and who has a much greater stake than myself in making the right decision.
However, given the stats, I can certainly understand how others might see it differently.
As always, it is good to hear your POV.