Black Box Warnings for Ritalin and Other ADHD Drugs
It’s official: an FDA science advisory committee has voted to recommend the most serious type of ‘black box’ warning labels for Ritalin and other stimulants used in the treatment of attention deficit hyperactivity disorder.
Following the FDA’s request that the panel consider additional ways of studying drugs used to treat ADHD (see our earlier article “FDA Reports on Deaths from ADHD Drugs”), an article carried by APA’s PsycPort reports that the science advisory panel immediately turned to the question of ‘black box’ labelling:
The 8-7 vote, with one abstention, by the Food and Drug Administration committee was to recommend adding “black box” safety warnings to ADHD drugs. Doctors prescribe the increasingly popular drugs to about 2 million children and 1 million adults a month.
The FDA isn’t required to follow the recommendations of its advisory committees but typically does.
The federal agency originally had asked the scientific panel to consider ways of studying the drugs, which include amphetamines, such as Adderall, and methylphenidates, sold as Ritalin, Concerta, Methylin and Metadate.
The agency’s own data suggested a link between the drugs and an increased risk of sudden death and serious cardiovascular problems, including heart attacks.
The panel quickly turned to a debate on whether it should consider new warnings for the drugs rather than simply discuss the need for more studies.
Panel member Dr. Curt Furberg said it would be “inappropriate, unethical behavior” for the FDA not to disclose to doctors and patients that there was uncertainty about the safety of ADHD drugs.
Dr. Steve Nissen told his colleagues they should push for the black box warning on the drugs’ packages.
The drugs already bear warnings related to the possible risk they could pose to patients with heart defects, the FDA’s Dr. Gerald DalPan said.
“We feel this warning is appropriate given our current knowledge of these drugs,” he said prior to the votes.
The balloting on warning labels followed an earlier 15-0 vote to recommend that the FDA require that the drugs include a medication guide for patients and parents.
A federal health official said Thursday that there was a strong possibility the drugs may be linked to the deaths of 25 people.
Also see our recent article on the methylphenidate transdermal patch for ADHD, to be marketed soon under the brand name Daytrana: “ADHD Patch to be Sold as Daytrana”.
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This article was last reviewed by on Friday, 10th February 2006. You can leave a reply below.
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25th February 2006
One of the voters,a PHD pharmacist, gave an interview stating he voted for the black box warning because he thought they were over prescribed. What does this have to do with a black box warning ,and evidence based decisions.
Black box warnings are now often being ignored.Why? because the FDA like the CDC are now aspiring to outdo FEMA in stupidity. How can I prescribe based on their recommendations when they base their most serious warnings on questionable evidence,private agendas,and often politics. Its time for our profession to demand the FDA become more than its present Chicken Little look alike agency.
27th February 2006
Hi William,
I can really appreciate what you’re saying: the question of whether particular drugs are over-prescribed doesn’t seem to have much of anything to do with the question of whether they ought to carry a ‘black box’ warning.
It sounds like the FDA has a long way to go before you’ll have full confidence in their recommendations.
All the best,
Greg
19th October 2006
My 8 year old son was said to have adhd.His school gave him a test.They said he is very intelligent but he wont do his work because he,s so hyper.I took him to the doctor, the doctor spent about 10 minutes with my son just talking no testing or anything and then wrote me a prescription for ritalin.I refuse to give it to him now after learning it could have caused the death of even one child.The school is literally labeling my child as a bad kid he hates school now.I’m so confused is ritalin risky or not [please help] Thanks, Karin Wiley
4th February 2007
What happened to these children 100 years ago? They grew up to be normal adults folks.As a Grandfather,I saw what these drugs were doing to my Grandson and relayed that to my daughter and she took my advice.I want all you young parents out there to be aware of the long term effects of these drugs and guess what, they dont know.I cant believe a parent can put their child on a drug for short term benefits,no matter what behavior the child shows.This has everything to do with the competative word we live in.Think before harming your child people.I have a hard time beliving that parents would put their kids on speed when 25 kids died after taking it last year.Patience is the answer folks.Your kids will be ok in the long run when you stop thinking pills can solve every malady in the world.They say Einstein suffered from this and he changed our understanding of the universe.In fact, it is my opinion that when you give your kids these drugs you are throwing him into one of Hawkins black holes.You dont know where you are going to end up.
1st March 2007
My daughter takes ritalin and does very well on it. She was newly diagnosed with ADHD at the beginning of the school year. She was struggling tremendously at school and very far behind everyone in her class. Don’t get me wrong we hate her being on ritalin but it has improved her greatly. She was unable to concentrate in school to the point where she could not learn. Her teacher comments that she can get her work done and she no longer is a turtle. We would spend over two hours every night doing homework with her and now it takes about 30 minutes. I think before you go blamming teachers and down talking parents that you need to take a look at every situation individually. Most medications have side effects and can potentially cause death. If you want to get technical we should put a black box on food because obesity is out of control in the united states. Obesity causes more of a problem than a child taking ritalin. This is a matter that gets a lot of down play in society because people tend to think it is not true or it is for teacher relief.